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Circular 2237/1999/ttlt-Byt-Bvhtt: Guide The Implementation Of Radiation Safety In Health

Original Language Title: Thông tư liên tịch 2237/1999/TTLT-BKHCNMT-BYT: Hướng dẫn việc thực hiện an toàn bức xạ trong y tế

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CIRCULAR guiding the implementation of radiation safety in health _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ pursuant to article 28 (item 2, 3) and article 29 of the Ordinance on radiation safety and control on June 25, 1996;
Pursuant to article 34 and article 48 of Decree No. 50/1998/ND-CP dated 16 July 1998 from the Government detailed rules implementing the Ordinance on radiation safety and control;
Minister of science, technology and Environment Ministry of health guidelines for radiation safety implementation in health as follows: i. the OBJECT and SCOPE of this circular apply to the medical facility and treatment, research, training of medical staff of State, private and other forms , including the basis of foreign investment (hereinafter referred to as the medical establishment) have used x-ray equipment, radiation therapy equipment (hereinafter referred to as the radiation equipment), sealed radioactive sources, radioactive source aperture to medical examination, treatment, scientific research and training.
II. RESPONSIBLE for RADIATION SAFETY 1. The management of radiation in medical establishments: the basis of radiation in medical units (departments, boards, departments, group) use direct radiation, radioactive sealed source or radiation source aperture to examinations and treatment, scientific research and training.
The management of radiation in medical establishments is the head or charge that radiation facility.
Radiation facility managers must have knowledge about radiation safety, to master and implement strictly the provisions of the law on safety and radiation control.
2. The person in charge of the radiation safety of a radiation facility) the person in charge of safety Manager radiation medical decision. The person in charge of the radiation safety must be radiation safety training according to the program by the Ministry of science, technology and environment and the Ministry of health to coordinate regulations and must have the certificate due to the basis of the Ministry of science, technology and the environment allows the training about radiation safety levels. The person in charge of the radiation safety may be the direct examination or healing with concurrent radiation.
b) radiation safety coordinator is responsible for implementation of the regulation referred to in article 11 of the Ordinance on radiation safety and control.
3. The staff of medical radiation: a) radiation worker is the doctor, doctors, nurses, orderlies, pharmacy, engineering, technicians work directly with radiation equipment or radioactive sealed sources, openings or care of patients treated with radioactive isotopes.
b) radiation worker must perform the stipulated in article 12 of the Ordinance on radiation safety and control. Radiation workers must seek exemptions to a minimum dose to the patient while still obtaining all necessary clinical information.
III. PROVISIONS DECLARED, GRANTING Registration, LICENSING 1. Report: a) The radiation facility that uses radiation device, sealed radioactive sources, the source of radiation, radioactive waste within 15 days of having the device must declare to the Department of science, technology and environment of the central cities, where the medical form (Appendix 1 , 1, 2, 3, 4, 5, 6). At the same time submit a report for the Department of health, the central cities (to the track). The case of the sale or transfer of the equipment, the sale or transfer facility must notify in writing to the Department of science, technology and environment of the central cities, where it has been previously declared. Purchase base or assignee must check in with the Department of science, technology and environment of the central cities, where his base.
b) Department of science, technology and the environment has the responsibility to manage. Within 15 days after receipt of the votes declared, Department of science, technology and the environment must submit the Declaration of the Board of radiation and nuclear safety Department of the Ministry of science, technology and the environment.
2. Please registration license: a) The radiation facility have radiation equipment, equipment for radiotherapy, sealed radioactive sources, places to store radioactive waste must apply for certificates of registration, if within six months is not yet planning to use. If planning to use immediately, no need to apply for granting the registration.
Application for granting of registration include:-application level registration certificate (annex 2);
-A copy of the source device, or a copy of their design the whereabouts of radioactive waste.
b) application for granting registration of radiation appliances, radioactive sealed sources, places to store radioactive waste sent to Ban and nuclear radiation safety Department in the Ministry of science, technology and the environment.
c) application for granting registration of the x-ray equipment (except accelerators) sent to the Department of science, technology and the environment where the radiation facility.
d) Department of science, technology and the environment monthly must send a list of statistics registration certificate has been issued in the last month of the Board of radiation and nuclear safety Department of the Ministry of science, technology and the environment.
3. Please license the work of radiation (hereinafter called permit), and the special radiation: a) When preparing to conduct radiation work, the following objects must please license:-The basis of the use of radiation, radioactive sealed sources of radioactive sources, openings.
-The basis of the export, import, transport equipment for radiation therapy (except transport acceleration), sealed radioactive sources, radioactive source openings.
-The staff do the work a special radiation as the operation, installation and repair of equipment for radiation therapy.
b) application for a license for the facility that uses radiation device, sealed radioactive sources, radioactive source openings include:-an application for license (Appendix 3 form 1).
-Production equipment for radiation, radioactive sealed sources of radioactive sources, openings of the exporter (if available).
-A radiation safety assessment.
-A copy of building design room equipment of radiation or nuclear medicine Lab (or layout of equipment in the room, room size for radiation facility existed before this circular effect),-the list of employees of the radiation, the radiation safety , the level of each person. Private event use radiation equipment must be accompanied by a copy of the license to do the work a special radiation of the person operating the device.
c) application for a license for the export, import, transport equipment for radiation therapy (except transport acceleration), sealed radioactive sources, radioactive source openings include:-an application for license (Appendix 3, model 2, model 3).
-The vote declarations (annex 1).
d) application for license to do the work a special radiation: operation, installation and repair of equipment for radiation therapy of radiation including: staff-level radiation work permit (Appendix 3 model 4).
-Copy of diploma, professional certificates.
-Copy of certificate about radiation safety due to the basis of the Ministry of science, technology and the environment allows the training about radiation safety levels.
-Health certificate by the district health centre, doctor of occupational health centre provincial, city in Central or Institute of medicine and sanitation workers.
DD) application for a license for the use, export, import, transport equipment for radiation therapy (except transport acceleration), sealed radioactive sources, radioactive sources, radiation work particularly sent to the radiation safety Committee and Ministry of nuclear science, technology and the environment.
e) application for a license for the use of the x-ray equipment (except accelerators) sent to the Department of science, technology and the environment where the radiation facility. Department of science, technology and environment, in collaboration with the Department of Health Organization radiation safety assessment before the Department of science, technology and the environment.

g) Department of science, technology and the environment must submit a list of statistics of license granted in the year and a report on the situation of safety and radiation control in the local scope in that year on the Board of radiation and nuclear safety Department of the Ministry of science, technology and environment prior on December 20.
4. The declarations, the registration and license please please license can do at the same time.
5. At the latest 60 days before the expiry of the permit before the radiation facility have to do renewals procedure where have the license.
Application for renewal, including:-an application for renewal (Appendix 4).
-A radiation safety assessment.
6. The basis of radiation when wanting to upgrade, expand, the purpose of the regulations operating out of license, or when wanting to upgrade radiation devices in addition to the content of the registration certificate must implement the provisions of article 30 of Decree No. 50/1998/ND-CP dated 16 July 1998 of the Government.
7. Revocation of a licence is made under the provisions of article 32 of Decree No. 50/1998/ND-CP dated 16 July 1998 of the Government.
8. The Ministry of science, technology and environment, Department of science, technology and environment made the granting of registration, licensed under the provisions of article 23, paragraph 2 b, c, and article 24, paragraph 2 item b, c of the Ordinance on radiation safety and control.
9. The base level radiation, registration or license renewals, amendments permit must submit the evaluation fee and fees prescribed by the Ministry of Finance (article 27 of the Ordinance on radiation safety and control).
IV. TECHNICAL REQUIREMENTS Of RADIATION DEVICES 1. General requirements for the x-ray equipment and radiation equipment contains radioactive sealed sources used for examination and healing: a) To match the international standards or Vietnam.
b) must have the documentation that came with the device, such as technical characteristics, operation, and maintenance instructions, including guidelines for safety and must be translated into Vietnamese.
c) should have automatic control structure beam.
d) Must limit the irradiation in the area was discovered and the healing of the sick.
2. Requirements for x-ray equipment or equipment for radiotherapy sealed sources used for examinations: a) x-ray equipment and accessories attached to ensure low irradiation level, logical, consistent with obtaining the required information.
b) the latest in x-ray equipment such as high-voltage (KV), an upscale line (mA), time (s), mAs, points of convergence, the convergence distance, school size, filter plate must be specified and accurate.
c) In capture mode, the machine must be equipped with the time to terminate the irradiation after reaching the level stated.
In slide show mode, the machine must be equipped with the time restrictions.
3. The requirements for radiation equipment to healing: a) radiation equipment must be equipped with the means to control the operating parameters such as: the type of radiation, the energy of the beam adjustment (such as filter plates), projection distance projection field size, beam direction and duration or dosage given.
b) irradiated equipment using radioactive sources must automatically return to a safe location when there is trouble, sources still maintain shield of protection until the beam control mechanism be restarted from control cabinets.
c) Alternatively, remote radiation therapy equipment (teletherapy) also need: – there are two systems of self returns the location of the safe when there is trouble in order to terminate the irradiation.
-Have the safety interlock is or means to terminate the irradiation when the machine operates in conditions other than specified conditions available from control cabinets.
d) interlock must ensure safety when servicing the machine, if the interlock switches temporarily affected still operate are under the direct control of staff maintenance thanks to the tool, or the appropriate key code.
DD) radioisotope sources used for remote radiation therapy or proceeding was proper according to the structural definition of the sealed sources.
V. ROOM LAYOUT PLACED Rooms EMISSION EQUIPMENT equipment emission: a) needed far from crowded areas, the area of obstetrics and Pediatrics, other departments of the hospital has no directly related to radiation and are far from public access.
b) x-ray Rooms are sized as required by the standards of Vietnam, not window 2 m lower than the outer decks.
c) remote radiation therapy Room (teletherapy) has an area of not less than 30 m 2, width not less than 4 m, height not lower than 3 m, the system must be light and well ventilated.
d) When calculating the thickness design, wall, floor, ceiling, doors of the room put the radiation equipment must note the device's parameters (voltage, amperage, or operation of radiation sources), the use, occupation coefficient of each area outside room settings to ensure the holding of the annual limit dose for people outside the room is 1mSv. dd) equipment be screened to stars for the limited doses annually for employees operate the machine not in excess of 20mSv.
1. radiation equipment layouts: a) each room just put a radiation device. The case has put the two x-ray machines, the two machines are not active simultaneously in the same time. Radiation equipment is put to use, not Ray control cabinets, doors, Windows or areas.
b) radiation device control Cabinet must put aside, room equipment, must have the means to observe the patient, has the news media between the operator and patient. Private x-ray equipment case working on the smaller pressure 150 KV, control cabinets can be placed in the room settings but are there screens lead.
2. in the room equipment radiation is radiation measuring devices mounted automatically to alarm about any unusual condition when using the equipment.
3. The path to the device remote radiation therapy are designed to go "really get the Cossacks" (zigzag).
4. the radiation room doors must have remote interlock to: a) Just start radiation device when the door is closed completely.
b) automatically terminate the irradiation when the door was opened.
5. Warning signals: a) Placed at the top of the door to the room of a radiation device, the red light illuminates when radiation equipment began operating.
b) placed on the doors of rooms the radiation device in a sea of radiation warning (Appendix 1).
VI. GENERAL REQUIREMENTS For RADIATION SAFETY For NUCLEAR Medicine 1. Nuclear medicine need to layout the difference from other departments to people on other departments do not have to go through this science.
At the entrance to the faculty to have radiation warning sea (Appendix 5) 2. The layout of the rooms in the Faculty according to the principle: the descending radioactive dose inside out or from bottom to top if faculty have many floors (the repository of radioactive substance, radioactive substance in blending in together). The rooms have a radioactive source openings are arranged adjacent to each other to avoid widespread radioactive contamination.
3. Requirements for radioactive sources have openings: a) must be good ventilation.
b) the thickness of the walls, floor, ceiling, doors of the room must be calculated as for the radiation equipment rooms to shield the radiation doses are kept to ensure that the annual limit for people outside the room is 1mSv. Rugged, no walls are coated with waterproof, easy to purge.
c) the floor of the room need waterproof ring coating, has drained out trench for radioactive waste water.
d) surface of the desk with the radioactive source are made from flat material, do not absorb radiation, no stretch marks, crevasses, easy to purge.
DD) Washbasin faucet has been controlled with the foot or hand or automatic khuỷ.
e) to Cabinet jobs with specific types of radioactive material has arisen.
g) Must use the clamp (pint) or cylinder was shielding to reduce the dose in the hand.

4. Must be equipped with a minimum of tools measure:-Air standard doses of radioactive pharmaceuticals.
-Power meter penetrating, with the appropriate dose.
-Surface contamination detector, sensitive enough to emit radiation.
5. The radioactive source openings should be stored in a separate repository contains tags. Where the use of radioactive sources for preservation as open wall cavities, cabinets should have many compartments to when arranged or take the radioactive material in the prevent employees from being screened by the other pane. Each compartment has doors open, labeled name and function of each radioactive isotopes in the inside. The radioactive isotopes have to be contained in the packaging (glass bottles, plastic bottles, metal box). When exporting, importing radioactive isotopes to trace logging.
6. Must have room to save patients who have used the drug. The room must be adequately shielded to ensure external dose capping the room does not exceed the annual dose limit for the public (1mSv/year). Each room just to save a patient, there are many cases of patients in a room, they must have mobile lead screens to shield stars for patients not affected radiation from the other patients.
Mobile lead screens must have used the shield to staff in contact with the patient.
The patient was discharged only when the activity of radioactive material in the body falls below the prescribed level (Appendix 6).
7. When the radioactive contamination must proceed to purge.
The areas of radioactive contamination must be purged from the radiation in order to reduce to a minimum the spreading contamination.
The person in charge of the radiation safety must be present when conducting the purge.
VII. management of RADIOACTIVE WASTE 1. The radioactive waste in the form of gas, liquid and solid waste into the environment only after having checked the reach the limits allowed under the regulations of the Ministry of science, technology and the environment.
2. sealed sources used in radiation therapy, effective after the radioactive waste must be stored in a separate repository are radiation shielding and protection against theft.
3. The basis of radioactive waste has a half-life short (under 30 days), the activity of private activity or greater than the level of immunity must be kept during the period needed to decay to the extent that they allow newly discharged into the environment. Namely: a) for liquid waste: liquid waste (including secretion of patients taking radioactive pharmaceutical) is said to flow into the underground tank circulation have tightness required to the fluid seep out, enough radiation shielding as required, precipitation covered, there are enough capacity to allow retention of liquid waste in time of need (10 cycles half of the longest living isotope isotopes are discharged). A hot liquid radioactive waste received daily, while the other used tank retention of liquid radioactive waste pending release or liquid waste are concentrated and diluted with waste water often in hot mix according to the regulations of the Ministry of science, technology and the environment.
b) for solid waste: solid materials radioactive contamination: ampules, glass breakage, ... collectors in the plastic packaging, the packaging is placed in the Recycle Bin are metal, collapsible by foot. Daily packaging is put into one of the two hot difference as for liquid waste. The tank is built in a separate place, shielded and protected to wait for radioactive decay to smaller levels of regulation, then emissions as regular trash.
4. The management identify small animals containing radioactive substances in the laboratory under separate regulations.
VIII. QUALITY CONTROL, EQUIPMENT CALIBRATION, measure RADIATION DOSE of clinical, QUALITY ASSURANCE in medical IRRADIATION 1. The source of the radiation, the radiation equipment used in health must be inspected periodically and calibration once a year. After installation, the repair must be the new calibration is put into use. The basis of the quality control and calibration of radiation equipment by the Ministry of science, technology and the environment (this base must be qualified and have the expertise and equipment radiation safety...).
2. The characteristic values of the parameters of the patient's clinical doses must be defined and stored in the profile.
4. The radiation facility, in addition to the implementation of the regulations on quality assurance, radiation safety management must establish a quality assurance program for medical irradiation, with the participation of qualified experts in the relevant fields such as radiation physics , radioactive pharmaceuticals and must comply with the guidelines by the Ministry of health and the World Health Organization (WHO) regulations.
4. The programme ensuring medical irradiation must include: a) annual periodic measurements of physical parameters of the radiation from the device when began and during use.
b) examines the physical and clinical factors in diagnosis and treatment of patients.
c) keep records of the process and the results are relevant.
d) check the calibration, the operating conditions and the measurement equipment and radiation dose.
DD) reassess the results of independent quality control and of quality assurance program for the radiation therapy process.
IX. The REQUEST When Medical IRRADIATION 1. General provisions.
a) all of the medical irradiation should be considered based on the comparison with the other methods on the benefits and damages they cause and specified by the physician. When there are two treatments together brought to an equally effective, does not use radiation methods.
b) only one patient and if necessary add a few people helping patients in the irradiation room.
2. Passport, taken to the examination and healing.
a) doctor or technician to conduct screenings, taken to:-ensure the device used is appropriate.
-To select the working copy for the entire work put together just make a minimum irradiation doses for patients but the image quality remains consistent with the requirements of the diagnosis, the need to pay special attention to this when it premiered, shooting for kids.
-Reference information of the visit in advance to avoid capture, replay if needed.
b) projection equipment, portable or mobile capture is used only when the patient cannot be moved to fixed base due to the condition of the patient or other actual conditions and only after safety measures for the use of the equipment.
c) Avoid abdominal and pelvic irradiation of pregnancy or suspected pregnancy unless there is clinical reasons and are required to do, in that case you need to use the measures necessary to cause only minimum dose to the fetus.
d) agencies sensitive to the radiation of the patient's body (such as the gonads, glass of eye, breast, thyroid) should be screened.
3. Examination and healing in nuclear medicine.
a) doctor visit, healing with radioactive material should:-ensure the dose for patients is minimized but a proposed clinical purposes.
-Reference information of the visit in advance to avoid unnecessary additional testing.
-Refer to the activity level of instruction for medical irradiation of domestic and foreign agencies such as IAEA, the WHO ... b) avoid the use of radioactive material to examination for pregnancy or suspected pregnancy unless clinically indicated.
c) for women who are breastfeeding, need to pause work nursing until radioactive drugs don't affect the child.
d) only used a radioactive substance to clinics for young indicated the required clinical activity and is indicated to reduce as required.
DD) the patient must be informed of the risks that can occur when using the radioactive substance.
4. Helping patients were irradiated.

a) nobody is allowed to stay in the clinic, healing during irradiation, except the necessary radiation workers and those who are allowed to help patients when medical examination and treatment.
b) pregnant women, people under 18 are not allowed to help patients when being irradiated.
c) Who help patients while being irradiated must carry appropriate protection tools (lead rubber apron, rubber gloves, protective cloak of lead, lead screens). Even when it was using protection, not a part of their body in the way of the useful beam.
d) caregivers, help patients with medication or radioactive irradiation must be controlled doses.
X. OPERATING SAFETY RADIATION DEVICES 1. The radiation facility is constructed and enacted rules to use the room air, the procedure for each device, treatment for the condition to ensure safety for staff and patients to radiation.
2. radiation workers must:-check the safe source before operation and after finishing the work.
-Close the door during operation of the machine.
-Compliance with the process of operating the machine.
-Note the unusual signal of the device type to timely detect the problem, prevent accidents.
-Do not remove the parts are damaged in depth protection system to operate directly by hand.
-Operational data store.
-Immediate notification for the Radiation Facility Manager or person in charge of the radiation safety if detected radioactive sources, ability to take all-out radiation incidents. Within the scope of his responsibility to fix the problem of radiation.
-Use the means of ensuring the appropriate radiation safety with work.
3. Equipped with means of ensuring radiation safety.
-Each basis of radiation emission control equipment should match the device's radiation facility.
-Those who work directly with the radiation source must be equipped with the necessary protection such as screens, cynical gum lead pencils, rubber gloves, goggles, lab coat, boots, design appropriate individual dose, the te lead to contain radioactive isotopes when shipping.
-Medical facility managers must ensure adequate provision means.
XI. The INVESTIGATION Of The ACCIDENT By Medical IRRADIATION For PATIENTS 1. Radiation facility managers is to investigate immediately the following incident: a) radiation in the wrong patient, wrong model, wrong drug, wrong dose of radiation have different values than the value specified by the doctor.
b) Radiation Dose significantly greater levels of diagnosis or the dose due to repeated radiation diagnosis significantly exceeds the level of instruction.
c) any damage of the equipment, any accidents, mistakes and any other unusual risks likely to cause patients doses significantly beyond the projection indicated.
2. After investigating the incident mentioned above, the radiation facility managers must: a) To calculate or re-evaluate the doses received by patients.
b) proposed measures to remedy, cure patients, prevent the problem recurring.
c) immediately report in writing to the Agency on the after investigations and conclusions about the cause of the problem. The case caused serious consequences are reported to the radiation and nuclear safety Department of the Ministry of science, technology and the environment.
d) information for the patient about the issue.
XII. hosting 1. The radiation facility to preserve and archive the records of patients in time for at least five years: a) In radiation diagnosis: the necessary information (voltage, current, time) to evaluate the dose after this, including the number of irradiated, date of capture, projection.
b) In nuclear medicine: the radioactive drug used and their activity, the date of use.
c) In radiation therapy: description of the projection, the dose at the center of the projection, the dose in the other relevant organizations, the number of passport, date of passport.
2. The radiation facility to store the results of the calibration times, periodic checks, the relevant physical parameters selected in the times during radiation therapy for at least five years.
3. time health records and records of employee screening radiation doses as specified in clause 5 article 9 of Decree No. 50/1998/ND-CP dated 16 July 1998 of the Government.
XIII. IMPLEMENTATION 1. Department of science, technology and environment and the Health Department of the province, central cities perform management functions of State supervision, examine the implementation of radiation safety in the radiation facility in the local scope.
2. The basis of radiation has entered or is being stored, the use of radiation appliances, radioactive sealed sources, the source of radiation, radioactive waste prior to this circular, within 90 days from when the circular effect, the procedure must declare, then must do the procedures applying to license as specified in section III of this circular.
In the meantime be licensed, the basis of this radiation still used the radiation equipment and radioactive substances.
Within three years from when a circular effect, the basis of radiation would not meet the requirements specified in section II, IV, V, VI, VII, VIII, X and XII, they must follow the provisions of this circular.
3. The Health Ministry indicated the basis of examination and treatment, health monitoring for those irradiated overdose and getting sick because of radiation damage.
4. after the base private radiation, radiation facility has invested gnoài are fully licensed radiation safety as defined in section III of this Information, the Ministry of health, the Department of health to review the certification standards and conditions of practice as required by the law on the private medical practice , the law on examination of foreign investment.
XIV. EFFECTIVE ENFORCEMENT of this circular effect after 15 days from the date of signing.
In the process if there are obstacles to timely reflect the proposal with The Union to resolve./.