JOINT CIRCULAR

GUIDING THE IMPLEMENTATION OF MEDICAL RADIATION SAFETY

Pursuant to Article 28 (Clauses 2 and 3) and Article 29 of the Ordinance on Radiation Safety and Control of June 25, 1996;
Pursuant to Articles 34 and 48 of Decree No.50/1998/ND-CP of July 16, 1998 of the Government detailing the implementation of the Ordinance on Radiation Safety and Control;
The Ministry of Science, Technology and Environment and the Ministry of Health hereby guide the implementation of medical radiation safety as follows:

I. OBJECTS AND SCOPE OF APPLICATION

This Circular shall apply to medical examination and treatment establishments, medical and pharmaceutical research institutions and medical and/or pharmaceutical personnel training establishments, which are run by the State, private individuals or in other forms, including foreign-invested establishments (hereafter referred collectively to as the medical establishments), which use X-ray equipment, radiotherapy equipment (here after referred collectively to as radiation equipment), closed and/or open radioactive sources for medical examination, treatment, scientific research and/or training.

II. THE RESPONSIBILITY TO ENSURE RADIATION SAFETY

1. Persons managing radiation sections in the medical establishments:

Radiation sections in medical establishments are units (faculties, bureaus, boards, departments, groups) directly using radiation equipment, closed or open radioactive sources for medical examination, treatment, scientific research and/or training.

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The radiation section managers must have knowledge about radiation safety, firmly grasp and strictly observe the law provisions on radiation safety and control.

2. Persons in charge of radiation safety of the radiation sections:

a) Persons in charge of radiation safety shall be decided by the managers of medical establishments. They must be trained in radiation safety under the programs jointly set by the Ministry of Science, Technology and Environment and the Ministry of Health and be granted the certificates by establishments permitted by the Ministry of Science, Technology and Environment to conduct radiation safety training. The persons in charge of radiation safety may be those who directly give radiotherapy.

b) Persons in charge of radiation safety have the responsibility to implement the regulations set in Article 11 of the Ordinance on Radiation Safety and Control.

3. Radiation personnel of the medical establishments:

a) The radiation personnel include doctors, assistant doctors, nurses, orderlies, pharmacists, engineers and technicians directly working with radiation equipment or closed or open radioactive sources, or tending patients treated with radioactive isotopes.

b) The radiation personnel must abide by the regulations in Article 12 of the Ordinance on Radiation Safety and Control. They must seek ways and means to minimize doses applied to patients while still being able to gather all necessary clinical information.

III. REGULATIONS ON DECLARATION, GRANTING OF REGISTRATION PAPERS, GRANTING OF PERMITS

1. Declaration:

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b) The provincial/municipal Science, Technology and Environment Services shall have to synthesize cases for management. Within 15 days after receiving the declarations, the Science, Technology and Environment Services shall have to forward such declarations to the Radiation and Nuclear Safety Board of the Ministry of Science, Technology and Environment.

2. Applying for registration papers:

a) Radiation sections having radiation equipment, radiotherapy equipment, closed or open radioactive sources and/or radioactive waste depots shall have to apply for registration papers if they have no plans for use within six months. If they have plans for immediate use, they need not to apply for registration papers.

A dossier of application for registration paper shall include:

- The written application for registration paper.

- The copy of the record on the equipment, the sources or the copy of the design of the radioactive waste depot.

b) The dossiers of application for the registration of radiotherapy equipment, closed or open radioactive sources or radioactive waste depots shall be sent to the Radiation and Nuclear Safety Board of the Ministry of Science, Technology and Environment.

c) The dossiers of application for the registration of X-ray equipment (excluding accelerators) shall be sent to the provincial/municipal Science, Technology and Environment Services of the localities where the radiation sections are located.

d) Monthly, the provincial/municipal Science, Technology and Environment Services shall have to send the lists of registration papers issued in the month to the Radiation and Nuclear Safety Board of the Ministry of Science, Technology and Environment.

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a) When preparing to perform radiation work, the following subjects shall have to apply for permits:

- Establishments using radiation equipment, closed radioactive sources, open radioactive sources.

- Establishments exporting, importing and/or transporting radiotherapy equipment (except for the transportation of accelerators), close radioactive sources, open radioactive sources.

- Personnel performing special radiation work such as operation, installation or repair of radiotherapy equipment.

b) The dossier of application for a permit submitted by an establishment using radiation equipment, closed radioactive sources, open radioactive sources shall include:

- The written application for the permit.

- The licenses for manufacture of radiation equipment, closed radioactive sources and/or open radioactive sources of the exporting countries (if any).

- The written assessment of radiation safety.

- The copy of the construction designs of rooms for installation of radiation equipment or rooms for nuclear medicine practice (or schemes of arrangement of equipment in the rooms, the room sizes, with regard to radiation sections which have existed before this Circular takes effect).

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c) The dossier of application for a permit for export, import or transportation of radiotherapy equipment (excluding the transportation of accelerators), closed radioactive sources and/or open radioactive sources shall include:

- The written application.

- The written declaration.

d) The dossier of application for a permit for performing special radiation work: operation, installation or repair of radiotherapy equipment submitted by radiation personnel shall include:

- The written application for a permit to perform the special radiation work.

- Copies of professional diplomas and certificates.

- The copy of radiation safety certificate granted by an establishment permitted by the Ministry of Science, Technology and Environment to provide the radiation safety training.

- The health certificate granted by a health center of the district or higher level, the occupational disease examination bureau of the provincial/municipal prophylactic medicine center or the labor medicine and environmental hygiene institute.

e) The dossiers of application for permits for the use, export, import or transportation of radiotherapy equipment (excluding the transportation of accelerators), closed radioactive sources, open radioactive sources or the performance of special radiation work shall be addressed to the Radiation and Nuclear Safety Board of the Ministry of Science, Technology and Environment.

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g) The provincial/municipal Science, Technology and Environment Services shall have to forward the lists of permits granted in the year and report the radiation safety and control situation in the year within their respective localities to the Radiation and Nuclear Safety Board of the Ministry of Science, Technology and Environment before December 20 every year.

4. The declaration, the application for registration papers and the application for permits may be carried out simultaneously.

5. At most 60 days before the expiry of their permits, radiation sections shall have to fill in the procedures for the extension thereof at the offices where the permits were granted.

The dossier of application for the extension shall include:

- The written application for the extension.

- The written assessment of radiation safety.

6. When wishing to upgrade or expand the scope and/or purpose of activities beyond the provisions of their permits or when wishing to upgrade their radiation equipment beyond the contents of the registration papers, the radiation sections shall have to comply with the provisions in Article 30 of Decree No.50/1998/ND-CP of July 16,1998 of the Government.

7. The withdrawal of permits shall comply with the provisions in Article 32 of Decree No.50/1998/ND-CP of July 16,1998 of the Government.

8. The Ministry of Science, Technology and Environment and the provincial/ municipal Science, Technology and Environment Services shall grant the registration papers and the permits according to the provisions in Article 23, Clause 2, Items b and c, and Article 24, Clause 2, Items b and c of the Ordinance on Radiation Safety and Control.

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IV. TECHNICAL REQUIREMENTS ON RADIATION EQUIPMENT

1. The general requirements on X-ray equipment and radiotherapy equipment containing closed radioactive sources used for medical examination and treatment must:

a) Be compatible with international or Vietnamese standards.

b) Be accompanied with documents on their technical properties, instructions on operation and maintenance as well as on safety, which must be translated into Vietnamese.

c) Be structured to automatically control ray streams.

d) Be able to restrict radiation within examination and treatment areas on patients.

2. Requirements on X-ray equipment or radiotherapy equipment using closed radioactive sources for examination:

a) The X-ray equipment and accessories must ensure low and reasonable radiation level suitable to the requirement to get information.

b) Parameters put on X-ray equipment such as high voltage (kV), electric current (mA), radiating duration (s), mAs, focal point, focal distance, size of radiating field, filter sheet, must be clearly and accurately indicated.

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In radioscopy, the machine must be equipped with a time control device.

3. Requirements on radiation equipment used for medical treatment:

a) The radiation equipment must be furnished with devices to control operation parameters such as type of radiation, energy, adjuster of ray streams (like filter sheet), radiotherapy distance, size of radiating field, ray stream direction finder and radiotherapy duration or prescribed dose.

b) Radiation equipment using radioactive sources must automatically return to the safety position in the event of incident and the source shall be shielded for protection till the ray stream control structure is re-started from the control cabinet.

c) Besides, the radio teletherapy equipment must also:

- Have two systems for automatic return to safety position in order to terminate the radiation in the event of incidents.

- Have automatic safety lock or device to terminate the radiation when the machine operates under conditions other than those pre-determined from the control cabinet.

d) The automatic safety lock must be designed in a way that if it temporarily stop working when the machine is being under maintenance, the machine still operates through the direct control of the maintenance personnel with appropriate tools, code or key.

e) The radioactive isotope sources for teletherapy or direct therapy is structured in strict accordance with the definition of the closed source.

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Rooms for installation of radiation equipment:

a) Must be placed far away from crowded places, obstetric and pediatric departments as well as other departments of hospitals, which are not directly related to radiation, and far way from public passages.

b) The X-ray room shall have the size according to Vietnamese standard, with air ventilation windows being not lower than 2m from the outer floor.

c) The radio-teletherapy room which measures not smaller than 30 m2, with the width being not shorter than 4m and the height being not lower than 3m, must have a good lighting and air ventilation systems.

d) When calculating and designing the walls with proper thickness, the floor, ceiling and door of the room where radiation equipment is installed, attention shall be paid to the parameters of the equipment (electric voltage, electric current or radiant intensity of the source), the equipment usage coefficient, the special occupation coefficient of each area outside the radiation equipment room in order to ensure that the annual limited dose for population outside the room is kept at 1mSv.

e) The equipment is shielded off in order to ensure that the annual limited dose for personnel operating the machine shall not exceed 20mSv.

1. Radiation equipment arrangement:

a) Each room is furnished with one radiation equipment. Where a room is furnished with two X-ray machines, such two machines must not operate simultaneously at a time. The radiation equipment must be installed in a way that when it operates, the radiation rays are not directed at the control cabinet, doors, windows or crowded places.

b) The control cabinet must be placed outside, close to the radiation equipment room, and must be equipped with device to monitor patients and device for communication between the operators and patients. Particularly for X-ray equipment operating at a voltage lower than 150kV, the control cabinet may be placed inside the equipment room but must be shielded off with lead screen.

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3. The passage to the place where the radio-teletherapy equipment is installed must be designed in zigzag.

4. The door of the radio-teletherapy room must be equipped with combined automatic lock in order to ensure that:

a) The radiotherapy equipment can start only when the door is completely closed.

b) The radiation shall automatically terminate when the door is suddenly opened.

5. Warning signals:

a) Placed above the door of the radiation equipment room is a red lamp which illuminates when the radiation equipment starts operating.

b) Placed above the door of the radiation equipment room is a radiation warning signboard (Appendix 5).

VI. GENERAL REQUIREMENTS TO ENSURE RADIATION SAFETY FOR NUCLEAR MEDICINE DEPARTMENTS

1. The nuclear medicine department must be separated from other departments so that people entering other departments must not pass through the former.

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2. The department’s rooms shall be arranged according to the principle of lower and lower radiation dose from inside to outside or from lower to upper storey if the department occupies many storeys (radioactive pharmaceutical substance storehouse and the radioactive pharmaceutical preparations room are arranged innermost). Rooms with open radioactive sources are arranged successively in order to avoid large-scale radioactive contamination.

3. Requirements on rooms with open radioactive sources:

a) Being well ventilated.

b) Their wall thickness, floor, ceiling, door must be calculated and made like those of radiation equipment rooms to shield off radiation with a view to keeping the annual limited dose for population outside the room at 1mSv. The wall shall not be rough and must be coated with an water-proof layer easy for radiation erasing.

c) The room’s floor should be coated with an water-proof layer, with water drainage conduit to radioactive waste water ditch.

d) The surface of radioactive source desk must be made of smooth materials non-absorbing of radioactive substance, non-cracked and easy for radiation erasing.

e) The cleaning basin shall be furnished with tap(s) which can be operated with foot or elbow or automatically.

f) Being furnished with dust-cleaning cabinet of the type used exclusively for work involving radioactive substances emitting vital force.

g) Shielded pincers or syringes must be used to reduce doses on hand.

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- The radioactive pharmaceuticals dosemeter.

- The dose-ration meter with appropriate precision.

- The surface contamination detector, with enough sensitivity to emitting radiation.

5. The open radioactive sources must be preserved in separate storehouses with locks. Places for preserving open radioactive sources such as niches, wardrobes should be designed with may drawers so that when putting in or taking out of such drawers radioactive substances, personnel shall not be subject to radiation from other drawers. Each drawer is made with a separate door with label inscribing clearly the name and intensity of each radioactive isotope therein. The radioactive isotopes must be kept in solid packages (glass containers, plastic containers, metal containers). The taking out and putting in of radioactive isotopes must be recorded in diary for monitoring.

6. There must be rooms for confinement of patients who have used radioactive drugs. Such rooms must be shielded off to keep the outside dose within the annual dose limit for population (1mSv/year). Each room shall confine one patient. In cases where many patients are confined in a room, there must be mobile lead screens to shield off radiation from one patient to another.

Also there must be mobile lead screens to shield personnel when contacting patients.

Patients shall be discharged from hospitals only when the intensity of radioactive substance in their bodies reduces to below the prescribed limits (Appendix 6).

7. Radioactive contamination, when it occurs, must be done away with.

Areas contaminated with radioactive dusts must be cleansed from the outside inward in order to minimize the spread of contamination.

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VII. MANAGEMENT OF RADIOACTIVE WASTES

1. Radioactive wastes in gaseous, liquid or solid form shall be discharged into the environment only after they are inspected and reach the permitted limits prescribed by the Ministry of Science, Technology and Environment.

2. The closed sources used in radiotherapy, after becoming radioactive wastes at the end of its utility, must be preserved at separate storehouses shielded to keep off radiation and protect against stealing.

3. Radioactive wastes with short-term deactivation cycle (under 30 days) and with the general intensity or separate intensity being higher than the immunity level must be kept at establishments within a period of time necessary for their self-deactivation to the permitted levels before they are discharged into the environment. More concretely:

a) For liquid wastes: The liquid waste (including excreta of patients having used radioactive pharmaceuticals shall be led into either of 2 underground tanks which are unconnected to each other, tight-close enough to prevent liquids from penetrating outside and to shield off radiation, and large enough to hold the liquid wastes within necessary period of time (10 semi-deactivation cycles of the longest alive isotope among the discharged isotopes). One tank takes in liquid radioactive wastes discharged daily while the other tank is used for storing liquid radioactive wastes awaiting to be discharged into the environment or the liquid wastes are gathered then diluted with ordinary waste water in the mixing tank according to the regulations of the Ministry of Science, Technology and Environment.

b) For solid wastes: Solid materials radioactively contaminated: injection ampoules, broken glass… shall be gathered into plastic bags placed into metal barrels which is closed and opened by foot. Daily, these bags are brought into either of the two separate tanks like for liquid wastes. These tanks are built in separate areas, shielded off and protected till the radioactive substances disintegrate to below the prescribed level, then the bags are discharged into environment like ordinary garbage.

4. The management of small animal bodies containing radioactive elements in laboratories shall comply with the separate regulations.

VIII. QUALITY CONTROL AND RECTIFICATION OF RADIATION EQUIPMENT, MEASUREMENT OF CLINICAL DOSES, ASSURANCE OF MEDICAL RADIATION QUALITY

1. Radioactive sources and radiation equipment used in the medical service must be quality-controlled and rectified once a year. After they are installed or repaired, they must be rectified before being put into use. The establishments conducting the quality control and rectification of radiation equipment shall be appointed by the Ministry of Science, Technology and Environment, (which must satisfy the conditions on personnel qualified for radiation safety operation and equipment...).

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3. The radiation sections, apart from observing the regulations on ensuring the quality of radiation safety management, shall have to work out a program on ensuring the specific quality for medical radiation, which involves specialists with appropriate qualifications in relevant fields such as radioactive physiotherapy, radioactive pharmaceuticals, and shall have to comply with the principles set by the Ministry of Health and World Health Organization (WHO).

4. The medical radiation ensuring programs must include:

a) The annual measurement of physio-parameters of radiation equipment from the beginning and during their subsequent use.

b) Examination of physio-clinical elements in diagnosis and treatment of patients.

c) Archiving of records on relevant processes and results.

d) Examination of rectification, conditions for operation and dose-measuring and radioactive inspection devices.

e) Reevaluation of results of independent and regular inspection of quality of the program on ensuring the quality of radiotherapy processes.

IX. REQUIREMENTS WHEN CONDUCTING MEDICAL RADIATION

1. General provisions.

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b) Only one patient and, if necessary, several persons assisting him/her, are allowed to stay in the radiation room.

2. Radioscopy and photography for medical examination and treatment

a) Doctors or technicians conducting radioscopy and photography shall have to:

- Ensure that the equipment are suitable.

- Select working parameters so that the entire combined work only creates a minimum radiation dose for the patient but the image quality still meets the requirement of diagnosis; special attention should be paid to this when radioscopy and/or photography are performed on children.

- Refer to information from previous examinations in order to avoid repeated radioscopy or photography if not necessary.

b) Portable or mobile radioscopy and photography equipment shall be used only when patients can not be transferred to fixed establishments due to their conditions or other practical conditions and only after safety measures are taken for the use of equipment.

c) To avoid radiation on the belly area and basin area of women who are pregnant or suspected to be pregnant, except where it must be done so due to clinical reasons; for such case, necessary measures should be applied in order to create the minimum dose for the fetus.

d) Patients’ organs which are sensitive to radiation (such as gonad, crystalline lens, nipple, thyroid gland) must be properly shielded off.

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a) Doctors prescribing the medical examination and/or treatment with radioactive substances shall have to:

- Ensure that the dose for the patient is minimum but strong enough to achieve the diagnostic and therapeutic objectives.

- Refer to information from the previous examinations so as to avoid unnecessary additional examination.

- Refer to the radioactive intensity prescribed for medical radiation by domestic and foreign agencies such as IAEA, WHO…

b) To avoid using radioactive substances to give medical examination to women who are pregnant or suspected of being pregnant, except where it must be done so due to clinical prescription.

c) For nursing women, the breast-feeding of their children should be temporarily ceased until the radioactive drugs no longer affect the children.

d) Radioactive pharmaceuticals shall be used for examination of babies only when it must be so due to the clinical prescription and the prescribed radioactive intensity must be reduced according to stipulations.

e) Patients must be notified of possible risks which may entail when radioactive substances are used.

4. Assistance to patients, subjected to radiation.

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b) Pregnant women and persons aged under 18 are not allowed to assist patients when the latter are given radiation.

c) Persons who assist the patients being exposed to radiation must put on appropriate protection devices (rubber-lead napkins, rubber-lead gloves, protection overalls, lead screens). Even when they are equipped with protection devices, not any part of their bodies shall be on the way of the streams of useful rays.

d) Persons tending or assisting patients who are subject to radiation or use radioactive drugs must be dose-controlled.

X. SAFETY IN TRANSPORTATION OF RADIATION EQUIPMENT

1. Radiation sections must elaborate and promulgate the rules on the use of machinery rooms, processes for operation of each equipment, therapy diagram for each kind of illness in order to ensure safety for radiation personnel and patients.

2. Radiation personnel shall have to:

- Check the source safety before operating the equipment and after the completion of work.

- Close the doors throughout the process of operating the machines.

- Abide by the processes of operating the machines.

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- Not to disassemble out-of-order parts in the in-depth protection system for manual operation.

- Archive data on operation.

- Immediately notify the manager of the radiation section or the person in charge of radiation safety of the loss of radiation source, if detected, the possible occurrence of radiation incidents. Within the scope of their responsibility, to participate in overcoming the radiation incidents.

- Use radiation safety means suitable to work.

3. Equipment of radiation safety means.

- Each radiation section should be equipped with radiation control devices suitable to its radiation equipment.

- Persons working directly on radiation sources must be equipped with necessary protection means such as lead screens, rubber-lead napkins, rubber-lead gloves, protection glasses, laboratory overalls, shoes, appropriate personal dosemeters, lead containers to store radioactive isotopes on transport.

- The medical establishment managers shall ensure the adequate supply of such means.

XI. INVESTIGATION OF MEDICAL RADIATION-RELATED ACCIDENTS CAUSED TO PATIENTS

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a) Conducting radiotherapy on the wrong patients, wrong parts, with wrong radioactive drugs and wrong doses with value remarkably different from the value prescribed by doctors.

b) The radio diagnostic dose is much greater than the prescribed level or the repeated radio diagnostic dose greatly exceeds the prescribed level.

c) Any damage of equipment, any accident, accidental errors and all other contingencies which may expose the patients to radiation doses in great excess of the prescribed level.

2. After investigating the above-said incidents, the radiation section managers shall have to:

a) Organize the recalculation or re-evaluation of doses received from patients.

b) Work out remedial measures to treat and save the patients and to prevent re-occurence of incident.

c) Immediately report in writing to the superior agencies after investigating and making conclusion on the causes of the incidents. In case of serious consequences, to report them to the Radiation and Nuclear Safety Board of the Ministry of Science, Technology and Environment.

d) Inform patients of the incidents.

XII. ARCHIVE

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a) In radioactive diagnosis: necessary information (electric voltage, electric current, duration) for subsequent evaluation of doses, including the number of radioscopies, the date of radioscopy and/or photography.

b) In nuclear medicine: Assorted radioactive drugs already used and their radioactive intensity, their use date.

c) In radiotherapy: Description of radiated areas, dose at focal point of the radiated area, doses at other related organs, the number of radioscopies, the date of radioscopy.

2. The radiation sections shall have to keep the results of machine rectification, periodical examinations, relevant physio-parameters selected in radiotherapy for at least five years.

3. The duration of archiving health records and standard dose records of radiation personnel shall comply with the provisions at Clause 5, Article 9 of Decree No.50/1998/ND-CP of July 16, 1998 of the Government.

XIII. ORGANIZATION OF IMPLEMENTATION

1. The Science, Technology and Environment Services of the provinces and centrally-run cities shall perform the State management function in supervising and inspecting the observance of radiation safety at radiation sections in their respective localities.

2. The radiation sections which have already put into operation or are storing or using radiation equipment, closed radioactive sources, open radioactive source and/or radioactive wastes before the issuance of this circular, shall, within 90 days after the circular takes effect, have to fill in the procedures for declaration, then the procedures to apply for the permits as provided for at Section III of this Circular.

Pending the granting of permits, such radiation sections may continue using the above-mentioned radiation equipment and radioactive substances.

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3. The Health Ministry shall nominate medical examination and treatment establishments to monitor the health of patients who have been over-X rayed and suffered from disease caused by radiation.

4. After the private and/or foreign-invested radiation establishments obtain all radiation safety permits as provided for in Section III of this Circular, the Health Ministry or the provincial/municipal Health Services shall consider the granting of certificates of law-prescribed qualifications and conditions for the practice of private medical and pharmaceutical occupations as well as for foreign-invested medical examination and treatment.

XIV. IMPLEMENTATION EFFECT

This Circular takes effect 15 days after its signing

Any problems arise in the course of implementation should be promptly reported to the two ministries for settlement.

FOR THE MINISTER OF SCIENCE, TECHNOLOGY AND ENVIRONMENT
VICE MINISTER




Hoang Van Huay

FOR THE HEALTH MINISTER
VICE MINISTER





Le Ngoc Trong

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 Radiation danger signboard

The signboard is in triangle (with size, scales inscribed in the drawing).

D- (diameter of a circle between the three sides).

The circle, the three sides and the edge frame are in red on yellow background. Letters inscribed in the notice box are in black on white background. (clearly inscribed: X ray or radioactive rays).

APPENDIX 6

The maximum radioactive intensity for discharged patients who have been treated with radioactive pharmaceuticals

Radioactive nuclide

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Iode 131

1100

FOR THE MINISTER OF SCIENCE, TECHNOLOGY AND ENVIRONMENT
VICE MINISTER




Hoang Van Huay

FOR THE HEALTH MINISTER
VICE MINISTER





Le Ngoc Trong