Regulations on Radiation Protection and Use of Radiation (Radiation Protection Regulations)


Date FOR-2010-10-29-1380


Ministry of Health and Care Services


Published in 2010 Booklet 12


Effective 01/01/2011, 01/01/2014

Edited
FOR 2016-05-11-475

Changes
FOR-2003-11-21-1362

For
Norway

Legal

LOV-2000-05-12-36-section 6, LOV-2000-05-12-36-§7, LOV-2000-05-12-36-§8, LAW-2000-05-12- 36 § 9, LOV-2000-05-12-36-§10, LOV-2000-05-12-36-§12 LOV-2000-05-12-36-§13, LAW-2000-05- 12-36-§14, LOV-2000-05-12-36-§15, LOV-2000-05-12-36-§17, LOV-2000-05-12-36-§18, LAW-2000 12/05/36-§19a

Promulgated
02.11.2010 kl. 13.45


Corrected 11.01.2013 (commentary to § 6 changed to § 57 repealed)

Short Title
Radiation Protection Regulations

Chapter Overview:

Chapter I. Introductory provisions (§§ 1-4)
Chapter II. General provisions on ionizing and non-ionizing radiation (§§ 5-21)
Chapter III. Provisions on ionizing radiation (§§ 22-28)
Chapter IV. Provisions concerning occupational exposure to ionizing radiation (§§ 29-33)
Chapter V. Provisions relating to non-ionizing radiation (§§ 34-36)
Chapter VI. Provisions on medical use of radiation (§§ 37-53)
Chapter VII. Administrative provisions (§§ 54-56)
Chapter X. Final provisions (§§ 57-58)
Annex on exemptions limits, cf. § 2 fifth and sixth paragraphs
Comments on the individual sections of the Regulations on Radiation Protection and use of radiation (radiation Protection Regulations)

Adopted by Royal Decree. 29 October 2010 pursuant to the Act of 12 May 2000 no. 36 on Radiation Protection and Use of Radiation § 6, § 7, § 8, § 9, § 10, § 12, § 13, § 14, § 15, § 17 , § 18 and § 19a. Promoted by the Ministry of Health.
Changes: Amended by regulations 9 Dec 2011 no. 1223, 5 Dec 2014 no. 1514 12 Dec 2014 No.. 1586, 23 January 2015 No.. 59, October 9, 2015 No.. 1167, 18 Dec 2015 No.. 1588, February 5, 2016 No.. 103, May 11, 2016 No.. 475.
Corrections: 06/01/2013 (comments added without announcement), 11/01/2013 (commentary to § 6 changed to § 57 repealed)

Chapter I. Introductory provisions

§ 1. Purpose The purpose of this regulation is to ensure proper use of radiation, prevent harmful effects of radiation on human health and contribute to the protection of the environment.

§ 2. Substantive scope This regulation applies to any manufacture, import, export, transfer, possession, installation, use, handling and recovery of radiation sources.
Regulations also cover human activity which in itself implies increased natural ionizing radiation in the environment or leads to such radiation. These include radon in existing buildings and facilities where people can stay.
Regulation does not

A)
radon and other elevated natural radiation in dwellings and holiday homes where the owner himself staying or residing

B)
employer obligations in relation to radon levels in the workplace

C)
transport of radiation sources outside the closed area

D)
electrical appliances and components that unintentionally produce x-rays, the dose in normal use does not exceed 1 μSv / h from accessible surfaces, or the maximum energy of the radiation produced does not exceed 5 keV

E)
use of consumer articles containing weak non-ionizing radiation sources, unless they are covered by § 4 letter j.

Following radiation sources are exempt from the requirements specified in § 8 first paragraph j and r, § 11, § 12, § 16, § 17 and § 26

A)
use of smoke detectors containing less than 40 kBq Am-241

B)
using other allowable consumer articles containing radioactive substance

C)
welding electrodes containing thorium

D)
depleted uranium used as balance weights or shielding material.

Is it specified in the regulations, are also other radioactive sources exempt from the requirements specified in § 8 subsection r, § 12, § 16, § 17 and § 26 if the activity content not exceeding the exemption limits in the table in Annex. Exemption threshold in the table refer to maximum specific activity (Bq / g) / activity (Bq) of a source, or total activity at any time by individuals. Exceptions mentioned requires either total activity or specific activity is lower or equal to the exemption levels.
For working with open radioactive sources in laboratories exemption levels apply to the individual laboratory. With very different radionuclides simultaneously, the sum of the ratio of the total activity for each radionuclide and the corresponding exception threshold be less than or equal to 1. Illustrated, as an example:


Where Ak = activity of radionuclide k
AE, k = exception limit activity to radionuclide k

Ck = specific activity of radionuclide k
CE, k = exception limit for specific activity of radionuclide k.

§ 3. Geographical extent For Svalbard and Jan Mayen Regulations of 9 May 2003 No.. 568 on the application of the Act on Radiation Protection and Use of Radiation on Svalbard and Jan Mayen. In addition, the provisions of this chapter IV of Svalbard and Jan Mayen. Similarly, § 8, third, fourth and fifth paragraphs, and § 34 in terms of occupational exposure.

§ 4. Definitions Regulations understood with

A)

Activity: The strength of a radioactive source specified in the number of nuclear transformations (disintegrations) per unit time. Expressed in becquerels (Bq);

B)

Consumer article: An article or apparatus for use by consumers;

C)

Orphaned radiation source a beam source which is not under regulatory control, either because it has never been there, or because it has been abandoned, lost, misplaced, stolen or transferred without approval or notification;

D)

Medical use of radiation: The use of radiation on humans for medical examination and treatment, in occupational medical examinations, in screening programs, in forensic investigations, in insurance assessments or research;

E)

Nuclear medicine: Use of open radioactive sources in the form of radiopharmaceuticals for medical diagnostics or treatment;

F)

Radioactive radiation source radiation source containing radioactive substance, ie a substance that emits alpha, beta or gamma radiation;

G)

Encapsulated radioactive ray source: Radioactive material which is enclosed to prevent the spread of the radioactive substance into the environment;

H)

Open radioactive ray source: Radioactive material which is not encapsulated;

I)

Solarium: Apparatus with one or more ultraviolet radiation sources designed for irradiation of skin;

J)

Strong non-ionizing sources: sources that may lead to exposure of people and simultaneously exceeds limits set out in Guidelines on limited exposure two Non-Ionizing Radiation from the International Commission on Non-ionizing radiation;

K)

IPL: Intense pulsed light, intense visible light is pulsed, including in combination with radio frequency, ultraviolet or infrared radiation;

L)

Laser Pointer: Handheld laser, battery operated or with other self-powered with a voltage which is lower than 50 V AC and 75 V DC, intended to be held in the hand and pointing at something in the distance;

M)

Radiation dose / dose: Provision of energy per unit mass in an exposed individual or material from ionizing radiation;

N)

Screening: Systematic examination of a large group of asymptomatic people to identify their state of health in relation to a particular disease;

O)

Representative dose: The organization's own calculated dose value within radiology where dose value is based on the average of dose measurements at a given number of patients at a specific x-ray apparatus, for a given X-ray examination in which standard examination protocol is used;

P)

Representative Activity: The company's own calculated average value of administered activity for a typical nuclear medicine study. The representative activity is based on the average value of the administered activity to a group of adult patients by a standard procedure and an efficient system;

Q)

Diagnostic reference value / reference level: Assigned value used in the optimization of patient doses in studies;

R)

Exemption limits: limits, expressed in activity and / or specific activity, such as a radioactive substance can be exempted from all or part of the Radiation Protection Regulations;

S)

Occupational exposure: exposure which workers are exposed in connection with their profession, where the radiation source or exposure situation is a foreseeable part of professional practice and related thereto;

T)

Radon level: Radon concentration in air determined in accordance with current measurement procedures stipulated by the Directorate of Health;

U)

Employer: Ref. Employer concept as defined in the Act of 17 June 2005 no. 62 in § 1-8 (2) working environment, working hours and employment etc;

V)

Harmonized standard: Technical specifications adopted by European standards organizations in accordance with a mandate from the European Commission and EFTA countries. These standards are published in the Official Journal. Norwegian standards "harmonized standards", published by the Norwegian Standards Association or Norwegian Electrotechnical Committee in terms of electrotechnical standards.


For other definitions, see the law of 12 May 2000 no. 36 on Radiation Protection and Use of Radiation (Radiation Protection Act) § 3

Chapter II. General provisions on ionizing and non-ionizing radiation

§ 5. Eligibility and optimization All use of radiation shall be justified. For that radiation should be justified, shall advantages by allowing radiation to be greater than the disadvantages radiation causes. Furthermore, the radiation to be optimized, ie radiation exposure should be kept as low as reasonably achievable, social and economic conditions taken into account (ALARA principle - As Low As Reasonably Achievable).

§ 6. Limits and measures limit specific limits shall apply to individuals who are exposed to radiation.
Limit occupational exposure specified in § 30 and § 34
Threshold exposure of the general public and workers who are not occupationally exposed, is 1mSv / year of ionizing radiation. A business must plan radiation and its shielding measures so that no exposure to the public from the activities that may involve individuals being exposed to more than 0.25 mSv / year.
Limit exposure of the general public and workers who are not occupationally exposed is regulated in § 34 for non-ionizing radiation.
Radon mitigation measures shall be implemented in kindergartens, schools, etc. which is covered by regulations on 1 December 1995 no. 928 on environmental health in schools etc.. § 2, if the radon level exceeds 100 Bq / m3 (action limit). The same applies to homes where the owner is not living or staying. Radon level should not exceed a limit of 200 Bq / m3 in such buildings and premises.

§ 7. Dose limits for rescue work and rescue services in emergency situations should as far as possible operated well within the upper dose limits mentioned in § 30 first paragraph letters a to c. If the work can lead to doses exceeding 50 mSv, the work shall only be performed by volunteers who are informed thoroughly of the risks and the hazards involved. Women of childbearing age can only participate if they are not pregnant. Exceeding this limit can only be accepted in order to save lives, prevent serious damage or prevent a dramatic scaling up of the accident. Radiation doses above 500 mSv should as far as possible be avoided. The provisions of § 29 and § 32 shall apply accordingly.

§ 8. Approval Undertakings shall exercise the following activities involving ionizing radiation, should have the approval of the Directorate of Health:

A)
Exercise of industrial radiography and maintenance of industrial radiography;

B)
irradiators, ie the use of ionizing radiation on animals, other biota, materials, products etc. for treating, sterilizing, curing or other purposes;

C)
Logging activity, ie the use of sealed radioactive sources and accelerators for characterization of structures around the borehole;

D)
Comprehensive, non-medical research use of radiation;

E)
Administration of radioactive drug or substance associated with medical and veterinary diagnostics and treatment;

F)
Radiotherapy of people, including the use of accelerators;

G)
Use of X-ray diagnostic apparatus within the specialist health services, including plain radiography and fluoroscopy, angiography and intervention, computer-aided sectional imaging (CT), mammography and dedicated child diagnostics;

H)
Non-medical use of accelerators, less electron microscope;

I)
Manufacture and import of radioactive drug;

J)
Addition of radioactive substances in the manufacture of products, and / or sale of such products. Sales of consumer goods mentioned in Regulation § 2, fourth paragraph are exempt from the requirement for approval;

K)
Manufacture of radioactive sources;

L)
Use of open radioactive sources for tracer surveys outside the laboratory;

M)
Use of sealed radioactive sources with activities greater than 2 x 106 times the exemption levels in Appendix, cf. § 2;

N)
Use of open radioactive sources with activities greater than 104 times the exemption levels in Appendix and requiring a type A isotope laboratory, ref. § 26;

O)
Use of ionizing radiation for the control of persons for security purposes or search for hidden objects on the body;

P)
Import and export of strong radioactive sources that require approval by the letter m;

Q)
Extraction of radioactive substances associated with mining;

R)
turnover of radiation sources. Request for approval does not apply to radiation sources and applications mentioned in § 2 subsections.


Undertakings shall exercise the following activities involving non-ionizing radiation, should have the approval of the Directorate of Health:

S)
Obtaining and Using magnetic resonance imaging (MRI) for medical purposes.

It is illegal to own, possess, manufacture, import, export, transfer, handling, use and sell laser pointers Class 3R, 3B and 4, without approval from the Health Directorate. Approval is given only if:

1)
applicant can demonstrate that the laser pointer is designed, classified and labeled in accordance with the requirements of § 35,

2)
applicant can demonstrate that the intended use of the laser pointer is entitled in accordance with § 5, and

3)
there is no reason to assume that the laser pointer will be misused.

May be granted approval to both businesses and individuals. An approval may include multiple laser pointers and can be time-limited.
For applications for authorization under § 8 must procedural deadline mentioned in the Services Act § 11 first paragraph, be 30 days.

§ 9. Conditions for approval in approval may Health Directorate set further conditions to ensure proper use of radiation and prevent harmful effects of radiation on human health. This includes detailed conditions for the use of radiation, notification, reporting, expertise, physical protection, the use of measuring apparatus, maintenance procedures, quality control of apparatus and equipment for medical use of radiation, recycling schemes, financial guarantees, import and export, readiness and design of premises.

§ 10. Application for approval for approval under § 8 must apply in writing and given the information necessary for the Directorate to evaluate whether approval should be granted and what conditions should be set.

§ 11. Amendment or revocation of approval Health Directorate may revoke, modify or impose new conditions to approval pursuant to the Act of 12 May 2000 no. 36 on Radiation Protection and Use of Radiation, and if necessary withdraw approval if

A)
It turns out that the disadvantage of radiation usage is significantly greater or different than expected when the approval was given

B)
disadvantage of radiation usage can be reduced without unreasonable expense for business

C)
radiation may substantially reduced or jet use is replaced, ref. § 22

D)
conditions or restrictions which are arranged or provided in or pursuant to the Radiation Protection Act, materially or repeatedly disregarded

E)
when it comes to approval in accordance with § 8 or it otherwise follows from otherwise applicable conversion rules.

§ 12. Notification requirement Businesses that acquire, use or handling X-ray sets, accelerators and radioactive sources above exemption limits in the Annex, cf. § 2, fourth and fifth paragraphs, which are not subject to approval under § 8 shall notify the Directorate of Health. Businesses that offer solariums for cosmetic purposes for sale, rent or use shall notify the Directorate of Health. The notification shall contain a description of the system for age verification, cf. § 36, second paragraph. Radiation sources must not be acquired, used or dealt with before the business has received confirmation that the message has been received.
Requirement message also applies to the acquisition, use and handling of class 4 laser and intense pulsed light (IPL) and solariemodeller- and rørkombinasjoner, ref. § 36.
The notification must contain the information necessary for the Health Directorate to evaluate whether the activity covered by the notification requirement.
Businesses should, as far as possible, give notice in electronic form.

§ 13. Disposal of radiation sources Undertakings which procure sealed radioactive sources are obliged to ensure the existence of recycling schemes in the country of origin and to use these. Moreover, the undertaking is obliged to inform the Directorate of Health recycling scheme in connection with approval or notification pursuant to § 8 and § 12
Activities which disposes of radiation sources subject to approval or notification in accordance with § 8 and § 12 new users, return scheme or waste disposal, shall notify the Directorate of health about this. For open radioactive sources, it is sufficient that the business has updated lists of radionuclides and activity levels.

§ 14. Shutdown, shutdown, etc.. If a business has radiation sources stops the agency shall do so at any given time is required to maintain control of radiation sources. If the plant or business can cause adverse health effects after closure or shutdown, it shall within a reasonable time in advance given notice to the Directorate of Health.
Health Administration may require the owner or user to provide a guarantee to cover future expenses and possible liability.

Whoever wants to restart a business that has approval under § 8 or notified in accordance with § 12, after the business has been closed down or stopped for more than two years, should contact the Directorate of Health about this. Directorate of Health decides whether to apply for a new authorization before the business is started anew.
Undertaking is obliged to give written notice to the Directorate of Health without undue delay about change, transfer and termination of business activities covered by § 8 for approval or § 12 a message.

§ 15. Internal expertise, instructions and procedures The organization's duty of internal control stated in Regulation 6 December 1996. 1127 relating to systematic health, environment and safety work in enterprises.
Businesses should ensure that employees and other associated persons who install or work with radiation sources or who may be exposed to radiation, shall have sufficient expertise in radiation protection, including safe handling of radiation sources and measuring and protective equipment.
Agency shall prepare written instructions and procedures which ensure proper radiation protection and prevent people being exposed to levels that exceed limits stated in these regulations, applicable standards or international guidelines ref. § 35.

§ 16. Requirements for radiation protection coordinator Businesses that are subject to approval requirement pursuant to § 8 or notification pursuant to § 12 shall designate one or more persons who can be

A)
perform or have performed the measurements and evaluations to determine radiation doses

B)
supervise employees in the safe handling of radiation sources and the use of protective and measuring equipment.

The same applies to businesses that apply or install strong non-ionizing sources.
Radiation Coordinator will work to ensure that the business meets the requirements for health, safety and security as laid down in the radiation protection legislation. Number of radiation protection coordinators and organization of these will have to depend on your business structure and strålebrukens complexity.
By particularly extensive use or other handling of ionizing radiation sources must radiation protection coordinator could perform or have performed the physical, technical and radiochemical measurements and evaluations to determine radiation doses, and must also be able to assess health risks and consequences of different accidents and abnormal events that may occur .

§ 17. Risk assessment and preventive measures Businesses that plan to use or handle radiation sources shall identify and assess the risk factors associated with radiation. New activities involving radiation sources shall not be started until the risk has been assessed and appropriate preventive measures are taken. The risk assessment shall be documented in writing.
Showing reviews that there are risks for workers or other persons, or the radiation sources may go astray, the agency shall take steps to prevent such risks, including

A)
designing appropriate work practices

B)
use appropriate protective equipment and materials

C)
secure radiation sources against theft, sabotage, damage, including fire and water damage

D)
give employees the necessary information and training.

The requirements of this provision does not apply to radiation sources and applications mentioned in § 2 subsections.

§ 18. Emergency preparedness To reduce the possible consequences of accidents and abnormal events, the agency shall, on the basis of risk assessment, prepare a contingency plan and implement measures to maintain the ability to manage accidents and abnormal events.

§ 19. Notification obligation of accidents and abnormal events business shall notify accidents and abnormal events to the Health Directorate. Written report to be sent from the organization responsible for the Directorate of Health as soon as possible and no later than 3 days.
With accidents and abnormal events meant

A)
events that cause or could have caused accidental exposure of workers, patients or other persons significantly above normal levels

B)
loss or theft of radioactive sources

C)
Accidental release of radioactive substances into the environment

D)
incidents involving radiation to the general public so that individuals may be exposed to more than 0.25 mSv / year

E)
significant technical failure of radiation protection significance by radiation source

F)
significant deviation from adequate dose / activity to the treated tissue of a patient

G)
serious radioactive contamination of the business area or equipment

H)
findings of ownerless radiation sources.


§ 20. Requirements for oversight and control of radiation sources undertaking is obliged to have an overview and control of ionizing radiation sources. The same applies strong non-ionizing sources. This obligation entails that information on the location, source type and temporary relocations to be registered. For radioactive sources should also specification of radioactive substances and activities be recorded, as well as serial numbers or other information that uniquely identify the source. For open radioactive sources, it is sufficient that the business has updated lists of radionuclides and activity. For other sources of radiation must serial number, manufacturer / model or other information that uniquely identify the source, is detected.

§ 21. Requirements for radiation sources Owner, Dealer and manufacturer is obliged to ensure that the radiation sources are in such a state that the risk of accidents and abnormal events and undesired radiation exposure of users and other people is as low as practicable.
Radiation sources shall be in accordance with harmonized standards from Norwegian Electrotechnical Committee and Norwegian Standards Association.
Technical documentation on the radiation performance, instruction manual, maintenance descriptions and descriptions of radiation protection and safety, shall be in Norwegian or English, and apply the relevant harmonized standards.
Ionizing radiation sources shall be marked with the standard symbol for ionizing radiation. Symbol design stated prevailing NS-1029: Symbol to ionizing radiation. For radioactive sources, information about the source type, serial number or other information that uniquely identify the radiation source, and activity on a given date stated in the labeling.
For each device, there must be technical measuring protocol with the results of commissioning, acceptance tests and periodical checks of equipment, and maintenance and servicing reports.

Chapter III. Provisions on ionizing radiation

§ 22. Choice of radiation source substitution duty the use of ionizing radiation agency shall consider options, including whether it is possible to use methods that do not involve ionizing radiation. The business must then choose this option, if it can be done without unreasonable cost or inconvenience.
If radioactive sources must be used, these must be so low risk as practicable.
For non-medical use of radiation should be used røntgenapparat over radioactive sources when practicable.
Existing uses and methods reconsidered when new information emerges about their eligibility.

§ 23. Technical requirements for sealed radioactive sources and other ionizing radiation sources The enclosure shall be sufficiently strong to prevent leakage of the radioactive substance and shall comply with the requirements recommended in ISO 2919 (Sealed radioactive sources - classification). Leak test must be performed where the source encapsulation regularly subjected to mechanical or chemical wear and the concrete suspicion source encapsulation is damaged.
Industrial power sources in fixed installations containing radioactive sources shall meet the requirements specified in ISO 7205 for class xx2323xxxx with regard to radiation leakage. The equipment should also be constructed in such a way that it should not be possible to open or disassemble without the use of special tools, or be sealed in such a way that the radioactive source can not be removed without breaking the seal.
Fixed positioned equipment in closed systems for non-medical imaging and technical analyzes, including radiography in process, laboratory equipment containing encapsulated radiation sources or X-ray, X-ray baggage, body imaging equipment, etc.. shall

A)
be shielded so that the dose rate on the surface does not exceed 5 μSv / h

B)
have light or sound signals indicating when radiation is generated if there is an x-ray machine

C)
could generate radiation without use of a key or code if it is an X-ray apparatus.

§ 24. Storage of radioactive sources until they are scrapped Operations is responsible for the radioactive sources are stored properly.
This means that

A)
storage of open radioactive sources shall be limited to a minimum

B)
it at the storage yard, there must be a list of radiation sources, including activity level

C)
storage space to be secured against access by unauthorized persons

D)
storage should be clearly marked with warning signs about ionizing radiation in accordance with the regulation on 6 October 1994. 972 on safety signs and signaling in the workplace

E)
radiation level outside the storage space shall not exceed 7.5 μSv / h.

F)

Radioactive sources should not be stored together with explosives, highly flammable materials or corrosive environment.

§ 25. Shielding and safety Radiation shielding and other safety equipment such as personal protective equipment and safety systems must be present where necessary. These shall be constructed so that the risk of radiation doses to occupationally exposed, other employees and the public, cf. § 6, § 29 and § 30, and the risk of accidents and abnormal events is as low as practicable.
Agency shall regularly ensure that the safety and function as intended.

§ 26. Work with open radioactive sources and classification of isotope laboratories All work with open radioactive sources shall be carried out in isotope laboratory of type A, B or C, depending on the activity. Activity limits for the various types of isotope laboratories are as follows:

Laboratory Type
activity that can be used at a time in the laboratory

Type C
Up to 10 times the exemption levels for activity given in Appendix

Type B
Up 104 times the exemption levels for activity given in Appendix

Type A
Over 104 times the exemption levels for activity given in Appendix

Activity limits apply for normal chemical work. For simple work processes, such as withdrawal of stock solutions and dilutions, they can set limits be raised by up to a factor 10. In particularly hazardous work, including work with dry substances, the activity limits shall be reduced by a factor 10
When working with open radioactive radiation sources, measuring equipment for control of radioactive contamination is present. Measuring equipment and other safety equipment such as fume hoods and fans must be checked regularly.
Claims for laboratory class A, B or C does not apply to work with activity below the exemption levels in Appendix, cf. § 2, fifth paragraph.

§ 27. Requirements for isotope laboratories All isotope laboratories should be equipped and designed so that

A)
radiation doses to personnel can be kept as low as practicable

B)
risk of contamination and for the intake of radioactive substances is minimal

C)
surfaces are dense and smooth to facilitate cleaning and resistant to the use of chemicals that take place in the laboratory

D)
recycling of radioactive materials to the laboratory or other premises is prevented, normally using fume cupboards. If necessary to mount absorbent filters in the ventilation system

E)
sink can be made.

§ 28. Additional requirements for type A and B isotope laboratory Type A laboratory require authorization under § 8 letter n. The approval will include specific requirements for the design and equipment in addition to the requirements for Type B laboratory in this provision.
Type B isotope laboratory shall be reserved for operation with radioactive substances, and should be designed so that

A)
there is a transition zone into the controlled area containing kontamineringsmonitor, suitable wash basin and emergency shower. The transition to the active area must be clearly marked by painted stripe on the floor or physical barrier;

B)
lab has reduced air pressure relative to the surroundings so that radioactive substances into the working atmosphere

C)
ventilation for outgoing air is connected to a separate ventilation duct whose outlet is positioned so that air is not recirculated into the working atmosphere. The fan should be located near the outlet of the ventilation duct.

Chapter IV. Provisions concerning occupational exposure to ionizing radiation

§ 29. Requirements for classification and labeling of workplace activities shall classify workplace who controlled area, where employees may be exposed to radiation doses greater than 6 mSv per year, or if the dose to the hands may exceed 150 mSv per year.
Agency shall classify the work as a supervised area where employees may be exposed to radiation doses exceeding 1 mSv per year, or if the dose to the hands may exceed 50 mSv per year.
Agency shall ensure that occupationally exposed workers outside controlled and monitored area can not be exposed to radiation doses greater than 1 mSv per year.
Controlled area shall be physically demarcated, or otherwise conspicuously where physical demarcation is not possible. Controlled and supervised area shall be marked with signs indicating that this is a controlled or supervised area. Otherwise the requirements for labeling with the warning sign about ionizing radiation contained in regulations 6 October 1994. 972 on safety signs and signaling in the workplace.
The requirements for the labeling of the workplace does not apply at elevated cosmic rays and airline personnel.


§ 30. Dose limits mm. All radiation exposure should be kept as low as practicable, and following dose limits shall not be exceeded:

A)
dose limit for occupationally exposed workers over 18 years is 20 mSv per calendar year. Directorate of Health may grant an exemption for individuals, where the interests of the nature of work is not practicable to set an annual limit of 20 mSv. It may in such cases be authorized to practice a limit of 100 mSv over a continuous period of 5 years, provided that the dose does not exceed 50 mSv in any single year.

B)
radiation dose to lens of the eye should not exceed 150 mSv per year.

C)
The radiation dose to the skin, hands and feet shall not exceed 500 mSv per year.

D)
For apprentices aged between 16 and 18 years who use radiation sources as part of their training, apply instead of the doses indicated under ac dose of respectively 5, 50 and 150 mSv per year.

E)
For occupationally exposed pregnant should dose to the fetus does not exceed 1 mSv for the remainder of the pregnancy, ie after the pregnancy is known.

Requirements for resettlement of pregnant women, medical examinations of workers, physician notification, employer registration obligation mm. stated in regulations 14 June 1985 no. 1157 relating to work with ionizing radiation.
Where there is reason to believe that an employee has exceeded the dose limit, the employer shall immediately undertake a study to identify the causes and take steps to avoid repetition.

§ 31. Exceptions for radon provisions on classification and labeling of the workplace and dose limits mm. in this chapter shall not apply in relation to radon.

§ 32. Personal dosimetry agency shall ensure that employees who work within a controlled or supervised area, gets laid their personal exposure to radiation and the employee will contribute to this.
Agencies shall ensure that employees are informed in writing of the dose readings and take action when needed.

§ 33. Dose Reporting Businesses that even determines personal radiation exposure in their own business or on behalf of other businesses, shall regularly, and at least annually report to the interrogated doses to the Health Directorate. Doses should be reported on an individual level.
Individual Dose reports stored for 60 years.

Chapter V. Provisions relating to non-ionizing radiation

§ 34. Limit etc. Exposure of people All human exposure to non-ionizing radiation must be kept as low as practicable.
Guidelines and limits the field of optical radiation and electromagnetic fields given in the most recent issue of the Guidelines on limited exposure two Non-Ionizing Radiation from the International Commission on Non-ionizing radiation force of regulations.

§ 35. Use of IPL and strong non-ionizing sources For IPL and strong non-ionizing sources, including laser class 3R, 3B or 4, where human exposure is intentional, § 37, § 38, § 41, § 42, § 43, § 45, § 47, § 48 and § 53 insofar as they are relevant.
Use of strong non-ionizing sources shall comply with the following harmonized standards:

A)
EN 60825; Safety of laser products - Part 1: Equipment classification, Requirements and user's guide, and

B)
NEK IEC / TR 60825; Safety of laser products - Part 8: Guidelines for the safe use of laser beams on humans.

§ 36. Solariums Solariums shall be in accordance with harmonized standard EN 60335 with attachments; Household and similar electrical applianses - Safety - Part 2-27: Particular Requirements for appliances for skin exposure two ultraviolet and infrared radiation. Only solariums corresponding UV type 3 allowed for the sale, lease or use for cosmetic purposes. The importer / dealer a solarium, is responsible for ensuring that the requirements are met and that the necessary measurements are performed. Measurements confirming classification shall be performed by a laboratory that meets the CMO quality requirements.
It is illegal for businesses to offer solariums for cosmetic purposes by sale, lease or use of persons under 18 years. Firm must ensure satisfactory system for age verification. The following solutions are regarded as satisfactory:

-
Full Control, or partial control combined with subsequent electronic access.

-
Video Machine with document viewer associated MCC.

-
Other Type preflight and registration coupled with subsequent electronic access.

Agency shall explain the system in its message to the Health Directorate, ref. § 12. The system should safeguard users' privacy.

Responsible for the daily operation of the solarium as well as employees who deal with customers must have passed a knowledge test by guidelines set out by the Directorate of Health. The sample has a validity of five years.
Agency shall inform each customer about relevant risk factors for tanning use.
Importer and retailer is responsible for ensuring that the appliances are equipped with instructions for use and labeling of Norwegian EN 60335-2-27 with attachments, and marked with a warning to be placed easily visible and be resistant construction.
Undertaking is obliged to ensure that appliances and marking comply with applicable requirements and to inform the customer about the recommended schedule. The business is also obliged to have glasses available for the customer. Specification of permitted radiation sources shall be physically available at each model. Solari timer is to be set according to the recommended dosage schedule. The Company is liable to have spread with the warning and safety rules in accordance with EN 60335-2-27 with attachments, easily visible in the room.
Whoever imports or sells a solarium shall notify the Directorate of Health attached measurements, technical documentation and instruction manual dosing schedule in Norwegian, cf. § 12 Solariums must not be sold, leased or put into service before the relevant solarium is included on the list of allowed models published in "Health Directorate tanning overview."

Chapter VI. Provisions on medical use of radiation

§ 37. Eligibility The legitimacy of new methods and applications in medical use of radiation should be considered on a general basis until these taken into general use. Existing applications and methods reconsidered when new information emerges about their eligibility.
It should be considered whether the use of radiation is justified with regard to the individual patient's premises, and it should if possible be obtained before information about the patient in order to avoid unnecessary use of radiation. Irradiation can be justified in a particular case, although it is not generally deductible.

§ 38. Optimization Firm must continually look to the medical use of radiation is optimized. In optimization includes selecting the method, apparatus and equipment, evaluation of diagnostic information or treatment effectiveness, practical feasibility of examination or treatment, and evaluating the working techniques and radiation dose to the patient.
Each agency shall establish procedures relating to the common medical procedures are appropriate. The procedures shall provide information on methods and settings of apparatus for carrying out examinations and treatment. These procedures will be revised.

§ 39. Reference X-ray diagnostic, nuclear medicine and MRI and the treatments should only be undertaken after referral from health professionals with Requisition. The requirement does not apply to surveys conducted within the screening program in accordance with § 46
The legitimacy of the above surveys shall be assessed against professional guidelines before studies are conducted. In non-acute cases where the survey is particularly bothersome beam shall legitimacy considered by the appropriate medical specialist. cf. § 42 requirements for the medical expertise.

§ 40. Representative doses / administered activity to patient Firm must have a summary of representative doses / administered activity in patients typical x-ray diagnostic and nuclear medicine examinations. This value should be compared with diagnostic reference values ​​/ reference levels provided by the Directorate of Health. If the company representative dose / representative activity for a given survey is higher than the CMO reference value / reference level, the reason shall exist, and measures to reduce values ​​should be studied and implemented as far as practicable. Similarly, image quality and diagnostic confidence considered if the representative dose / administered activity is significantly lower than the reference value / reference level.

§ 41. Women of childbearing potential When processing or examination of women of childbearing age should be special attention is paid to the protection of the embryo / fetus, if the pregnancy exists or can not be excluded. In assessing eligibility shall take into account the expected dose to the embryo / fetus, if the examination or treatment may be delayed with respect to the woman's health condition and whether there are alternative methods that involve less risk of damage to the embryo / fetus.

§ 42. Medical expertise In organizations that use radiation to the following specified purposes, shall have personnel with the following competencies:

A)

By using X-ray and MRI which is subject to approval requirement pursuant to § 8 letter g and § 8 subsection doctor with specialist training in medical radiology or dentist with specialist training in maxillofacial radiology. Within specific disciplines, including heart disease and lung diseases; doctor with specialist training in their discipline.

B)
For nuclear research doctor with specialist training in nuclear medicine, by flermodalitetsundersøkelser such as PET / CT and SPECT / CT also a doctor with specialist training in radiology, if the apparatus is used for CT diagnostics.

C)
At high- and mellomenergetisk radiation therapy, physician specialist training in oncology.

D)
For skin therapy with tube voltage up to 15 kV X-rays, doctor with specialist training in skin and venereal diseases.

E)
For nuclear treatments, physician specialist training in oncology or nuclear medicine.

F)
By intraoral dentalradiografi, dentist, by additional oral dentalradiografi, dentist with relevant and demonstrable expertise.

G)
When using X-ray in chiropractor business, chiropractor.

H)
In other radiology without approval, doctor.

I)
When medical treatment with class 4 laser or IPL, doctor.

J)
When medical treatment with laser class 3B or other strong non-ionizing sources, doctor, chiropractor or physiotherapist.

K)
When medical treatment of oral cavity with optical sources, doctor or dentist.

L)
When treating eyes with laser, a doctor with specialist training in eye diseases.

M)
By phototherapy for jaundice in newborns, physician specialist training in paediatrics.

Within each category the business must appoint professionally responsible.

§ 43. Training in radiation and medical use of radiation personnel shall have annual relevant training in radiation protection and use of radiation in relation to working methods and individual tasks. All affected personnel should have device-specific training that includes matters affecting radiation dose and image quality before new apparatuses and methods are put to clinical use. All training shall be documented in relation to the scope and content of the individual employee.

§ 44. Expertise in medical physics Undertakings using radiation for medical purposes that require authorization pursuant to § 8, shall include scientific personnel at master level with competence in the relevant discipline of medical physics (radiology, MRI, nuclear medicine, radiation therapy). Number should be adapted to the scope and complexity, so that the necessary tasks are taken care of, including dosimetry, quality control, optimization. Professional responsibility physicist should have another two years of clinical experience.

§ 45. Competence to operate apparatus for medical use of radiation X-ray and MRI machines to be operated by a radiographer or a physician with appropriate specialist training, or dentist with specialist training in jaw and facial radiology. The requirement for specialist training does not apply to single portable apparatus for photography and radiography or the simple dentalrøntgenapparatur. CBCT / CBVT for use within kjeve-- and facial radiology can be operated by the dentist with relevant and demonstrable expertise. Chiropractor can serve simple X-ray apparatus subject to notification in chiropractic activity under § 12.
By radiotherapy should personnel operating the apparatus independently, have professional education that radiation therapist at bachelor level or further education within radiotherapy for other health professional education at the same level as the bachelor level.
Nuclear medicine apparatus shall be operated by personnel with health education at the undergraduate level (radiographer, bioengineer) with postgraduate studies in nuclear medicine and radiation protection equivalent to at least 15 credits in the higher education system, or physician with appropriate specialist training.
Operating flermodalitetsapparatur as PET / CT and SPECT / CT requires expertise in both nuclear medicine and radiography.
Lysbehandlingsapparatur for gulsottbehandling of newborns to be operated by healthcare professionals.
Laser class 3B and 4, IPL and other strong non-ionizing sources for human use, be operated by health professionals.
Personnel undergoing training in the above categories can operate such apparatus when this happens as part of their education.

§ 46. Screening Commercial mm. Screening programs and other exploration programs that use apparatus subject to approval ref. § 8, and which is aimed at symptom-free groups, must be reported to the Health Directorate. Business must if necessary also have approval for medical use of X-ray apparatus according to § 8 letter g. Otherwise, the following requirements apply to such activities:

A)

Program eligibility should be documented and based on scientific and social assessments.

B)
The program should be systematic and well-defined relative to the population covered and have procedures for monitoring positive findings and any bifunn.

C)
screening program should be able to document positive and negative findings so that the effect of the program can be evaluated regularly.

D)
The individual shall be informed about the disadvantages and consequences of the investigation.

E)
Technical and medical quality assurance program shall be available.

§ 47. Obligation to provide information requested by the Health Directorate undertaking shall provide information about the annual number of treatments and diagnostic tests for various medical and records of radiation doses to patients.
At the request of the Directorate of Health agency shall disclose to a technical measurement protocol for each apparatus, with results from commissioning, acceptance tests and periodical checks of equipment, and maintenance and servicing reports.

§ 48. Quality control etc. of apparatuses Apparatuses for medical use of radiation shall, as far as the requirements are relevant to such apparatus, fulfill the requirements stated in the Act on 12 January 1995 no. 6 concerning medical devices, and regulations issued pursuant thereto. This includes requirements for CE marking.
All apparatus should be maintained and controlled in a planned, systematic and documentable manner. The inspection shall minimum include parameters that affect radiation doses / deposited energy and image quality.
The apparatus used must be adapted to the respective applications.
Upon receipt and preparation of radiation medical apparatus for use requiring approval pursuant to § 8 shall reception control include all parameters and factors that may affect radiation dose and image quality. There will also be a documentable system for periodic quality control of apparatus and equipment.

§ 49. Dosimetry by ionizing radiation, radiology and nuclear medicine activities shall have a reference instrument for measuring the dose of radiotherapy. This reference instrument biennial calibrated against the national standard. Radiation sources used for radiotherapy should be calibrated against the reference instrument for the radiation qualities used clinically. Calibration of radiation sources for radiation therapy shall be effected by receiving inspection, maintenance affecting the dosimetry and for planned procedures and shall follow international protocols or national where given such.
All devices that provide a measure of patient dose in radiology and nuclear medicine must be calibrated / verified regularly.

§ 50. Radiology medical types of examinations data tomography (CT) angiography and intervention, conventional X-ray examinations of the gastrointestinal tract and surveys that are specially prepared for children, the following applies:

A)
X-ray apparatus shall be equipped with a device that gives a measure of the radiation dose to the patient during the examination.

B)
Individual registration of radiation exposure to the patient should be undertaken. These data shall be by the patient file or otherwise could be obtained.

Be developed standardized protocols for optimum adjustment of the apparatus for the most common medical issues. Such protocols are indicative apparatus shall be adjusted to what is optimal for the individual patient.
Doses of lenses of the eyes, breasts, thyroid and gonads should be kept as low as possible.

§ 51. Ionizing radiation treatment with ionizing radiation in order to cure disease or relieve symptoms to occur after proper professional and documented procedures for description of target volume, risk organ, fractionation and doses.
There should be tools for individual planning of radiation dose to the patient's anatomy, and there should be a program coordinator who knows the calculation models and the limitations of the tools. In connection with the start of treatment, dose calculation is controlled by at least two professionals. There must be a system for verification, where the treatment is checked against planned values. Changes in relation to the treatment plan must be documented. Manual transfer of processing data to the processing machine must be limited. Treatment should be documented so that it should be possible to reconstruct the treatment program, course of treatment and doses administered to each patient. The patient is entitled to information about radiation doses and risks of radiation.

There must be procedures for reporting and monitoring of deviations with separate register for various types of aberrations. Patients and possibly relatives notified by significant differences in processing. A dosimetric and medical assessment of the deviation determines further review of patient.
By external high-energy radiation must be a system of dosimetric and geometric control of processing documentation in the patient report.
In brachytherapy, the positioning of radiation sources in patient and treatment times documented.

§ 52. Nuclear medicine In nuclear medicine diagnostic activity shall be determined and verified before each administration to the patient.
In nuclear medicine treatment shall be made an individual dose planning and activity is determined and verified prior to administration to the patient
activity of radiopharmaceuticals, radionuclide, chemical form of radionuclides or its common abbreviation used shall be entered in the patient file.

§ 53. Treatment with non-ionizing sources Treatment with non-ionizing sources for the purpose of preventing and curing disease or relieving symptoms to occur after proper professional and documented procedures. The same applies when treatment purpose is cosmetic.
When dealing with non-ionizing sources should be a system for dosimetry based on an assessment or control measurements of the source dividends.

Chapter VII. Administrative provisions

§ 54. Supervision Directorate of Health should be given the information necessary to carry out supervision and monitoring of decisions made pursuant to the Regulations.
Health Directorate elects who of business representatives they want to talk to and retrieve information from supervised.
Health Directorate shall prepare a written report after inspection visits.
Health Directorate supervises solariums, including the authority to take the necessary decisions, delegated to municipalities, cf. Act on 12 May 2000 no. 36 on Radiation Protection § 18.

§ 54a. Detention, seizure and destruction of laser pointers Laser pointers are imported in violation of § 8 subsection may be withheld, seized and destroyed by the customs authorities.
Organisations carry out shipment and customs clearance shall notify the person who has imported laser pointer that laser pointer is withheld, the reason for this, and that it can be impounded and destroyed.
Whoever has imported laser pointer to comment within 10 days after notice is sent.
Have business that performs forwarding and customs clearance given an electronic address for receipt of electronic feedback, is the response timely submitted if it is determined that address by the deadline. Will be forwarded by mail operator, it is enough that its response before the expiration of the deadline is delivered to a postal operator to be sure to get the answer until the business that sent the notice under subsection.
If the person has imported laser pointer not issue a statement within the deadline, the laser pointer impounded and destroyed. Administration Act § 23, § 24, § 25 and § 27 shall not apply in such cases.
If the person has imported laser pointer statements on the matter within the period stated in the third paragraph, the Directorate of Health take specific decisions on the laser pointer be made available or be seized and destroyed.

§ 55. Exemptions If one or more provisions of these Regulations will be strongly unreasonable, the Directorate of Health grant an exemption.

§ 56. Amendments to the Regulations The ministry may determine changes in these regulations.
Health Directorate may issue and change exception limits in Appendix. By changing the exception limits, Directorate of Health determine the necessary transitional arrangements.

Chapter X. Final Provisions

§ 57. Entry into force This regulation enters into force on 1 January 2011 with the exception of § 6 subsection which enters into force on 1 January 2014. From the same date, the Regulations on 21 November 2003 no. 1362 on Radiation Protection and Use of Radiation ( radiation Protection Regulations).

§ 58. Transitional provisions Approvals granted pursuant to Regulation 21 November 2003 no. 1362 on Radiation Protection and Use of Radiation (Radiation Protection Regulations) § 5, apply until they are replaced with approval according to § 8, or until they expire.
The requirement in § 36 fourth paragraph applies from 1 January 2016. The requirements of § 12 first paragraph, third sentence, § 36, second paragraph, second and third sentences, and § 36 third paragraph, effective 1 January 2017.

Annex on exemptions limits, cf. § 2 fifth and sixth paragraphs

To read attachments for exemption limits see here:

Comments on the individual sections of the Regulations on Radiation Protection and Use of Radiation (Radiation Protection Regulations)


The comments are meant to deepen the content of certain provisions of this Regulation. The comments are not in themselves legally binding. Regulations and comments should be read together to get the best possible understanding of the provisions of the regulations.

To § 1: Purpose

Purpose related both to the protection of human health and protection of the environment. The term "preventing" means both preventing adverse effects and to limit any further damage. By the term harmful effect understood only undesirable effect.

To § 2: Substantive scope

Radioactive contamination and radioactive waste is primarily regulated by the Pollution Act and Regulations, see Regulations for Pollution Control Act apply to radioactive contamination and radioactive waste, set by the Ministry of the Environment on 1 November 2010 with the entry into force on 1 January 2011. The Norwegian Radiation Protection supervises also for these regulations .
Subparagraph:
Other examples of concentration of naturally occurring radioactive substances regulated by regulation is cosmic radiation to flight personnel and handling of scale (radioactive deposits from the oil and gas sector).
Third paragraph:

A)
Radon Level in new buildings is regulated by § 13.5 of the Regulation on technical requirements for construction works under the Planning and Building Act (regulation of 26 March 2010 No.. 489)

B)
Duties are regulated by the Working Environment Act and regulations and administered by the Labour / Labour Inspection.

C)
regulation applies transport of radiation sources within the enclosed area, for example in relation to risk assessment. Transportation of radiation sources outside the closed area is regulated by the Regulations on Carriage of Dangerous Goods (regulations 1 April 2009 No.. 384), the regulations on the transport of dangerous cargo on board the Norwegian ship (regulation 8 December 2009 No.. 1481) and the Regulation on transportation of goods in aircraft (BSL D 1-7) (regulation 11 January 2003 no. 41). Transportation of nuclear material is regulated by the regulations on the possession, sale and transport of nuclear material and multi-purpose products (regulation 12 May 2000 no. 433). This requirement in the Radiation Protection Act § 5 is considered preserved when transport regulations are followed.

D)
X-ray producing electrical appliances and components which are exempt can typically be cathode ray tube for image projection and electrical components in høyvoltanlegg.

E)
Non-ionizing radiation sources which are covered by the regulation is such phototherapy equipment, radar, telecommunications equipment, power lines, solariums and lasers.

Fourth paragraph:

B)
Other allowable consumer products are products that are not smoke detectors, and not prohibited by radiation regulations or other regulations. Example of other regulations are toy Regulations (January 4, 1996. 7). This means that the importer or retailer must make an eligibility assessment of the product before it is placed on the market in Norway, cf. § 5. Importer / dealer shall include assessment of the product in light of substitution requirement, cf. § 22

To § 3: Geographical extent

We refer to Report 2002 from the Ministry of Health: "Evaluation of the radiation protection legislation should be applied on Svalbard and Jan Mayen and Norwegian dependencies."
Generally working environment legislation on Svalbard. This follows from the Svalbard Act § 3. Regulations on work with ionizing radiation is issued pursuant to the Working Environment Act and is therefore regarded as Svalbard. Radiation Protection Regulations § 3, second sentence provides that provisions of the regulations relating to occupational exposure should apply to Svalbard (and Jan Mayen).

To § 4: Definitions

D)
Medical use of radiation also includes dental radiation use. Medical use of radiation involves some cosmetic use, cf. § 35. Veterinary Medicine is not covered by this definition.

J)
strong non-ionizing radiation sources may be base stations or apparatus employing electromagnetic field or optical radiation of cosmetic, dental or medical or industrial machines. The guidelines from the International Commission found on their website, www.icnirp.de.

L)
Laser Pointer does not include laser where the laser is part of a view, part of a toy covered by toy Regulations (January 4, 1996. 7), or a tool whose purpose is surveying.

M)
term radiation dose can, depending on context, refer to various dosimetric size organ dose, effective dose, miljødoseekvivalenten mm in units of Gy or Sv or decadal prefixes of these as a finger or micro. Dose rate may have device Sv / h or Gy / h, or decadal prefixes of those who mSv / h or μSv / h.

N)

Screening Program must follow national guidelines for screening set by health authorities (see NOU 1997: 20 Section 7.2). Unsystematic health checks of healthy individuals are not defined as screening program.

Q)
diagnostic reference value / reference level should serve as a basis of comparison for the company's own values ​​for representative dosage / activity, cf. § 40.

S)
Other workers are subject to the dose limits for the general public. For workers, such as emergency services, exposure to radiation normally not be foreseeable, but § 7 concerning dose limits for rescue work, apply. An employer who in their work are exposed to radiation also falls under the definition occupational exposure.

To § 5: Eligibility and optimization

Although exposure is below thresholds that exposure be reduced if it can be done without significant inconvenience. For eligibility and optimization of medical use of radiation is also referred to in § 37 and § 38

To § 6: Limits and measures limit

Third paragraph:
limit for exposure of the general public at 1 mSv per year applies to all planned use / activity. Of accidents and incidents to the public, measures could be taken to reduce doses in line with international principles, but it can not be excluded that the doses are higher. For rescue work, § 7. The requirement that each activity should limit exposure of the public to 0.25 mSv per year is based on the likelihood that individuals will be exposed by more than 4 different businesses are very small. Exposure of the patient are not included.
Subsection:
Radon requirements include practically all kindergartens, primary and secondary schools, both public and private. The requirements must always be fulfilled when people are present in the building. The provision also includes dwellings where the owner did not even live, ie rental housing. This includes both publicly owned and privately owned rental housing, including large tenements and privates rental of room / apartment adjacent to his own residence.
The limit is 100 Bq / m³. This means that if the measured radon levels above 100 Bq / m³, such as 150, 400 or 2000 Bq / m³, it must be taken to reduce radon levels. ALARA principle in § 5 also means exposure to radon should be as low as practicable. In practice, this means that radon levels be reduced even if the levels are below the limit value, but only if this can be done without significant disadvantages (see commentary on § 5). Exceeding radon level 200 Bq / m³ are required measures until the level is reduced to as low as practicable, and no matter always below 200 Bq / m³. The limits apply to living.
Relationship with regulations on environmental health in kindergartens, schools etc .:
Regulations on environmental health in kindergartens, schools, etc. § 19 fourth paragraph reads: "Ionizing radiation shall not exceed a widely accepted level." When it comes to radon, that provision shall be construed in accordance with the Radiation Protection Regulations § 6 subsection.

To § 7: Dose limits for rescue work

Although businesses do not have the personnel defined as occupationally exposed, the personnel for example in emergency bumping into situations where they are exposed to radiation. If a risk assessment shows that personnel may be exposed to more than 50 mSv shall be established procedures which ensure that work performed by volunteers who are carefully informed of the risks. The "volunteers" in the second sentence, means that this is effort that can not be imposed by the employer.
Implementation of longer-term measures such as removal of pollution, waste management etc. shall be planned and optimized in advance so that implementation is most identical to normal practice. If an accident results in pollution of the environment, the dose to those who carry out their normal work in this environment increase. This may apply to farmers, forestry workers, etc.. This work is not associated with rescue work in connection with the accident / incident, but those concerned are considered part of the public.

To § 8: Approval

Subsection:
approval of the businesses may also include approval of the premises to be used. f. ex. will approval under § 8 letters b), e), f), i), k) and n) include consent for development or approval of the premises to be used. This means that plans and descriptions should be sent to the Norwegian Radiation Protection Authority in the planning stage. This applies in connection with major changes to existing laboratories and eksponeringsrom / bestrålingsrom.

A)

With industrial radiography means the use of ionizing radiation sources for non-destructive testing (NDT) and corresponding use of radiation sources in other contexts, for example. Customs context and security objects. The term does not include the use of radiation sources for technical analysis, general product inspection or survey of material composition.

B)
See also regulations concerning the treatment of foodstuffs with ionizing radiation § 7.

D)
Comprehensive non-medical research use of radiation is particularly relevant for research institutions, universities, colleges and other businesses that use radiation in several laboratories and for multiple purposes. Request for approval does not apply to the use of ionizing radiation in education and routine analysis.

E) -g)
requirement for approval of the medical use of radiation includes practically all radiotherapy, nuclear medicine, radiology, røntgenveiledede procedures (such as intervention, spectroscopy, operation, etc.) and advanced dentistry with sectional imaging (eg . CBCT). The requirement for approval shall not include general dentistry (intraoral and simple extra oral (ortopantomograf (OPG) and chefalostat)), simple bride diagnosis of extremities and easy use of X within chiropractic activity and osteoporosis research. Veterinary nuclear medicine is also subject to approval obligation (ref. E).

Coordination Reform decentralization of radiological services into municipalities (ie primary care) also requires approval if radiology usage goes beyond the exceptions outlined above.
It should be noted that the requirement for approval also includes the use of radiation sources in research use of radiation on humans. This means that the business must have approval for use of topical radiation source, if it is subject to approval duty. The approval does not include the research project itself, as this is handled by the Regional Ethics Committee (REC).

O)
Applicable use of body scanning. Examples of such use fluoroscopy x-ray in customs control and security.

Q)
Examples of radioactive substances that can be recovered in connection with mining thorium and uranium. Mining in general is regulated by the mining legislation.

T)
Approval may be granted to any applications requiring stronger laser pointer than class 1 or 2 if the applicant can demonstrate the need. This is referred to the supervisor 12.

To § 9: Terms of approval

When approving the medical use of radiation emphasizes that the business must have a verifiable system for ensuring quality which include but are not limited to:

-
How responsible for radiation protection and radiation use is safeguarded, organized and distributed, including description of responsibilities for academic administrators at various levels in the organization.

-
Designated radiation protection coordinator, among other things will serve as the company contact person in relation to the Norwegian Radiation Protection Authority.

-
Requirements for notification of all radiation sources.

-
System for education, training and maintenance of competence for affected personnel in radiation, working methods and apparatus for medical use of radiation.

-
Procedures for maintenance and quality control of apparatus for medical use of radiation.

-
Protocols for the most common medical procedures in radiology and nuclear medicine diagnostic / treatment.

-
Procedures for determining representative values ​​for dose or administered activity in diagnostic and nuclear medicine examinations.

-
Necessary dosimetrifunksjoner for radiation therapy and diagnostics.

-
Description of target volumes for radiation therapy with the determination of doses and fractionation.

-
Procedures for planning and implementation of radiation that ensures geometric and dosimetric accuracy, as well as procedures for clinical monitoring of the patient after treatment.

-
Measures to limit the radiation dose to relatives or to third when patients with residual activity printed hospital or die.

-
Instructions for internal transport of radioactive material.

Regulations relating to systematic health, environment and safety work in enterprises (regulation 6 December 1996. 1127, internal regulations) poses further demands on businesses.

To § 10: The application for approval


For approval must inter alia prove that it has an organization that can radiation protection and radiation safety, that it possesses sufficient expertise in radiation protection, and that it has the necessary measuring equipment and other safety equipment. Standardized application forms for many types of businesses can be downloaded from the NRPA website. By expansions or substantial changes in the business jet operation, a new application for approval is submitted for review, see. §11 a).

To § 11: Amendment or revocation of approval

In making decisions under § 11 shall take account of the costs that amendment or revocation will apply the business, and the advantages and disadvantages modification or revocation will entail. What is "significant" and "unreasonable" will in the specific case depend on their assessment of NRPA.

A)
provision applies both when disadvantage because one has received new information after the approval was granted, and when conditions have changed so that the effects of radiation is worse than expected.

B)
provision includes breach of conditions stipulated in the approval and material breach of duties relating to approval.

To § 12: Notification requirements

Subsection:
Examples of medical radiology that just is subject to notification is intraoral dental x-ray (bite-wing), simple extra oral dental X-ray (ortopantomograf (OPG), cephalostat), photography by extremities (Simple Bride diagnostics), simple X-ray use in chiropractic activity and osteoporosis research. Veterinary X-ray is also only subject to notification. See also Note to § 8 e) -g).
Subparagraph:
New sunbed models must be reported. Overview of documentation that must accompany the message is linked up to the report form on NRPA's website.
Solari Models who are already registered on Radiation overview of cosmetic solariums need not be reported. Changes in these must be reported. Change can be a change, new pipes and lamps, new filter types or other information of relevance to UV radiation.
Solariums are also governed by a regulation on 6 May 1998 no. 581 on hygiene requirements for hairdressing, skincare, tattooing and ear piercing businesses etc. The agencies shall under these regulations shall notify the council.
Third paragraph:
For the NRPA to evaluate whether the activity covered by the notification obligation, the message must contain information that specifies the type of radiation source comprising (eg. X-ray apparatus, radioactive source, laser or tanning business), as well as information specifies the appropriate radiation source closer. Current information being requested either be notified in electronic form or whether it is used paper forms found on NRPA's website.

To § 13: Disposal of radioactive sources

Subsection:
The country of origin means the country of sealed radioactive source sent to Norway from, either as a source capsule is assembled in equipment / facility entry or as a source capsule to be installed in facility / equipment in Norway . With existing recycling scheme, meant a return scheme that is accepted by the government of that country.

To § 14: Shutdown, shutdown, etc..

Provision supplements Pollution Act § 20 so that health prevented with notice to the NRPA in connection with the shutdown and downtime.

To § 15: Internal Expertise, instructions and procedures

Subparagraph:
There may be requirements for competence in approval, cf. § 8. See also the regulation of 6 December 2011 No.. 1357 on the performance of work, use of work equipment and associated technical requirements (regulations on execution of work) ch. 16 on artificial optical radiation.
Third paragraph:
instructions and work procedures may be required in the following situations:

-
Where radioactive sources to be moved in and out of sheltered position.

-
Where there is risk of spillage from open radioactive sources.

-
For maintenance of marking ol

-
For transportation within the company's own area.

-
Where there is a risk of exposure from powerful industrial laser class 3B or 4

-
Where it used UVC disinfection in the food industry.

-
By radar installations on small vessels.

-
When using other strong non-ionizing radiation sources in medicine, cosmetic treatment or general application.

-
When servicing solariums.

Internal control regulations also include requirements for written instructions and procedures to ensure patient radiation protection.

To § 16: Requirements for radiation protection coordinator


This paragraph describes the function and academic requirements for radiation protection coordinator. Designation of radiation protection coordinator can not diminish the owner's or the employer's overall responsibility for all matters within the firm, but will ensure that the company's radiation protection function satisfactorily. Radiation Coordinator shall also be a contact person for the supervisory authority. Number of radiation protection coordinators and organization of these will have to depend on your business structure and strålebrukens complexity. In larger organizations, it may be expedient with one central and several local radiation coordinators.
Radiation Coordinator must have expertise in radiation protection. The scope of competence will depend on the type of business and applications of radiation sources. This paragraph implies that the radiation protection coordinator at major enterprises in medical use of radiation is medical physicist, or have access to a medical physicist with expertise in radiation protection, ref. § 44. Radiation Coordinator shall safeguard safety aspects, ie radiation safety for the employees and any third parties (visitors, neighbors etc .), as well as internal audits. Requirements for patient protection is given under Chapter VII.

To § 17: Risk assessment and preventive measures

Risk consider Scope will vary according to the nature, activities, risks and size.
Risk by intentional exposure of humans, such as medical and cosmetic use of radiation, must also include the risk of large doses to patients / clients and acute radiation injury in that regard, due to device failure or misuse this occasion. lack of training etc.
provision also includes emergency services.

To § 18: Contingency

Contingency plan shall be based on risk assessments and should include notification procedures, emergency organization, responsibilities, pre-planned procedures for handling certain situations, the procedures for mapping the extent of an event, communication procedures, description of relevant protection procedures for monitoring personnel involved, procedures for information to the authorities and population etc.

To § 19: Notification requirement accidents and abnormal events

Subsection:
accidents and abnormal events shall be notified immediately as soon as possible, but if there is acute danger to life, health or the environment, it can be notified during normal business hours to the Norwegian Radiation Protection, which is the responsible authority for further notification and reporting of various incidents. Notification can be made orally, but must be confirmed in writing and should include information on: time and place of the event, contact information, events (incl. Information about the type of radiation source, the possibility of radiation doses to individuals and environmental pollution).
Written report shall be submitted within 3 days and must contain comprehensive information, including an assessment of possible exposure of persons involved and any plans for prevention and risk reduction measures.
Subparagraph:
Examples of accidents and incidents to be reported under this section:

-
Workers who accidentally come into primary radiation field from industrial radiation sources. Improper use or failure of the apparatus that have or could have resulted in significantly elevated dose to the patient or operator.

-
People who have accidentally entered the controlled area and thus may have received doses exceeding 0.25 mSv, for example, stay within the enclosure of the industrial radiography, internal cleaning of tanks with the radiation source (level guard) in open position.

-
High huddoser that can cause burns on the patient within radiology and intervention. For accident reporting within radiotherapy appear to notice discrepancies reporting under § 51. Inadvertent irradiation of the fetus with fetal dose of 20 mGy.

-
Spilled radioactive solutions (contamination) which can not be removed in a simple way.

-
Findings of ownerless radiation sources is particularly relevant for organizations that treat different types of waste, such as smelting / scrap dealers. These businesses should have routine search for any ownerless radioactive sources and routine for handling the findings of such sources. Requirements for handling radioactive waste set out in regulations on the Pollution Control Act apply to radioactive contamination and radioactive waste and by waste ch. 16.

To § 20: Requests for oversight and control of radiation sources

Clause means that enterprises must have an overview of UVC sources and localization of mobile radiation sources, such as. mobile C-arms.
For shielding containers containing uranium refer to the regulations regarding the possession, etc. of nuclear material and multi-purpose products.
Activity specified in units of becquerels (Bq), cf. The definition in § 4.

To § 21: Requirements for radiation sources


See also § 48 where requirements for quality control of medical stråleapparatur given.
Subsection:
requirement is aimed owner, retailer and manufacturer that everyone has a duty to ensure that the radiation sources are appropriately designed for radiation safety. The owner / user is obliged before use to ensure that the radiation source is in good condition.
Subsection:
frequency of periodic checks must be adapted to the rigors equipment exposed. Mobile equipment used under varied / harsh conditions should be checked at least annually, while firmly placed equipment used under stable conditions do not need to be checked as frequently. It should nevertheless not go longer than three years between each periodic inspection.
The need for periodic inspections of equipment should be included as part of the risk assessment to be carried out acc. requirement in § 17. These periodic inspections are in addition to the requirement in this section the first paragraph that the owner / operator is obliged to ensure that the radiation source is in good condition prior to use, ie the more frequent / daily checklist.
For medical devices will the frequency of periodic checks depend on the equipment complexity and use rate. For advanced equipment will often be required quarterly controls, while annual inspections will be sufficient for less sophisticated equipment. See also § 48.

To § 22: Election of the radiation source - substitution duty

Requirements apply apparatus for imaging and analysis in industrial and research purposes, and does not include medical X-ray equipment, etc.. Apparatuses for medical diagnostics regulated in Chapter VI.
Subparagraph:
Radioactive radiation sources are considered to have a lower risk the lower activity they have, and sealed radioactive sources considered to have a lower risk than open radioactive sources.
Third paragraph:
Construction based on X-rays to be used as possible instead of facilities with radioactive sources where practicable. Eg. There are now construction for irradiating blood products that are based on the use of X instead of sealed radioactive sources with high activity. When purchasing new equipment or replacing existing facilities for irradiation of blood products, NRPA seldom approve new construction based on large sealed radioactive sources.

To § 23: Technical requirements for sealed radioactive sources and other ionizing radiation sources

The requirements apply to all apparatus for imaging and analysis in industrial and research use of radiation, as well as for sealed radioactive sources within the medical use of radiation. Requirements do not include medical X-ray equipment. Apparatuses for medical diagnostics regulated in Chapter VI.
Subparagraph:
With control source means a measuring apparatus or process which is activated by exposure to one or more sealed radioactive sources. The control source normally includes a source container and a detector. ISO Class xx2323xxx means that the source container must be designed so that the radiation level does not exceed 500 μSv / h in a distance of 5 cm from the surface and 7.5 μSv / h at 1m distance from the source container. The other numbers and bokstavangivelsene ISO classification indicates other technical and physical characteristics of the source container, and may have different values.

To § 24: Storage of radioactive sources until they are scrapped

The business room for interim storage of spent radioactive sources which shall be discharged or disposal is not regarded as a waste facility.

F)
requirement that radiation sources should not be kept together, ie they should be kept separately (for example in separate fireproof safes), but may be in the same room.

To § 25: Shielding and safety

Other safety may include:

-
Personal protective equipment blygummiforklær, transportable screens, pipetellere mm

-
Technical security systems that interrupts irradiation if a door or locks open.

-
Stop switches and warning signs with illuminating text that radiation is generated.

-
Radiation Monitors mm

-
Special Tools, shielded containers mm

Control of safety may include fluoroscopy of blygummiforklær to test shielding ability.
Radiation shielding also includes structural shielding. Requirements for structural shielding will vary with applications, and more detailed recommendations are given in the instructions. Structural shielding must be documented, for example. in the form of drawings, pictures or measurements.
The technical requirements for shielding and other safety with respect to patient radiation protection are foreseen in Chapter VI of the medical use of radiation.
The second paragraph:

The frequency of checks of safety equipment should be adapted to the rigors equipment exposed. Safety equipment used under varied / harsh conditions should be checked at least annually, while equipment used under stable conditions do not need to be checked as frequently. It should nevertheless not go longer than three years between each control.
Control of personal protective equipment in medical use of radiation should be checked annually. If the wear is small, however the controls performed more rarely. It should not be longer than three years between each control.
The need for periodic checks of safety should be part of the risk assessment to be carried out acc. requirement in § 17

To § 26:

Subsection
frequency of inspections of measuring equipment and other safety equipment should be adapted to the rigors equipment exposed. Measuring devices are used under diverse / harsh conditions should be checked at least annually, while equipment used under stable conditions do not need to be checked as frequently. It should nevertheless not go longer than three years between each control.
Fume hoods in isotope laboratories should be controlled in accordance with the relevant standards before they are used, the decor changes and then at least every three years. Relevant standards for control of fume cupboards in isotope is DS 457 (Danish standard) or equivalent standards.
The need for periodic inspections of measuring equipment and other safety equipment should be part of the risk assessment to be carried out acc. requirement in § 17

To § 29: Requirements for classification and labeling of workplace

Workplace containing radioactive sources shall be marked with the standard warning sign against ionizing radiation in accordance with Regulation 6 December 2011 No.. 1355 about organization, leadership and participation ch. 10.
Subsections:
Classification of interest is primarily based on the dosages that can be exceeded and not what doses workers on average subjected. Within controlled and monitored area, it may be work that is of such a nature that radiation exposure is less than 1 mSv per year, and predictable in the sense that the risk of accidents is negligible. Such tasks can also be performed by pregnant occupationally exposed, ref. § 30 where the dose limit for pregnant specified.
Third paragraph:
Activities must organize radiation use and shielding etc.. so that occupationally exposed workers are not exposed to more than 1 mSv per year outside controlled or supervised area. For employees who are not occupationally exposed, the agency shall organize radiation use and shielding etc.. so that these employees are not exposed to more than 0.25 mSv per. years, cf. § 6, third paragraph.
Fourth paragraph:
During transport outside the closed area is labeling requirements, radiation levels etc. specified in transport regulations, cf. The commentary to § 2, subsection c). Transport include in this context all operations and conditions associated with and involved in the movement of radioactive material, including caching along the way.

To § 30: Dose limits mm

Subsection:
Dose limits refers to the contribution beyond background levels of natural radiation.
By intake of radioactive substances, the same limit, ie the sum of the dose from the intake of radionuclides (internal dose) and dose from external sources should not exceed the specified limits. Derived values ​​in the form of annual intake limits (Bq / year) for various radioactive substances can be obtained from the Norwegian Radiation Protection Authority.

A)
limit applies by irradiation of all or large parts of the body, and relates to an effective dose.

C)
Huddosegrensen applies average dose to an area of ​​1 cm² wherever large area of ​​skin exposed.

Third paragraph:
To safeguard against exceeding the dose limit should establish action levels reach a certain fraction of the dose limit is exceeded. Proposed action levels for medical radiology's supervisor 5.
Any exceedances of the dose limit could be due to technical failure at strålingsapparatur but normally overrun due to failing education and unfortunate working techniques. Employer survey by exceeding the dose limits may mean for example:

-
Investigate of working techniques and procedures, especially if these have changed. Can distance to the radiation source / radiation field increased? An employee may be protected better?

-
Examining Instrument urine positions collimator, kV / mA etc., And see if these are optimized with regard to radiation protection. Is a direct error in the apparatus that may affect the radiation dose?


The employer should also investigate possible reasons that have nothing with work to do, such as whether personal dosimeter have been stored close to a radiation source, or that the employee has been to X-ray examination without taking off the dosimeter.
See also regulation of 6 December 2011 No.. 1357 on the performance of work, use of work equipment and associated technical requirements (regulations on the performance of work) Ch. 15 on ionizing radiation.

To § 32: Personal dosimetry

Subsection:
requirement implies that business must assess the need for personal dosimetry of different personnel. The assessment must be documented to the likely radiation exposure, residence in controlled or supervised area etc. Personal dosimetry is not required where årsdoser over 1 mSv can be excluded.
Radiation exposure is measured for example by means of a personal dosimeter, fingerdosimeter or different interndosimetriske measurements.
Subparagraph:
employer's obligation to inform the employees are fulfilled by the employer at least annually inform each employee in writing of the interrogated doses. Data on the individual exposure is sensitive health information and must be handled in accordance with the Personal Data Act.
Employers other duties regulated by the regulation of 6 December 2011 No.. 1357 on the performance of work, use of work equipment and associated technical requirements (regulations on the performance of work) Ch. 15 on ionizing radiation.

To § 33: Dose Reporting

Reporting at the individual level means that dose of each employee shall be stated in the report. Creation of a national dose registry is planned. Until the establishment of such a register should dose information must be reported without being personally identifiable.

To § 34: Limits etc. Exposure of people

At all exposure should be kept as low as is practicable means that take into account other factors; environment, aesthetics, cost, etc. while intentional advantage achieved. Upon placement of sources such as base stations for mobile phones, should the operator select the antenna locations that provide good coverage for mobile phones, while selected the option with the lowest possible exposure where people have long-term stay. For other systems, such as radar systems etc.., Should always choose the solution that delivers the lowest exposure, assuming other factors are taken into account.
When new buildings near existing high-voltage facilities or new facilities near buildings required an investigation by magnetic fields above 0.4 μT. The network owner or developer will then be obliged to consider alternative solutions against each other with respect to other factors mentioned above. Municipalities should be aware of magnetic field problems in the treatment of building permits, construction projects and land-use planning. Study requirement applies preferably for buildings where people, especially children, have long-term stay.
If the magnetic field is below 0.4 μT considered regulations to be met and further investigation or consideration of mitigation measures are unnecessary.
In line with the guidelines of the International Commission on Non-Ionizing Radiation (ICNIRP), the limit values ​​for electric field in some situations be exceeded, for example by brief exposure when passing under power lines. Work on energized power lines that can provide higher exposure than in policies, for example, could be carried out if this exists emergency, financial or practical need.
For electrical plant and equipment will also be shown to law of 20 May 2005 no. 28 on supervision of electrical installations and electrical equipment regulations. The purpose of the Act is to ensure that all electrical installations shall be constructed, operated and maintained so as not presents danger to life, health and property, cf. Act § 2. Businesses that own electrical high voltage systems should be able to provide information about magnetic fields in buildings or in areas with prolonged stays near its plants. The same applies to the operators of cellular networks and owners of other radiation sources that may involve exposure which may exceed the current limit.
References / standards:

-
ICNIRP (International Commission on Non-Ionizing Radiation Protection) its "Guidelines on limiting exposure two non-ionizing radiation," 7/99. Munich, 1999 and "Guidelines for limiting exposure two time-varying electric and magnetic fields (1 Hz to 100 kHz)." Health Physics 99 (6): 818-836; 2010.

To § 35: Use of IPL and strong non-ionizing sources

Subsection:
Intentional human exposure also includes cosmetic use, bio-stimulation and the like. Cosmetic use includes treatment that has purpose as skin appearance, wrinkle removal, removal of tattoos and the like.
The second paragraph:

Standards contain requirements for users and suppliers and precautionary projections by various applications.

To § 36: Technical requirements for solariums

Subsection:
Radiation quality requirements means that it must be documented that the measurements that underlie the classification is performed acc. current European standard for solariums and pipes.
Subparagraph:
tanning salons with operator must ensure that customers are at least 18 years. In unstaffed tanning salons is the owner obliged to inform about the ban clearly to their customers, at least by means of clearly visible spreads.
The ban is aimed at businesses, but also provides a legal basis for the regulatory authority to dismiss clients under 18 years.
From 1 January 2014, all offering solariums have competent service present. When this requirement is introduced must control sure to check customers' ages.
Fourth paragraph:
Lookup with warning text and safety rules shall include information on safer use and who risk considerations should not take solarium, ref. EN60335-2-27 section. 7-12.

To § 37: Eligibility

Medical use of radiation should do more good than harm to the patient. In order to address this to the legitimacy of medical use of radiation considered on three different levels.
Level 1 - general:
Use of radiation in medicine is found to be justified on a general level.
Subsection:
Level 2 - special:
It must be ensured that the chosen apparatus and method / procedure will improve the diagnosis or treatment or provide the necessary information about the exposed patient. The assessment must include direct advantages and disadvantages of selected apparatus and method, but may also include health, economic and other social issues.
Subparagraph:
Level 3 - individual:
The legitimacy of medical use of radiation should always be considered for the individual patient. The radiation used should be highly beneficial to the patient, i.e. the benefits exceed the damage that radiation can cause. The assessment should take account of expected diagnostic or treatment-related result. The assessment may also include the result's expected quality and efficiency, and the benefits and risks associated with alternative methods that involve less radiation doses, or that do not use ionizing radiation. The patient's "individual conditions" means the individual diagnosis, disease state, symptoms, age, sex etc. Individual eligibility shall be made before the patient is exposed to radiation.
The responsibility for initiating procedures for general eligibility assessments may be added to the one who has the overall responsibility for the business. Use of reference criteria and defined patient categories will be of great help in the eligibility process.
Level 2 and 3 in the eligibility assessment must be verified.

To § 38: Optimization

Subsection:
optimization is an ongoing process that should be integrated into business activities. The method is most optimal for that treatment should be applied. The optimization is usually an interdisciplinary process. Optimization involves an assessment where one out of technical, practical, economic and social conditions chooses apparatus and procedures such that:

-
Diagnostic examinations performed with the lowest possible risk or radiation dose, while a sufficient diagnostic information.

-
Examination or treatment of pregnant women with ionizing radiation results in the lowest possible radiation dose to the fetus.

-
It by radiotherapy sought adequate radiation dose to the target volume, while it sought to achieve the lowest possible dose to tissues outside the target volume. The target volume is defined finite volume in the patient where one contemplates an appropriate dose based on clinical objective of irradiation.

Subparagraph:
With procedures meant method books or procedure manuals. Revision of the procedures can be done by internal or external audits. Revisions must be documented in the report filed in the business. Clinical audits represent an alternative audit form, based on a structured peer collaboration led by clinicians. These undergo and compares practices and performance against internal procedures, possibly national and international standards.
It should not go more than two years between the revision of the procedure.

To § 39: Reference


Requirement implies that radiological examinations (incl. Health checks) can not be performed without a referral. The requirement for referral will help to ensure that the investigation and processing is justified in relation to the individual patient's premises, and means that refers must cooperate with executive doctor. The reference should be based on a clinical consultation of the patient and must contain sufficient information for the medically responsible (cfr. § 42) can evaluate the study entitlement. Referring to the institution may raise questions about the independence and legitimacy. Such self-referral should be used with caution. Reference to studies outside their own field is not in accordance with regulations intention. The referring a patient must have the skills to follow up reply to the survey. It is not allowed to let patients even "order" radiology.
With particular jet bothersome surveys mean, inter alia, angiography, gastrointestinal investigations and perfusjonsundersøkelser. The requirement of reference do not include research use of radiation.

To § 40: Representative doses / administered activity

The representative value of dose or activity meant business separate average value for a given survey in a given laboratory based on a sample of patients. These values ​​are an important tool for optimization studies, and will also be used for comparisons within the organization. In radiology are several methods to measure or calculate the radiation dose in nuclear medicine used Administered activity as a measure of radiation dose. Establishment of representative dose / activity is not limited to surveys by the national reference values, but should include all types of surveys (with the exception of pure extremity studies) with a certain volume, such as more than 20 investigations per year. The representative doses / activities should be reported to NRPA by request, ref. § 47.

To § 41: Women of childbearing potential

This paragraph deals with the investigations or treatments where the uterus is located in or near the primary radiation field.
By X-ray diagnostic examinations, the risk of fetal damage small and focus on radiation dose must not be an obstacle to life-threatening conditions studied.
X-ray examinations of pregnant women can be implemented without special measures if the pelvis is not covered by primary radiation field, including investigation of head, thorax, extremities, dental radiology and mammography. For CT thorax must be an individual assessment based on fetal size. Accidental exposure of the embryo / fetus is also referred to Note to § 19 about warning of possible embryo / fetal dose of 20 mGy.
Administration of radionuclides for diagnostic or treatment to women who are or may be pregnant should be avoided unless there are strong clinical indications for it. Nuclear medicine treating women who are pregnant must planned so that an embryo / fetus gets the lowest possible radiation dose.
The business should have procedures to exclude pregnancy of a patient, as well as procedures for following up any inadvertent fetal irradiation.

To § 42: Medical expertise

Medical expertise will ensure that investigations and treatments are justified and optimized based on the individual patient's premises, and that image data is interpreted correctly. The requirement that such expertise should be included in the business must be seen against this background, and the organizational affiliation and proximity to the patient must be such that these issues are dealt with.

C)
requirement that oncologist will be, can be addressed by the oncologist approves and signs the final requisition and approve treatment regimen. Doctors who are undergoing specialist training can by department chief physician assessment given the same rights.

I)
The requirement that a doctor must be included, can be addressed by a doctor are present in the vicinity of the place where processing takes place and can be drawn into the treatment within a maximum of one hour.

J)
requirement applies chiropractor within chiropractic and physical therapist in physiotherapy. The requirement that a physician, chiropractor or physiotherapist will be, can be addressed by enabling them to examine patient during the same day as the treatment is done.

To § 43: Training in radiation protection and radiation for medical purposes

Training must adapt to the tasks performed in terms of both content and scope. This ensures, among other things relevant personnel have updated expertise on the requirements of radiation protection Act and regulations, radiation protection in connection with the medical use of radiation, and the apparatus with respect to parameters affecting radiation dose and / or image quality.

The scope of training should be seen in the context of the complexity of the current use of radiation, and in the context of the requirement for formal qualifications to operate apparatus as specified in § 45. Doctors who use x-ray machine to guide the operation, intervention, endoscopy etc. must be trained so as to establish an understanding of the parameters that affect image quality and the radiation dose to the patient and staff. Training must include interest apparaturtekniske conditions as well as work technique (distance, apparaturgeometri more).
Within radiotherapy will training and further education is particularly important in connection with the procurement of new apparatus and the establishment of new treatments.
Documentation of training should be part of the internal control system / quality system, with information about the date, signature mm

To § 44: Expertise in medical physics

With scientific personnel usually understood physicist with three years of theoretical and practical specialization in medical physics, which at least one year in clinical practice. This paragraph means that the enterprise qualitatively and quantitatively have to consider the need for expertise in medical physics, from the amount and type of equipment used. As means for such an assessment appears eg. the current recommendations of the European Federation of Organisations for Medical Physics: Criteria for the staffing levels in a Medical Physics Department.
Scientific personnel in external radiation therapy should normally be permanently attached business.
By radiology and nuclear medicine requiring approval pursuant to § 8 shall such personnel included in the business of technical quality and the necessary consultation on matters that dose and image quality assessments mm in connection with the optimization of study protocols.
Scientific personnel certified by the Norwegian Association for Medical Physics is considered to meet the requirements of competence in the relevant modalities.
Medical physicist within MRI has an important task to carry out quality control, optimization of image quality and teaching in MRI safety.

To § 45: Competence to operate apparatus for medical use of radiation

The requirements for competence to operate apparatus is differentiated with respect to the apparatus complexity and risk to deliver higher doses of radiation than necessary due. misapplication. Apparatus for easy dentalradiografi can also be operated by authorized dental and dental hygienists, cf. General exemption granted by NRPA 20 March 2012.
Professionals serving apparatus specified in § 45 may use helper when helper given the necessary guidance and support. Any caregiver is performing tasks on health personnel responsibility and under its supervision. Health personnel in the business must be fully able to operate the apparatus, and examination / treatment must be part of health personnel normal business tasks. See also the Act of 2 July 1999 no. 64 relating to health personnel (Health) § 5.
fourth paragraph:
For flermodalitetsapparatur as PET / CT and SPECT / CT, the requirements of the CT competencies assessed against the complexity of CT -Using. Simple CT-use, such as for anatomical correction, can be performed by laboratory technicians with expertise in addition CT usage. Full featured diagnostic CT examination on flermodalitetsapparatur require radiographer education on an equal footing as normal CT (see first paragraph).
Fifth and sixth paragraphs:
With healthcare means authorized health with authorization according to the Health.

To § 46: Screening Commercial mm

A number of criteria must be met before the establishment of a screening program. The criteria are listed in the Directorate of Health websites. The criteria for compliance and policies developed by the World Health Organisation (WHO).
Exploration Program targeting asymptomatic groups set high standards for all stages of the imaging processing chain, since no prior clinical observations as a basis for image interpretation.
National health authorities are responsible for drawing up national guidelines for screening programs. It is illegal to offer screening activity that conflicts with national guidelines. Unsystematic surveys of healthy subjects did not meet requirements for systematic and thus can not be marketed as a screening program.

To § 48: quality control, etc. of apparatus

The second paragraph:

Claims for maintenance and quality control of jet medical apparatus also applies to devices subject to notification. Apparatus for medical use of radiation is controlled by current international recommendations, if there are no national recommendations on the site. The frequency of controls must be adapted to the equipment complexity and use rate. For advanced equipment will often be required quarterly controls, while annual inspections will be sufficient for less sophisticated equipment. See also § 21.
fourth paragraph:
Quality control includes both receiving, status and constancy. Preparation and initial inspection must be performed before the new apparatus put into clinical use, and establish baseline values ​​for later status checks. When changing apparatus technical matters or related peripherals that are likely to affect output values ​​shall establish new values. These values ​​are followed over time (annual status checks) and there must be procedures for action by the observed discrepancies. The tolerances for deviation routed so that errors or incorrect use of apparatus and equipment captured before it affects the clinical outcome of the examination or treatment. The frequency of constancy will depend on the type of equipment and varies from daily, weekly and monthly checks to ensure that the apparatus is working properly.

To § 49: Dosimetry by ionizing radiation, radiology and nuclear medicine

Subsection:
With dosimetry means the theory and application of principles and techniques for measuring and calculating the dose of ionizing radiation. With calibration means the establishment of the relationship between the relative size of a measuring instrument and a known unit of measurement in the SI system. For reference instruments for dosimetry (ionisasjonskamre) will have the calibration coefficient for dose in gray per charge in coulomb (Gy / C). Protocol "Absorbed dose determination in external beam radiotherapy TRS 398" from the International Atomic Energy Agency (IAEA), the Norwegian protocol for calibration of radiation sources for external treatment, "IAEA TecDoc 1274" for brachytherapy and IAEA Technical reports series no. 457 "Dosimetry in Diagnostic Radiology: An International Code of Practice 'for radiology.
Subparagraph:
Every other year considered regular calibration frequency within radiology and nuclear medicine. Reference Instruments used for such calibration must be traceable to relevant national standards.

To § 50: Radiology medical

Subsection:
In conventional radiography and fluoroscopy dose will typically be given as input dose at the skin surface or dose-area product. By computer-assisted sectional imaging (CT), the dose can be given as volume CT dose index (CTDIvol) and dose-length product (DLP). From such dosage values ​​may also organ doses and effective dose calculated using the available software. The requirement for individual dose registration has its origin in the patient is entitled to information about the radiation doses received. Such individual dose registrations should be reviewed regularly with a view to identifying high patient doses and optimization studies, and records should be made electronically in such a way that the information is easily possible to extract for further processing and assembly. Individual dose values ​​must be obtained for reporting to NRPA by request, ref. § 47.
Third paragraph:
general all doses be kept as low as practicable in accordance with the principles of justification and optimization. Within radiology is nevertheless some particularly radiosensitive organs mentioned, where shielding of organs should be considered if this does not cover the areas of clinical interest. Special measures or use of screening equipment to reduce the radiation dose to radiosensitive organs should be stated in the protocols.

To § 51: Ionizing radiation

Subparagraph:
With professional responsibility means function held by someone with expertise described, and which in its field has academic responsibility for justification, optimization and working and cooperating with academic responsibility for other areas or specialties in the assessment of clinical outcome.
Third paragraph:
provision describes the requirement for a register for deviation in radiotherapy. Categorization of deviations and treating these in interdisciplinary forum, makes it possible to detect mistakes and learn from events. The categorization of discrepancy include, among others assessment of severity. In § 19 f) s requirement that substantial deviations shall be sent to the Norwegian Radiation Protection. The business is expected to have a procedure that describes how an undertaking the assessment of such a difference, and which of these variances that are classified to be sent out of the clinic, the NRPA.
Fifth paragraph:

With brachytherapy meant intracavitary, intravascular and interstitial therapy with sealed radioactive sources, as well as treatment with øyeapplikatorer.

To § 52: Nuclear Medicine

Subparagraph:
The individual dose planning in nuclear medicine means that it must be taken into account age, sex, weight, disease state, etc. for in advance to estimate dose to the treated tissue.

To § 53: Treatment with non-ionizing sources

Methods shall be based on scientific reports, consensus reports or other independent assessments, and not only those published by the device manufacturer.

To § 54: Supervision

This provision expands the Radiation Protection Act § 18 on supervision and resolution. Norwegian Radiation Protection Authority is authorized to take the necessary decisions arising from the Radiation Protection Act § 19 to § 23 Requirements of the Law of 10 February 1967 relating to procedure in administrative matters (Public Administration), will apply to the decisions taken.
Fourth paragraph:
provision means that municipalities, in addition to the Norwegian Radiation Protection supervises solariums acc. Radiation Act and Radiation Protection Regulations. Municipalities are authorized to use the Radiation Protection Act, Chapter V of decisions, means and sanctions regulations.
Municipalities delegated supervisory authority under the Radiation Protection Act must be seen in conjunction with the municipality's responsibility to supervise "those factors and environmental conditions at any time directly or indirectly may affect health" by public health § 9. Local Authorities supervising environmental health by public health law is overlapping with municipalities delegated supervision by the radiation Protection Act. Municipalities will include overseeing the radon concentration in air, under Regulations 25 April 2003 No.. 486 about environmental health § 7 and § 10a and regulations on 1 December 1995 no. 928 on environmental health in schools and kindergartens § 19. Municipalities will also supervise the hygienic conditions in tanning salons under regulations 6 may 1998 no. 581 on hygiene requirements for hairdressing, skincare, tattooing and ear piercing businesses etc.
NRPA and municipal authorities can conduct unannounced inspections.
Businesses may be required to cover the cost of supervision arising out of a violation ref. Radiation Protection Act § 18 fourth paragraph.

To § 55: Exemption

Provision is regarded as an emergency steam, and it is assumed that it is used with great caution.