FEDERAL INFORMATION

Regulation of radiation safety guarantee

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Atomic Energy Law Base June 03, 2008;

Base of Protocol 07 /2010/NĐ-CP 25 January 2010 of the Government regulates the details and guidelines for the implementation of some of the provisions of the Atomic Energy Law;

Base of Protocol 20 /2013/ND-CP 26 February 2013 of the Government stipulated the functions, duties, powers, and organizational structure of the Ministry of Science and Technology;

Base of Protocol 63 /2012/NĐ-CP August 31, 2012 of the Government stipulated the function, mandate, jurisdiction and organizational structure of the Ministry of Health;

The Minister of Science and Technology and Minister of Health Department of Health issued a regulatory of regulations on the safety of radiation safety in health care.

Chapter I

GENERAL REGULATION

What? 1. The tuning range and subject apply

1. This federated information regulates radiation safety requirements for radiation devices, radiation sources, radiotherapy used in health and equipment used in nuclear medicine; requirements for radiation equipment, rooms working with sources of radiation, radiation, and radiation therapy. radioactivity and radiation drugs, radiation therapy patients with radiation (taking radiation medication or radiation-based implants) and storage for radioactive sources or radioactive waste; required for installation, operation of radiation equipment; request for radiation control. occupational, public screenings and medical screenings; the requirement for the application of the radiation breakdown and accountability of the organization, the individual involved in security assurance. It ' s all radiation in medicine.

2. This joint venture capital applies to the basis of the disease, healing, scientific research, training, prevarable medicine and pharmaceutical testing (later known as the medical facility) that uses radiation equipment, radiation sources, radiation drugs, and equipment used in the area. in nuclear medicine.

3. This joint venture capital is not applicable to the radiation work produced by cyclotron radiation.

What? 2. Explain the word

In this Relevant Information, the words below are understood as follows:

1. Medical Projection is the impact of ionizing radiation on the following subjects:

a) The person who is sick to perform a diagnosis or treatment of the disease;

b) People are tested or monitored health;

c) Volunteers to participate in biomedical research;

d) Volunteers help, take care of the sick (that is not their profession) when the person is diagnosed or treated with ionizing radiation.

2. The level of instructions in medical radiation is the recommended value of doses, doses, or radioactivity that are used in reference to medical screening control, and when conducting work in practice, if these values are exceeded or are much lower then need consideration, reassessment to achieve the value of radiation. It ' s a reasonable level of medical radiation.

3. Head of medical facility is either the owner or the representative under the law of the owner or the authorized person of the representative under the law to manage the medical facility.

4. Medical radiation worker. Doctors, nurses, nurses, nurses, pharmacists, pharmacists, nurses, engineers, technicians, households, and medical facilities, working directly with radiation devices or other sources of radiation, open radiation, or taking care of the ill-treated patients. Radiation or must work in the area with potential radiation with a dose greater than 1 mSv/year or in the area at risk of radioactive contamination.

5. Radiation Device is stated in this Relevant Information as X-ray devices or devices that contain the source of radiation used in medical care to diagnose and treat the disease, including: X-ray equipment diagnostic in medical, diagnostic imaging devices using radioactive sources, The radiation device.

6. X-optical devices for medical diagnosis is X-ray devices used to screen, diagnostic imaging, including: X-ray devices (panoramic dental imaging devices, skull capture devices, film-based dental imaging devices), X-ray devices, X-ray devices, X-ray devices, and so on. Mobile, X-ray equipment, bone density, projection device, X-ray imaging, light-light X-ray device, CT scanner-based imaging device, X-ray device, and angiography.

7. Radiation Device is the ionized radiation emission devices used in medical treatment to treat cancer, including the X-ray device, the linear accelerator, the remote radiotherapy device, the HDR high-dose radiation pressure, the gamma knife device.

8. The device used in nuclear medicine is the gamma camera, SPECT, SPECCT/CT, PET, PET/CT, the radiometer of radiation therapy, the radiometer that measures the radiation in the body (the dialysis, the radiometer).

What? 3 The general principle of the safety of radiation in health care.

1. Organization, individuals who conduct radiation work using radiation equipment, radiation sources, radiation drugs in the medical facility must be reassuring:

a) The designation of the examination, the treatment of ionizing radiation, is that the actual benefit of the disease is significant compared to the harm that they suffered;

b) Not for the dose of radiation caused by these tasks to the medical radiation staff and the public to exceed the limiting dose; guarantee the dose of radiation to the person according to the instructions level;

c) Keep the dose of radiation to the patient, the medical radiation worker, the public and the number of people with radiation at the lowest level that can be achieved in a reasonable way.

2. Only conduct examination activities, healing, scientific research, training, prevarable health care and pharmaceutical testing using radiation equipment, radiation sources, radiation drugs when licensed by the state regulator, licensed by the state authority to conduct public conduct. The radiation.

Chapter II

THE SAFETY OF RADIATION IS REQUIRED.

What? 4 . The general requirement for safety guarantees for radiation equipment, equipment used in nuclear medicine, is also available.

1. Radiation devices that use for diagnosis, disease treatment, and devices used in nuclear medicine must have a quality certificate for the type or type of equipment (type or model) that indicates compliance with safety assurance requirements according to the standard of the disease. of the International Commission of Electrical Engineering (IEC), the International Organization for Standarization (ISO) or the equivalent national standards.

2. There are documentation accompanying the device, including documentation of the device's specifications, operational guidance, and maintenance, safety guidelines. Operational documentation, the safety guide must be translated into Vietnamese.

3. Executive instructions or abbreviation and operating values on the control board of the radiation device must be in Vietnamese or by language in accordance with the language that the operator uses.

4. Radiation devices must have radiation-beam control mechanisms that indicate and trust the "disconnected" or "open" beam.

5. The radiation device must have the mechanism for the beam shelter for the purpose of controlling the beam pointing to the body area the patient needs to diagnose or treat.

6. The radiation field that radiated in the area to diagnose or treat on the patient must be uniform and the degree of unco of the radiation field must be specified by the vendor.

What? 5 The safety requirement for the X-ray device is diagnostic in health care.

The X-optical device diagnos in medicine in addition to the implementation of the requirement by regulation at Article 4 of this federation must ensure the following requirements:

1. The radiation level of the X-ray output is not exceeding the 1mGy/hour at a 1m distance from the tip of the UV light balloon to the average on an area that does not exceed 100 cm ² for every work mode of the device recommended by the manufacturer.

2. The fixed filter value of the X-optical system in the comparable alumina alumina (mm Al) must be specified on the shadow container casing.

3. Have a beam-beam size test, minus the device.
The x-photoshoot uses the film after the tooth hole and the X-ray device.

4. Voltage Voltage Parameters (kV), ball stream (mA), ray generation time (s) or a ray generation constant (mAs) must be displayed on the controller in order to set the work mode and when taken.

5. For the X-ray device, the release of the ray must be terminated after a pre-order period or after reaching the pre-order mAs or the pre-order radiation dose value.

6. For the X-ray device the projector has to have an AEC beam automatic control controller or a touch-and-hold-to-hold control switch, which ensures a beam-only device if the switch is pressed, tightly held, and will stop broadcasting when releasing the switch.

7. The mobile X-optical device must have a wired cable long enough to secure the distance between the device operator and the 2 m minimum ball. For the other radiation device, the minimum distance is 3 m.

8. The X-optic device must have the lead rubber shield-mounted shield panels to shield the radiation rays affecting staff and the shield-hanging shield on the ceiling for use for the purpose of protecting the eye and the employee ' s thyroid while tracking people. Sick. The lead rubber covers must ensure that the shield is not less than 0.5 millimeters of the equivalent lead.

What? 6 Requesting safety for the radiation device.

The external radiation device that imples a request by regulation at Article 4 of this federation must ensure the following requirements:

1. Allow stop to stop the radiation from the console and the reradiation after a stop can be made only from the console; automatically returns the source of protection when the power outage and hold the source at that protection position until the device is enabled to restart from the console. Console.

2. The radiotherapy devices that use the radioactive source must have at least 2 (two) the control structure that allows for the self-resourcing of the safe location and termination of radiation when there is incident.

3. Remote radiation-based radiotherapy devices and high-dose (HDR) radiation-pressure devices must be designed to be able to manipulate hand-based operations as a source of protection in case of an emergency. Gamma-ray devices must have a mechanism for manipulations of a window to close the source in case of an emergency.

4. The source box of the remote radiotherapy device using a radioactive source and a radioactive source of high-dose pressure-pressure (HDR) radiation must have the correct standard of radiation warning signs that can be clearly visible and difficult to blur.

What? 7 Safety requirements for radiative radiation and radiation.

1. The enclosed radioactive sources used for long-term radiotherapy or high-dose radiation therapy devices must comply with the international standard ISO 2919:2012 Radiation protection-Sealed radioactive sources-General requirements and classification. the country TCVN 6853:2001- Radiation safety-closed source of radiation-General Demand and classification And if it continues to be used after the usage period is recommended by the manufacturer to be tested for radioactive leaks to confirm the source remains intact as a design.

2. The radiotherapy used in nuclear medicine must be allowed to be legally permitted in Vietnam by the rule of law on pharmacy, which is used only for the purpose of prevention, healing, body function adjustments and must comply with international standards already under the law. admitted to the following parameters:

a) radioactive nuclear purity (which is the percentage of radioactivity of radioactive nuclei marked in radiotherapy compared to the total activity of radioactive nuclei present in radioactive drugs);

b) Private activity (is radioactive activity on a unit of the marking compound of a specific radioactive nucleus for both the inner form and not in the marking compound of that radioactive nucleus);

c) The radioactive purity of radiation (is the percentage of the radioactivity in the form of the desired chemical bond of the markup compound compared to the radioactive nucleus present in the radioactive drug, meaning that the concern for the radioactive nucleus is separated from the marking compound);

d) Chemical purity (which is the ratio of the primary marking compound not interested in radioactive activity is in it compared to the entire radiotherapy preparation. The radioactive drug is the preparation of the preparation for the disease to be used for the disease.

MH;

e) The parameters required for medicines in accordance with the law of pharmacology.

3. All radioactive drugs must be labeled with a label stating the following information:

a) The radioactivity; the chemical form (the drug name and the chemical formula);

b) The total radioactivity of the product;

c) The date of radiation activity;

d) The results of the measurement of radioactive chemical impurity;

The name, the address of the manufacturer and the date of production;

e) The expiration date;

g) Number of batch or batch produced;

h) The volume of the radiotherapy (case in solution form);

i) Other information on the label as prescribed by the law of pharmacy.

What? 8 . Safe requirements for radiation, equipment, and radiation safety protection equipment.

1. The medical facility has a long-distance, radiation-based radiotherapy device equipped with a radiation-dose measurement device. The medical facility that uses radioactive drugs (nuclear facilities) must be equipped with radiation-dose measurement devices, the surface contamination of surface contamination with a measured energy band that is consistent with the type of radiation released from the radiation device and the source of radiation used at the facility to regularly. measurement of environmental radiation testing, radiation contamination, and radiation control when entering the area of radioactive sources.

2. The nuclear medicine facility must equip the following radiation safety protection equipment and equipment:

a) The smoking cabinet is able to integrate and save the appropriate suction to phase, the dose of radioactive medicine;

b) The table for the preparation, the dose of radioactive drugs with lead shield combined with the screen of the L-shaped beta radiation and the lead glass view;

c) The arm, the source pin to manipulate with the remote source of radiation;

d) Normal radiation medicine has lead shield and outer shell coating against rupts;

Khay is specially designed for preparation, a dose of liquid radioactive medicine;

e) Xilhe has lead shielding designed specifically for use in nuclear medicine;

g) The pippet automatically uses once;

h) tools for disposal of the dumped radioactive substance.

3. The medical facility that uses a radioactive source in the radiation therapy must equip the following radiation safety protection equipment and equipment:

a) The table for the operation with the radioactive source with the L lead shield and lead glass view;

b) The instruments of the source, and the source of the hand with a strong hand;

c) The source cabinet has different comers to contain different sources of activity;

d) Bìn the source for transport.

What? 9 . Control and calibration of radiation equipment, radiation measurement devices.

1. The medical facility must perform the control over the radiation equipment used at the facility itself as follows:

a) Before you put it in use for the first time;

b) periodically a one-year term for the radiotherapy device, computer-based CT scanner device, X-ray device, and a two-year term periodically for diagnostic X-ray devices in other health since the date of the use;

c) After the installation or repair of the device;

d) The radioactivity device is in addition to the execution of regulation at points a, b, and this clause must carry out the dose-based dose calibration test according to the recommended manufacturer.

2. If the test results show that the operating parameters related to the safety of the radiation device deviated from the permitted value, the device must the new calibration be allowed to continue to use; the inspection, the test must be carried out according to the procedure. produce or according to the respective national standards.

3. The radiometer (radiation-dose measurement device, surface contamination measurement device, radiative dose measurement machine) must be initially fixed, after repairs and periodic periodic repairs.

4. The calibration, radiation equipment calibration and radiation measurement equipment must be performed by the organization, the individual is registered by the Ministry of Science and Technology, the calibration service, calibrated.

What? 10 . In the firing of radiation equipment, a working room with radioactive sources and radiation drugs, the repository holds radioactive sources or radioactive waste, the patient ' s storage room for radiation therapy.

1. The firing of the radiation equipment, the working room with radioactive sources and radiation drugs, the storage source for radiation or radioactive waste and the patient ' s radiation prevention is not immediately ordered adjacent to the department, the pediatric department.

2. The set of radiation equipment must guarantee the size of the prescribed size at Annex I issued with this Relevant Information.

3. The protective thickness of the walls, floors, ceilings, doors to the radiated device room, the control room ' s observation door must be calculated according to regulation at Article 7 Digital. 19 /2012/TT-BKHCN November 18, 2012 of the Minister of Science and Technology Regulation on Control and Safety Security in occupational radiation and public screenings and must ensure the potential radiation dose of the working environment in practice (not counting the automatic radiation) of the environment. As follows:

a) In the control room or where the control cabinet of the radiation device does not exceed 20 mSv/years;

b) All positions outside the room set the radiotherapy equipment where the public goes back, where the sick person waits not to exceed 1 mSv/year;

c) In the control room or where the controller controller of the X-optical device diagnosis in medical (except for the X-ray device) does not exceed 10 µ Sv/hour.

d) All positions outside the room set the X-ray apparatus for medical diagnosis where the public travel, the person sitting waiting and the surrounding workrooms does not exceed 0.5 µ Sv/hour.

The case of a diagnostic of the X-optical device in health is located in a residential area, adjacent to the housing or workplace, which ensures the dose of radiation at all points outside the room in the room of the device with the natural radiation.

4. Remote radiation prevention design, high-dose radiation therapy outside the radiation shield requirements must have a dynamic locking system for the door to the room to ensure only the launch of the radioactivity device when the exit door is closed and automatically terminated the projection. When the door is open unexpectedly; there is a radiation warning system and at least one emergency stop-off system is installed in the room.

5. The design of the radiotherapy room must be determined by the Department of Radiation Safety and Nuclear, issuing a license to conduct radiation before construction by regulation at Digital Information. 08 /2010/TT-BKHCN July 22, 2010, of the Minister of Science and Technology, instructs the declaration, licensing the radiation work and the certificate of radiation personnel.

6. The nuclear medicine facility must have a protective room and work with radiation drugs, room for the person to drink or inject radiation, the storage room for radioactive waste, the private bathroom for the sick person who has taken radioactive drugs, the equipment department said. gamma camera, a patient storage room if there is treatment for the thyroid disease or thyroid cancer, the bathroom area, the employee ' s wash after working on contact with the radiation medication. These rooms and areas must be designed to protect anti-radiation and anti-radiation contamination, namely the following:

a) Must be calculated to shield the radiation so that the radiation risk where the public goes, the patient is waiting, the surrounding workrooms don't exceed 0.5 µ S/ hours.

b) The floor and wall of rooms at risk of radioactive contamination must be covered with smooth, waterproof materials, easily deterred;

c) The washing of employees after the operation with radioactive drugs must be fitted with an automatic shower system or a wash-free shower to open water by foot or elbow;

d) The entire radioactive contamination of radioactive material must be collected by a separate drainage pathway into the liquid radioactive waste disposal tank.

7. The Radiation Equipment Room, a working room with radioactive sources and radiation drugs, the patient ' s bedroom that drinks radiation drugs in nuclear medicine or the radiation of radiation in the radiation therapy, the radiation equipment control room must be classified as a region. control and must apply the following measures:

a) Set at the top of the door into the area that controls a pattern of radiation under the prescribed pattern at Annex II issued with this Conventional Collusion.

b) Set up a signal beacon at the doors to the radiation device room, the radiation-based radiation department, the radiation processing room, and the maintenance of the beacon light during the course of the radiation;

c) Attached Safely at the door to the control area;

d) For long-distance radiation prevention, high-dose pressure radiation radiation, a patient storage room for radiation medication or a radiation source transplant must use additional access prevention measures including a barrier, door lock, or a direct monitoring officer.

8. The archive that holds the radioactive source or storage of radioactive waste must be designed and applied the controls as follows:

a) Make sure that the radiation dose at every location on the side of the warehouse wall does not exceed 0.5 µ Sv/now;

b) Set the maritime radiation warning signs at Appendix II issued with this same link at the door to the warehouse and wall outside the adjacent area of the area.

c) Apply the monitoring measure, preventing the person from disentering the warehouse.

What? 11 Installation of radiation device

The installation of the radiation device must ensure the following requirements:

1. Each room is only fitted with a radiation device, except for the diagnostic X-ray device in medical that allows the deployment of 2 devices in one room but must ensure only one device is operated at a time.

2. The radiated device is installed to ensure when using a beam of rays that does not navigate into the control cabinet, entry door, window or public area.

3. The radiators that control the radiation must be located outside, the device is located, and there must be a means of observing the sick, there is a means of information between the operator and the sick. Where X-optical device diagnos work at the voltage is less than 150 kV, the controller is allowed to be placed in the device room but must have a lead vessel covering the level of the radiation at the location of the device staff operating less than 10 µ SSv/hours.

What? 12 The integrity of the radiation and the safety of radiation equipment.

1. The medical facility must build the work process with the radiation device, the radiation source, the radiation safety cabinet that ensures the following requirements:

a) The working process needs to specify the steps of conducting work in the operation of radiation equipment, working with the source of radiation, working in the area at risk of radiation or radiation contamination, taking care of the person who drank radiation drugs or implantation. radiation; the operation process for each device, regimen treatment for each type of disease;

b) The radiation safety content must specify the radiation safety requirements for medical radiation personnel, other employees in the medical facility, the sick, the careerer, or the aid of the sick and the public.

2. The radiation device operator must take a serious implementation of the work conduct:

a) Check the device safety before starting and after the end of the work;

b) Close the door during the operation of the device;

c) Compliance with the operation of the device;

d) Attention the abnormal signals of radiation equipment and test equipment to timely detection of incidents, prevent accidents;

Not to remove the damaged parts of the device's protective system and to operate, for example, to close the door-lock system into the radiotherapy room.

What? 13 Use the labourers to do the radiation.

1. The medical facility is responsible for the layout so that the medical radiation worker is a female worker who does not involve radiation during the time they are pregnant or having a child under 12 months of age.

2. The medical facility is not used to use people under the age of 18, who suffers from radioactive taboos to operate radiation devices, working with radioactive sources, taking care of the sick person treated with radioactive isotopes or having to work in the laterary area. The risk of radiation with a dose greater than 1 mSv/year or in the area is at risk of radioactive contamination.

3. The medical facility has apprenticed learners, practitioners, students who practice radiation equipment, working with radioactive sources, taking care of the sick person treated with radiation or radiation drugs, working in the potential area of radiation that is at risk of radiation with radiation. dose levels greater than 1 mSv/year or in the area at risk of responsible radioactive contamination:

a) The training organization for the subjects stated on the basic requirements of radiation safety, the interiors, the radiation safety regulation of the facility; and the following:

b) The professional cadres of instruction, tracking, monitoring during the course of the work;

c) Apply dose control measures to ensure the radiation dose of these objects does not exceed the prescribed dose limit at the Appendix I of the Digital Information Digital Information. 19 /2012/TT-BKHCN November 18, 2012 of the Ministry of Science and Technology of the Ministry of Science and Technology provides for the safety of radiation in occupational radiation and public radiation.

What? 14 Training radiation safety

The medical facility is responsible for the training of radiation safety for the medical radiation staff, namely the following:

1. The organization of radiation safety training for new medical radiation workers recruits under the basic radiation safety training program provided by the Ministry of Science and Technology.

2. periodically at least 03 years of training to repeat and add in-depth knowledge, new information on radiation safety for medical radiation personnel.

3. Every year, the training organization for medical radiation agents in the radiation safety inpatient, the regulation of the facility concerning radiation safety assurance, the process of the application of radiation incidents, or the dissemation of new regulations, new information on the safety of radiation safety.

4. Make sure that the training of radiation safety regulations in Clause 1 and 2 This is done by the organization, the individual has the registration of the radiation safety training service provided by the Ministry of Science and Technology.

5. Set up, update and save the training records, radiation safety training.

What? 15 -Control of the area.

1. The medical facility must conduct a measurement of the environment in accordance with the following regulations:

a) The measurement of the work environment (s) and the verification of the investigation levels when the filing of a permit issued a license to conduct the radiation work;

b) A yearly periodic examination of radiation levels at the positions of medical radiation personnel working, the level of environmental radiation at the entrance of the door and the area around the storage devices, where the source of radiation, the radioactive waste;

c) A monthly period of testing of radioactive contamination in the workplace and surrounding environment for a nuclear medical facility using radiation and treatment;

d) Comparison of the results of the environmental measurement working with the investigation levels that have been established and determine the cause, which applies the remedied measures in case the test results are greater than the investigation level.

2. The medical facility must establish, store the results of the results of the measurement of the work environment, and inform the results of the measurement of the environmental radiation that works for the medical radiation staff.

What? 16 -Track and review the radiation dose

1. The medical facility must perform the monitoring and evaluation of the individual radiation dose for the medical radiation staff, namely the following:

a) A personal risk site for medical radiation workers and the practice of measuring individual radiation evaluation for medical radiation workers at least every 3 months at the facility issued by the Ministry of Science and Technology, which operates a personal dose of radiation measurement;

b) A dose of total personal radiation dose for medical radiation agents working in contact with an open source of radiation (radioactive drugs, radiation contamination, radioactive waste), the sum of the external dose (according to the assessment results by a personal dose). to) and the dose shown in (by measuring the direct assessment or assessment based on the results of tracking the work map where working, the concentration of radiation in the air where work, the level of contamination of the contamination of the work and the work time, the work process);

c) The facility uses X-ray imaging devices, which must equip each person to work directly in the device room (staff operator, doctor, technician, nursing, nursing) 02 personal doses, a dose worn inside an apron. Lead-based lead rubber and a dose worn outside the lead rubber apron in the neck to accurately assess the risk of personal radiation for these objects in the formula:

Effective dose = 0.5 H _W + 0.025 H _N

In there, H. _W is the result of a dose-based reading in the apron of lead rubber.

Oh. _N is the result of the rash reading outside the lead rubber apron.

d) If the effective dose measurement results are due to the operator operator X-optical detection in health and radiation equipment or the resulting risk assessment result (including external projection and projection in) for the medical radiation worker. There is an exposure to the open source of radiation (radioactive drugs, radioactive contamination, radioactive waste) greater than the established investigation, must proceed to review the work process, the radiation protection measures and the remedied measures;

Guide and test to ensure that medical radiation personnel wear personal doses, personal risk preservation when not used in accordance with the instructions of the unit providing a personal dose measurement service;

e) The case of medical radiation workers deacrates individual or personal risks of failure to equip a new personal risk and conduct an assessment of that employee ' s radiation dose during the period of non-dose-based employment. to do the actual work, or according to the standard amount, in the same period of the previous measurements;

g) The results of the results of the results of a dose of personal radiation for medical radiation personnel;

h) Set, save and manage Personal radiation dose records for medical radiation personnel by regulation at Article 17 Digital radiation 19 /2012/TT-BKHCN August 8, 2012, of the Ministry of Science and Technology of the Ministry of Science and Technology for the control and safety of radiation in their professional radiation and public screening.

2. The case of medical radiation workers while working for various medical facilities, each medical facility must perform the monitoring, assess the individual radiation dose to the person in accordance with the regulation at Clause 1 This is a separate way to do so. The radiation work at that facility; the medical radiation worker must guarantee the total dose of the occupational radiation from the radiation work at all the facilities that they work does not exceed the occupational risk limit on the prescribed radiation staff at Annex I. number 19 /2012/TT-BKHCN August 8, 2012, of the Ministry of Science and Technology of the Ministry of Science and Technology for the control and safety of radiation in their professional radiation and public screening.

What? 17 -Personal protection.

The medical facility must provide sufficient protection equipment and protection equipment to medical radiation personnel, namely:

1. The lead rubber apron for the operator operator X-optical imaging device, the X-ray device, the projection device, the X-photosynthesis, the X-ray device, the television light-accelerated device, the CT Scanner computiation device.

2. The lead rubber apron, the rubber sheet covering the thyroid gland for the mobile X-ray device operator.

3. The lead rubber apron, the lead rubber sheet covering the thyroid, lead glass, the lead rubber gloves for the operator of the X-ray device, the doctor, the employee who works in the X-optical devices room, and the angiography.

4. Labor protection clothing, gloves, hood, jewelry, protective shoes, or gloves for medical radiation staff working exposure to open source of radiation (radioactive drugs, radioactive contamination, radioactive waste).

5. Lead the lead shield to the staff when exposed to the patient who has used radioactive drugs or has transplanted the source of radiation.

What? 18 Find health for the medical radiation staff.

1. periodically, the medical facility must organize a health examination for the prescribed medical radiation staff at the U.S. Digital Information Service. 19 /2011/TT-BYT June 6, 2011 of the Minister of Health for the management of labor sanitation, occupational diseases, occupational health care, organization of occupational diseases.

2. The medical facility is responsible for the layout so that the medical radiation staff does not guarantee the health requirement under the conversion of another job that does not come into contact with radiation.

3. The medical facility must establish, store and manage the health examination records of the medical radiation staff by regulation at Article 17 Digital Notice of Health. 19 /2012/TT-BKHCN August 8, 2012, of the Ministry of Science and Technology of the Ministry of Science and Technology for the control and safety of radiation in their professional radiation and public screening.

What? 19 Check, internal surveillance.

1. The medical facility must build a plan and organize inspection, internal monitoring of the implementation of the regulations, radiation safety content, the work process.

2. The medical facility has to make sure that every shortstop in the radiation safety management detected through the examination is reviewed and remedied.

3. The annual periodic, the medical facility must conduct a review of the content related to the radiation safety management of the facility by regulation at Article 18 Digital Information (s). 19 /2012/TT-BKHCN August 8, 2012, of the Ministry of Science and Technology of the Ministry of Science and Technology for the control and safety of radiation in their professional radiation and public screening.

4. The results of the test, internal monitoring must be established and stored in the radiation safety profile.

What? 20 -Medical radiation control.

1. The treatment doctor is responsible for ensuring the safety of radiation for the sick, responsible:

a) Specify the diagnosis, treating the person with ionizing radiation when it is certain that the benefit of the sick is significant compared to the harm that they suffered;

b) When there are two diagnostic or treatment methods together, the same result does not specify a ionizing radiation method;

c) There is a special consideration when given the diagnosis of diagnosis, treatment with ionizing radiation on children, women of birth age, pregnant women or during raising children under 12 months of age, namely:

-Ask the sick person and check to make sure they are not pregnant or not during breastfeeding under 12 months of age (in the case of the designation of the use of radiation medication) before the diagnosis or treatment is specified;

-Avoid the designation of ionizing radiation to examine, cure for pregnant women or pregnant or in time raising children under 12 months of age (the case of a radiation medication) unless an obligate clinical designation is required. The case of clinical designation is required to inform the medical staff, the operator of the device known for appropriate protection for the sick;

-Only radiation medication to examine, cure the child when the clinical designation is required and must decrease the specified radiation activity.

d) Reference the previous examination to avoid additional examination if it is not necessary;

Specify a radiation level, the dose of radiation medication used at a minimum but sufficient to achieve the purpose of treating the disease on the basis of instructions in the medical screening at Appendix III accompanied by this Passport.

2. Health workers, radiation equipment operating staff have a responsibility to ensure the safety of radiation for the sick when performing their work as follows:

a) To ensure that all medical emissions are performed only when the treatment of the doctor's treatment is carried out in accordance with the treatment of the physician;

b) Ensure that the device is used as appropriate.

3. The operator operator X-optical medical diagnosis in addition to the general responsibility requirements for the protection of the patient in paragraph 2 This must take measures to protect the person as follows:

a) Must ensure that the execution of the device operation process has been established;

b) Use the mechanism of a beam shelter in a suitable way to produce a minimum dose of projection on the pathogen but still has the quality of the image consistent with the requirement for the diagnosis in X-ray screenings;

c) Does not radiate into the radioactive sensitive body parts of the pathology such as the genitals, eye crystals, mammals, the thyroid gland and must use suitable shifage measures for the disease when it is inescapable;

d) Avoid screening, abdominal scans and pelvic areas of pregnant women or suspected pregnancies when there is mandatory clinical reason and need to apply measures to limit the smallest dose caused by child to do so;

Not for the sick and the person who does not have a stand in the screening room, taking an X-ray while doing a screening, taking the other person.

4. Medical personnel, the operator of the radiation device, which requires a general responsibility for the protection of the patient at paragraph 2 This must apply the measure to the dose of radiation on healthy tissues at the lowest possible level, consistent with the required dose level to reach the target. The target is in radiation.

5. Medical personnel, radiologist surgeon in nuclear medicine must guarantee the correct radiation dose at the doctor ' s designation.

6. The medical facility uses radioactive drugs to treat if the infected person has used radioactive drugs to ensure each room only saves one person. The case is forced by many patients to be in the same room, using mobile lead vessels to mask the disease to prevent the disease from being affected by the disease.

7. The medical facility must set up its own quality assurance program for medical screenings covering the contents:

a) Secure the radiation devices, the radiative dose standard gauge must be specified, the correct calibration calibrated at Article 9 of this Affiliated Information;

b) Define the parameters and conditions that use the optimal radiation device to use as the reference value for the test, calibration.

8. The medical facility is responsible for ensuring radiation safety for the help, taking care of the sick person who is diagnosed or treated with ionizing radiation by the measures as follows:

a) Guide to basic measures to ensure the safety of radiation, the safe process before leaving them to participate in these tasks;

b) Provide appropriate protection equipment to reduce the dose of radiation;

c) Control to ensure the dose of radiation these objects must be subject to the duration of the diagnosis or treatment of the person who does not exceed 5 mSv.

9. The medical facility must conduct an investigation, apply remedied measures and form a retention profile on cases of incident medical radiation causing or at risk resulting in a dose of radiation on the person who is greater than expected.

What? 21 -Public radiation control.

The medical facility must make the following requirements to ensure the safety of the public:

1. There is a control measure to allow only medical radiation personnel to be needed and those who are appointed to help the sick person are in the clinic, treating the sick person during the radiation period.

2. There is a deterred to prevent people from going into the area of the radiation equipment control room, where there is radioactive material, the patient ' s room for the treatment of radiation drugs or radiation culture.

3. Only allow patients to treat the radiotherapy to be discharged home when the radiation activity level is assessed and in people the disease does not exceed 400 MBq.

4. The areas surrounding the area of control include the working rooms, walkways, corridors or toilets, the area with the other passer is required to apply the protection measures as follows:

a) Control the radiation level to ensure there is no change in the work process;

b) Use radiation warning signs (warning signs, warning lights, warning signals) and restrictions on people entering these areas.

What? 22 The vice-radiation problem.

1. The medical facility uses radioactive sources, the radiation device must establish and approve the plan for the application of the prescribed-level radiation-grade radiation incident at Digital Information. 24 /2012/TT-BKHCN December 4, 2012 of the Minister of Science and Technology (Ministry of Science and Technology), and approx the plan for the application of radiation incidents, the basic and provincial-level nuclear incident and the specific requirements stipulated at the 2, 3, and 4 Articles.

2. The medical facility that uses the X-ray projection device that the medical diagnostic must build a radiation incident application plan with the specific requirements as follows:

a) Regulation and examination of the implementation of the precautions to avoid the following incidents:

-For the man not to be in the room for the device when the machine is coming.

-The operator is misplaced the projection, taken, performing a false scan compared to the doctor's designation, screening the wrong person;

-The damage device causes the radiation not correct with the intended and must be shown again.

b) The regulation of an assessment of the dose assessment and monitoring of the health status on the person of the X-ray disease intervened when the incident occurred significantly overdoses compared to the expected dose level; the investigation assessed the radiation dose and the monitoring of the disease. health condition for the medical radiation staff in radiation situations exceeds the prescribed dose limit;

c) The responsibility of the responsibility for reporting when the incidents stated at Point a and in cases of overdoses stated at the b Point of this paragraph;

d) Regulation and retention of records for incidents of incidents occurred.

3. The medical facility uses radioactive drugs to diagnose, the treatment must build up the plan to respond to radiation incidents with the specific requirements as follows:

a) Regulation of measures to avoid the incidents and process of application in the cases of the following incident:

-Radiation loss;

-Contaminated radioactive contamination;

-For the man not to be in the radiology clinic while working;

-Use the wrong dose, the wrong type of radiation, the wrong person, the dose of the wrong radiation.

-Fire fire holding radioactive drugs, radiation storage, radioactive waste;

-Break, breach of storage, process. What? Liquid radioactive waste.

b) The regulation of an assessment of the risk assessment and monitoring of the health of the person who is given to drinking or injecting a radioactive medication is wrong or wrong compared to the doctor ' s designation, which is likely to cause a radiation dose to the person significantly larger than that of the disease. the expected dose; the evaluation of the dose of radiation screening and monitoring of health conditions for the medical radiation staff in the affected situations exceeds the limiting dose limit; the investigation assessed the level of impact on the public and the environment in the conditions. case of incident;

c) The responsibility of the responsibility for reporting when the incidents stated at Point a and in cases of overdoses stated at the b Point of this paragraph;

d) The regulation of and retention of records for incidents occurred;

The rules of the incident.

4. The medical facility uses the radiotherapy device, the hidden source of radiation for the radiotherapy to build a radiation incident application plan with the specific requirements as follows:

a) Regulation of measures to avoid the events of the incidents and the application process in the event of the following incidents:

-Loss of radiation.

-The radioactive source is not returning to the security position and the incidents involved in other equipment failure;

-The source leaked, damaged contaminated with radioactive contamination;

-Fire, fire on the radiation device, the storage cell.

-He was not part of the radiation cell during the time of radiation therapy.

-Radiation incidents to the sick: projection of the wrong person, the wrong radiation, the wrong treatment plan, the actual dose of radiation is greater than the specified level.

b) Regulations on the investigation of the dose assessment, the distribution of the disease on the body of the disease and monitoring the health of the disease in case of a screening of radiation to the patient; investigation assessment of radiation doses and monitoring of health conditions on the patient. the medical radiation personnel in the mapped situations exceeds the limiting dose limit; the investigation assessed the extent of the impact on the public and the environment in the cases of incidents;

c) The responsibility of the responsibility for reporting when the incidents stated at the point a and in cases of radiation incidents stated at the b Point of this paragraph;

d) The regulation of and retention of records for incidents occurred;

The rules of the incident.

What? 23 . Management of radioactive waste, the hidden source of radioactive radiation.

1. Radiation waste produced from activities that use radioactive material in the medical facility (including wastewater contaminated with radioactive contamination from the lab, radiation doses of radiation; bottles of bottles of bottles, tools working with radioactive drugs; sewage wastewater treatment) The patient has used radioactive drugs; paper, radiation-contaminated wipes; xilanhe, needles of radioactive waste; packaging, bottles of radioactive drugs removed; clothing, radioactive powder-contaminated shoes, and other radioactive contamination of other radioactive contamination. has to be collected, stored, processed and discharged under the regulation of radioactive waste management of the Ministry of Science and Technology.

2. Solid radioactive waste (including paper, a radioactive contamination towel; xiluk, needles of radioactive waste); packaging, bottles of radioactive drugs removed; clothing, radioactive powder-contaminated shoes, and other radioactive contamination objects are removed). the security management under the specified regulation at paragraph 1 This must be managed by regulation at the Number Decision. 43 /2007/QĐ-BYT November 30, 2007, of the Minister of Health for the Department of Health's management of medical waste management.

3. The used radioactive sources (including radioactive sources have expired using the magnetic radiation-based radiotherapy device, the radioactive source no longer used in the radiation therapy and other sources of radiation used for the preparation, the study did not). To be managed, stored on the regulation of closed-source radioactivity management using the Ministry of Science and Technology.

What? 24 -Radiation safety records.

The medical facility is responsible for the establishment, retention, and management of radiation safety records by regulation at Article 17 of the number of data. 19 /2012/TT-BKHCN August 8, 2012, of the Ministry of Science and Technology of the Ministry of Science and Technology for the control and safety of radiation in their professional radiation and public screening.

Chapter III

THE RESPONSIBILITY FOR THE SAFETY OF RADIATION

What? 25 . The responsibility of the medical facility and the head of the medical facility

1. The medical facility that uses radiation equipment, sources of radiation, radiation drugs must comply with the requirements for the safety of radiation prescribed in this and other existing law enforcement documents.

2. The medical facility that uses radiation equipment, radiation sources, radiotherapy is only performed in medical radiation after being licensed by the authorities to conduct radiation work.

3. The head of the medical facility must be most responsible for ensuring radiation safety for medical radiation workers, other employees in the medical facility, the public and the environment surrounding it with specific responsibilities as follows:

a) Hold on and implement the provisions of the law on radiation safety guarantee, the requirements for safety of radiation provided at this Federal Information;

b) The policy statement on the safety of the radiation safety of the facility, affirmitation of the commitment to safety guarantees and facilitation of priority conditions for the deployment of radiation safety guarantees;

c) Appoints the person in charge of the safety; specifies the function, duty, and authority of the person in charge of safety; to provide sufficient time and financial conditions so that the person in charge of safety can fulfill his responsibilities;

d) To facilitate inspection of the inspection team, the inspector execs for a specialized inspection of radiation and nuclear safety; provide sufficient information when required;

e) Other tasks suitable, not related to radiation for pregnant female medical radiation staff when receiving a written notice of radiation staff.

What? 26 The responsibility of the curator is safe.

1. The safety curator must be the direct person to conduct radiation work, which has a career expertise, which is trained to grasp the regulations on the safety of radiation safety in health, the law regulations on radiation safety assurance, radiation security and radiation protection, and the safety of radiation. is the Department of Radiation Safety and Nuclear-Ministry of Science and Technology or the Department of Science and Technology of the Provinces, the Central Committee of the Radiation Certificate Authority.

2. The safety curator is responsible for helping the head of the medical facility to implement the rule of law and regulatory requirements at this Federal Information on the protection of radiation safety, including:

a) The implementation of the implementation of technical measures and administrative controls in order to ensure the safe working conditions for employees and the safety of the public in accordance with the ongoing radiation work of the facility;

b) Perform a request for declaration, licensing and extension of the license in accordance with the rule of law;

c) accountable to the head of the facility and the head of the body responsible for the law when to occur the radiation incident or in violation of the laws of law;

d) Petition with the head of the medical facility for other tasks suitable, not related to radiation for pregnant female medical radiation staff when receiving a written notice.

3. The person in charge of the safety of the radiation job is underway when the detection has been detected or the risk of loss of safety.

What? 27. The responsibility of the medical radiation worker

1. The medical radiation worker must be trained and given a degree authority or certificate of professional training, a career that matches the work of radiation.

2. The medical radiation worker is responsible:

a) Training, training in radiation safety at the request of the safety curator;

b) Only engaged in the conduct of radiation work or to do tasks that are at risk of radiation when trained, the training holds the requirements, the rule of law on radiation safety assurance, radiation protection measures, and only radiation equipment, device used in nuclear medicine if there is a labor safety card;

c) Implemendation of the internal integrity, process of work, only the radiation safety of the unit;

d) Use of personal protection, personal doses, radiation testing equipment, action equipment with radioactive sources in the right direction;

Coordinated, collaborating with the person in charge of the safety of the annual health examination, measurement of individual risk assessment;

e) The report immediately to the person in charge of the safety or head of the medical facility of the abnormal phenomena of radiation safety, when the detection of radiation loss and involvement in the recovery of the radiation incident when required.

3. The female medical radiation staff when pregnant is required to inform the person in charge of the safety, the head of the facility to be deployed to other work is not related to radiation.

What? 28. State agency responsibility has jurisdiction in the health care industry

1. The Department of Emergency Management Services-The Ministry of Health makes its coordination with the relevant units, examining the safety of radiation safety for medical facilities in the country.

2. The provincial department of Health, the Central City of the Central City, is responsible for the administration of the administration, which monitors the implementation of the regulations that guarantee the radiation safety of the medical facilities on the site of the administration. The Department of Defense is responsible for managing, examining, carrying out the implementation of the safety regulations of the military facilities in the entire army.

What? 29. Responsible for radiation safety management, nuclear

1. The Department of Radiation Safety and Nuclear-Ministry of Science and Technology is responsible for managing radiation safety on medical facilities in the country, including:

a) Continue to declare a device containing the source of diagnostic imaging, radiation and radiation, radiation, and radiation.

b) Safe appraisor, licensing of radiation work on activities using a device containing a diagnostic imaging source; operation of radiation equipment; storage, use of radioactive sources, radiation drugs; treatment, storage of closed radioactivity has passed. use; build, scale changes and range of radioactivity base activities; end of radiation base operation and acute radiation personnel certification under jurisdiction;

c) Inspector adheres to the law regulations on the safety of radiation safety in health care and treatment for violations.

2. The Department of Science and Technology of the Provinces, the Central City of Central City is responsible for radiation safety management of the health facilities operating on the management site, including:

a) Continue to report on the X-ray device diagnostic in medical;

b) Safe appraisal, licensing of radiation work using X-ray equipment for medical diagnosis and certificate of radiation personnel to the person in charge of the medical facility by jurisdiction;

c) Inspector adheres to the law regulations on the safety of radiation safety in health to the health facilities operating on the management and disposal sites for violations;

d) Coordinated with the Department of Military Health-Ministry of Defense in safety appraisal, licensing of the radiation and inspection work, examination for the use of the X-optical device for medical diagnosis at the military facilities on the management site.

Chapter IV

EXECUTION CLAUSE

What? 30. Apply host texts to

The case of law-breaking text, technical regulation, or standard is invoked in this applicable, complementary, or alternative, according to the revised, complementary or alternative text.

What? 31 The effect of execution.

1. This joint venture has been in effect since 25 July 2014.

2. Digital Federal Information 2237 /1999/TTLT-BKHCNMT-BYT December 28, 1999, of the Ministry of Science, Technology and the Environment and the Ministry of Health guidelines for the implementation of radiation safety in health all over the force since this date of the federation is valid.

In the course of implementation if there is an entangrium, recommended agencies, organizations, individuals in time to reflect on the Ministry of Science and Technology and the Ministry of Health to review the ./.