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HJ 1188-2021 English PDF

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HJ 1188-2021: (Nuclear medicine radiation and safety requirements)
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Standard similar to HJ 1188-2021

HJ 1347.1   HJ 1346.1   HJ 1198   

Basic data

Standard ID HJ 1188-2021 (HJ1188-2021)
Description (Translated English) (Nuclear medicine radiation and safety requirements)
Sector / Industry Environmental Protection Industry Standard
Word Count Estimation 13,188
Issuing agency(ies) Ministry of Ecology and Environment

HJ 1188-2021: (Nuclear medicine radiation and safety requirements)

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
(Nuclear medicine radiation and safety requirements) National Ecological Environment Standard of the People's Republic of China Nuclear Medicine Radiation Protection and Safety Requirements Radiation protection and safety requirements for nuclear medicine This electronic version is the official standard text, which is reviewed and typeset by the Environmental Standards Institute of the Ministry of Ecology and Environment. Published on 2021-09-06 2021-11-01 Implementation Released by the Ministry of Ecology and Environment directory Foreword...ii 1 Scope...1 2 Normative references...1 3 Terms and Definitions...1 4 General...1 5 Site selection and layout...3 6 Radiation safety and protection in the workplace...3 7 Management of radioactive waste...4 8 Radiation monitoring...7 Appendix A (Informative Appendix) Toxicity and Operation Modification Factors of Radionuclides Commonly Used in Nuclear Medicine...8 Appendix B (informative) Control of radionuclide activity in the patient at discharge...9 Appendix C (informative) Upper limit of radionuclide activity in cadavers that can be handled without special protective measures...10 Nuclear Medicine Radiation Protection and Safety Requirements

1 Scope of application

This standard specifies the use of radiopharmaceuticals in medical institutions to carry out clinical nuclear medicine diagnosis and treatment, experimental research and radiopharmaceutical preparation activities. radiation protection and safety requirements. This standard applies to the design and construction of nuclear medicine workplaces in medical institutions and the radiation protection and safety management of nuclear medicine-related activities.

2 Normative references

This standard refers to the following documents or clauses thereof. For dated references, only the dated version applies to this standard. For undated references, the latest edition (including all amendments) applies to this standard. GB 18871 Basic standard for ionizing radiation protection and radiation source safety

3 Terms and Definitions

The following terms and definitions apply to this standard. 3.1 nuclear medicine The application of radionuclides or radiopharmaceuticals for diagnosis, treatment of diseases, and medical research. 3.2 radiopharmaceutical Radionuclide preparations or labeled compounds for use in disease diagnosis, treatment, or clinical research. 3.3 medical radioactive waste Gaseous, liquid and solid waste containing or contaminated with radionuclides produced in nuclear medicine activities. 3.4 decay pool A container used to collect, store and discharge radioactive waste liquid in which the radioactive waste liquid decays naturally.

4 General

4.1 General requirements 4.1.1 The medical institution shall be fully responsible for the radiation protection and safety work of the nuclear medicine activities carried out, so as to realize the protection of radiation workers and public health. public and environmental goals. 4.1.2 The medical institution shall judge the legitimacy of the nuclear medicine activities to be carried out to ensure that the activities carried out are legitimate. 4.1.3 In the process of planning, designing and constructing nuclear medicine workplaces and carrying out nuclear medicine activities, the principle of optimization of radiation protection shall be followed, so that the The magnitude of the exposure to the relevant individuals involved in nuclear medicine activities, the number of people exposed and the likelihood of exposure are kept within reasonable limits. the lowest possible level. 4.1.4 The workplace where nuclear medicine activities are carried out shall implement hierarchical management. 4.1.5 The radiation workplace where nuclear medicine activities are carried out should be divided into control areas and supervision areas, and the workplace should be rationally laid out. Logistics, airflow paths, and proper collection, temporary storage and disposal of radioactive waste from nuclear medicine activities. 4.1.6 The medical institution shall conduct regular radiation monitoring and assessment in the workplace and surrounding environment where nuclear medicine activities are carried out, and prove that the Rationality of radiation protection and safety measures. 4.1.7 Medical institutions that carry out nuclear medicine activities shall formulate appropriate emergency plans for radiation accidents, and do a good job in emergency preparedness and response to radiation accidents. Make arrangements to effectively prevent radiation accidents or mitigate the consequences of radiation accidents. 4.2 Classification of radiation workplaces According to the provisions of GB 18871, the radiation workplaces shall be classified into Class A and Class B according to the daily equivalent maximum operating volume of radionuclides. and Class C. Please refer to Appendix A for the correction factors of toxicity and operation mode of radionuclides commonly used in nuclear medicine. 4.3 Radiation workplace zoning 4.3.1 The nuclear medicine workplace shall be divided into control area and supervision area according to the requirements of GB 18871, and shall be managed accordingly. 4.3.2 The control area of the nuclear medicine workplace mainly includes the cyclotron machine room, the radiopharmaceutical synthesis and packing room, and the radiopharmaceutical storage room. Storage room, dosing room, post-dosing waiting room, scanning room, radionuclide treatment ward, special toilet for post-dosing patients, temporary storage of radioactive waste, Decay pools, etc. 4.3.3 The supervision area of the nuclear medicine workplace mainly includes the cyclotron and imaging equipment control room, the sanitary passage room and the control area. other places or areas connected. 4.3.4 Standard ionizing radiation warning signs and signs indicating the control area should be set at the entrance of the control area, and signs should be set at the entrance of the supervision area. Supervised area sign. 4.4 Dose Limits and Dose Constraints 4.4.1 Dose Limits The occupational exposure dose limit of nuclear medicine workers shall comply with the relevant provisions of B1.1 in Appendix B of GB 18871.The practice of nuclear medicine makes public The dose exposure limits for members shall comply with the relevant provisions of B1.2 in Appendix B of GB 18871. 4.4.2 Dose constraints 4.4.2.1 In general, the dose constraint value of occupational exposure shall not exceed 5 mSv/a; 4.4.2.2 The dose constraint value for public exposure shall not exceed 0.1 mSv/a. 4.4.3 Level of radioactive surface contamination control The level of radioactive surface contamination control in nuclear medicine workplaces is implemented in accordance with GB 18871. 4.5 Discharge requirements for patients taking medication 4.5.1 In order to ensure that after the discharge of the radionuclide treatment patient, the family members and the public who are in contact with the patient will not exceed the relevant dose constraints. or dose limit, the radionuclide activity in discharged patients should comply with the relevant provisions of Appendix B. 4.5.2 In patients receiving iodine-131 treatment, the radioactivity in the body should be reduced to less than 400 MBq or at a distance of 1 meter from the patient's body surface. The patients were discharged from the hospital only when the peripheral dose equivalent rate was not greater than 25 μSv/h.

5 Site selection and layout

5.1 Site selection 5.1.1 The nuclear medicine workplace should be built in a separate building in a medical institution, or concentrated at one end or bottom of a building where no one lives for a long time. layer, set up corresponding physical isolation and separate personnel and logistics channels. 5.1.2 Nuclear medicine workplaces should not be adjacent to obstetrics, pediatrics, canteens and other departments and crowded areas, and should be clearly identified with non-radioactive workplaces. True demarcation. 5.1.3 The location of the exhaust vents in the nuclear medicine workplace should be as far away from the surrounding high-rise buildings as possible. 5.2 Layout 5.2.1 The nuclear medicine workplace shall be reasonably arranged, and the inpatient treatment site and the outpatient diagnosis site shall be arranged relatively separately; The layout of each functional area should be reasonably designed according to the diagnosis and treatment process, the control area should be relatively concentrated, and the high activity room should be concentrated at one end to prevent cross-contamination. Minimize the storage range of radiopharmaceuticals and radioactive wastes, and limit the movement space of patients after administration. 5.2.2 There should be relatively independent paths for staff, patients, radiopharmaceuticals and radioactive wastes in the nuclear medicine workplace. staff member The channel and the patient channel are separated to reduce the exposure of the patient to other personnel after administration. Patients after radiopharmaceutical injection and before radiopharmaceutical injection Patients do not intersect, personnel and radiopharmaceutical channels do not intersect, and the transport channels for radiopharmaceuticals and radioactive waste should be as short as possible. 5.2.3 Appropriate measures should be taken in the nuclear medicine workplace to control the random entry of unrelated personnel into the control area and the random flow of patients after administration. Avoid unnecessary exposure of workers and the public. Sanitary buffer zones should be set up at the entrances and exits of the control area to provide necessary facilities for staff and patients. Changes of clothing, protective equipment, flushing facilities, and surface contamination monitoring equipment are required. There should be dedicated toilets for patients after administration in the control area.

6 Radiation safety and protection in the workplace

6.1 Shielding requirements 6.1.1 The shielding layer design of the nuclear medicine site should be appropriately conservative, according to the maximum radioactivity, maximum time and shortest distance that may be used. line calculation. 6.1.2 When designing the shielding layers of the walls, floors and top surfaces of nuclear medicine workplaces, in addition to indoor radiation sources, adjacent The influence of radiation sources present in the area and exposure to scattered radiation. 6.1.3 The construction of the cyclotron room should avoid using concrete rich in iron minerals, and avoid using barite or iron in the concrete. Aggregate; cyclotrons without self-shielding should have a separate equipment room, and concrete materials that are not easily activated by neutrons should be selected for the machine room. 6.1.4 When the cable ducts, ventilation ducts, etc. of the cyclotron room pass through the shielding body, the trenches or S-type, V-type and Z-type shall be used to pass through the shielding body. wall, and perform shield compensation to ensure that the protection requirements outside the shield wall are met. The connection between the protective door and the wall should be effectively overlapped to avoid Weaknesses in protection appear. 6.1.5 The surrounding dose equivalent rate at a distance of 30 cm from the room protective door, observation window and outer surface of the wall in each control area of the nuclear medicine workplace shall be If it is less than 2.5 μSv/h, if the room outside the shielding wall is an equipment room where personnel occasionally stay, the surrounding dose equivalent rate should be less than 10 μSv/h. 6.1.6 Boxes, fume hoods, injection windows and other equipment for radiopharmaceutical synthesis and sub-packaging should be provided with shielding structures to ensure that the outer surface of the equipment is 30 cm The dose equivalence rate around the manned operating position is less than 2.5 μSv/h, and the radiopharmaceutical synthesis and distribution box is not facing the surface of the manned operating position. The ambient dose equivalent rate is less than 25 μSv/h. 6.1.7 Solid radioactive waste collection barrels, radioactive waste liquid collection tanks and pipelines that are exposed to the ground and accessible to personnel shall be provided with additional phases. Shielding measures should be taken to ensure that the surrounding dose equivalent rate at 30 cm of the outer surface is less than 2.5 μSv/h. 6.1.8 The radioactive material should be stored in a special place and should be properly shielded. 6.2 Requirements for site safety measures 6.2.1 The surface of the radionuclide operating equipment and the workbench in the nuclear medicine workplace shall be smooth and smooth, and the indoor floor shall be connected to the wall There should be no seams, easy to clean and decontaminate. 6.2.2 The operation of radiopharmaceutical sites whose level reaches level B should be carried out in a glove box, and level C can be carried out in a fume hood. to engage in radiation Staff in sex drug operations are equipped with necessary protective equipment. The radiopharmaceutical dispenser should be properly shielded, and the patient waiting room, Shielding bodies such as lead screens should be provided next to the beds in the radionuclide treatment ward to reduce exposure to other patients and medical staff. 6.2.3 The exit of the control area for operating radiopharmaceuticals should be equipped with surface contamination monitoring instruments, and personnel and items leaving the control area should be inspected. Surface contamination monitoring, if the surface contamination level exceeds the control standard, corresponding decontamination measures should be taken. 6.2.4 Radioactive substances should be stored in storage containers or safes in special places, and the radiation level should be monitored regularly. enter. Stored radioactive substances should be established in a ledger and registered in a timely manner to ensure that the accounts are consistent. 6.2.5 Storage and transfer containers with sufficient shielding should be provided for the transport of radioactive materials in the nuclear medicine workplace, and the surface of the container should be stretched. The ionizing radiation sign shall be affixed, and the container shall have appropriate fixing measures during transportation. 6.2.6 The implantation site of the seed source should be equipped with radiation monitoring equipment. After the operation, the radiation level of the operating bed and surrounding areas should be monitored. To rule out omission or loss of the seed source during surgical implantation. 6.2.7 A special treatment room should be set up in the treatment site of the applicator, and it is strictly forbidden to take the applicator source out of the treatment room during treatment. In patch therapy, medical Personnel should take effective personal protective measures, and appropriate shielding measures should be used for the normal tissue of the patient. Sharps should be avoided when using the applicator If the surface of the source window is damaged, the applicator should not be immersed in water, alcohol and other solvents, and should be stored in a dry source box after use. 6.2.8 The cyclotron machine room shall be provided with door machine interlocking device and delayed door opening measures, and emergency stop switch and emergency door opening shall be provided in the machine room button and clearing measures, and install a fixed dose rate alarm. There should be sound and light alarm devices and working status indicators at the door of the computer room, and should be connected with the Gear interlock. 6.2.9 The working status indicator should be set above the outer door frame of the scanning machine room. 6.3 Containment and ventilation requirements 6.3.1 The nuclear medicine workplace should be well ventilated, and the airflow direction of the workplace should follow the self-cleaning area to the supervision area and then to the control area. The direction of the design is to maintain the negative pressure of the workplace and the pressure difference between the various areas to prevent the cross-section of radioactive gases and aerosols in the workplace. pollute. 6.3.2 The workplace where the cyclotron is used to prepare radiopharmaceuticals shall be provided with a separate ventilation system, and there shall be a single ventilation system in the self-shielded area of the accelerator. It has a separate exhaust pipe and is in a negative pressure state relative to the accelerator chamber. 6.3.3 The iodine-131 treatment ward should be equipped with a separate ventilation system, and the doors and windows of the ward should be closed to maintain negative pressure in the treatment area. The air in the treatment area should be systematically discharged through a separate exhaust duct. 6.3.4 The synthesis, sub-packaging of radioactive materials and the operation of volatile radionuclides should be carried out in closed equipment such as glove boxes and fume hoods. Prevent leakage of radioactive liquids or escape of radioactive gases and aerosols. Glove boxes, fume hoods and other closed equipment should be designed with a separate exhaust system. And install activated carbon or other filtering devices on the top wall of the closed equipment. 6.3.5 The fume hood should have sufficient ventilation capacity. Cyclotron working areas for the preparation of radiopharmaceuticals, iodine-131 treatment wards, and facilities The exhaust outlet of the ventilation system in places such as fume hoods and glove boxes should be higher than the roof of the building and as far away from the adjacent high-rise buildings as possible.

7 Management of radioactive waste

7.1 General requirements 7.1.1 According to the form of waste generated in nuclear medicine practice and the type, half-life, activity level and physicochemical properties of radionuclides in it The radioactive wastes shall be collected and treated separately according to the requirements of classification of radioactive wastes. 7.1.2 The radioactive waste and the de-controlled waste should be distinguished according to the principle of waste minimization, and they should not be mixed and treated, and the radioactive waste should be controlled and reduced as much as possible. Sexual waste generation. 7.1.3 The short-lived radioactive wastes generated in the practice of nuclear medicine should be treated by storage decay methods as far as possible. After the activity concentration meets the de-control level, de-control is implemented. Radioactive waste that cannot be released from control shall be sent to qualified radioactive waste storage or disposal agency to process. 7.1.4 A management ledger for the collection, storage and discharge of radioactive waste shall be established, and records shall be kept and archived. 7.2 Management of Solid Radioactive Waste 7.2.1 Solid radioactive waste collection 7.2.1.1 Solid radioactive waste should be collected in special waste bins with shielding structures and ionizing radiation signs. Dedicated waste bins should be placed in Plastic bags directly store waste. 7.2.1.2 The radioactive waste with spikes and edges should be packaged in advance, and then put into waste buckets to prevent the waste bag from being punctured. 7.2.1.3 The weight of each bag of radioactive waste shall not exceed 20 kg. Plastic bags full of waste should be sealed and transferred to the radioactive waste temporary storage room in time storage. 7.2.2 Solid radioactive waste storage 7.2.2.1 Units that generate a small amount of radioactive waste and dispose of radioactive waste by storage decay may, upon approval by the examination and management department, dispose of the waste. Temporary storage in licensed places and special containers. The temporary storage time and total activity cannot exceed the limit requirements approved by the audit and management department. 7.2.2.2 The radioactive waste storage site should be equipped with ventilation and ventilation devices. If the radioactive waste contains volatile radionuclides, the ventilation should be changed. The air device should have a separate exhaust duct. Ionizing radiation warning signs should be set up at the entrance, and effective fire prevention, loss prevention, and radiation leakage prevention measures should be adopted. and other measures. 7.2.2.3 Special containers should be set up in the waste temporary storage room to hold solid radioactive waste bags (buckets), and different types of waste should be stored separately. container The name of the nuclide contained in the waste, the type of the waste, the date of storage and other information should be marked on the surface, and the registration record should be made. 7.2.2.4 The radioactive experimental animal carcasses or organs should be put into waste bags to take antiseptic measures (such as stored in a special freezer), and be properly prepared. Shield protection. See Appendix C for the upper limit of common radionuclides contained in cadavers that can be handled without special protective measures. 7.2.2.5 Inflammable, explosive and corrosive items shall not be stored in the temporary waste storage room. 7.2.3 Solid radioactive waste treatment 7.2.3.1 If the temporary storage time of solid radioactive waste meets the following requirements, the monitored radiation dose rate meets the background level of the environment, and the α surface If the pollution is less than 0.08 Bq/cm2 and the β surface pollution is less than 0.8 Bq/cm2, the waste can be cleaned and controlled and treated as medical waste. a) The radioactive solid waste containing nuclides with a half-life of less than 24 hours is temporarily stored for more than 30 days; b) The temporary storage time of radioactive solid waste containing nuclides with a half-life of more than 24 hours exceeds 10 times the longest half-life of the nuclide; c) The radioactive solid waste containing iodine-131 nuclide is temporarily stored for more than 180 days. 7.2.3.2 The radioactive solid waste that cannot be released from control shall be collected and prepared in accordance with the relevant regulations on radioactive waste treatment, and sent to the relevant authorities. Qualified unit processing. The surface dose rate outside the radioactive waste packaging should not exceed 0.1 mSv/h, and the surface contamination level has a significant impact on β and γ emission. Alpha emitters and low toxicity alpha emitters should be less than 4 Bq/cm2, other alpha emitters should be less than 0.4 Bq/cm2. 7.2.3.3 The storage and treatment of solid radioactive waste shall be assigned to a special person, and a waste storage and treatment ledger shall be established to record the radiation in detail. Information such as the name of the nuclide, the weight, the start date of the waste generation, the responsible person, the time of leaving the warehouse, and the monitoring results of the sexual waste. 7.3 Management of liquid radioactive waste 7.3.1 Collection of radioactive waste 7.3.1.1 The nuclear medicine workplace shall be provided with a trough or plug-flow radioactive waste liquid decay pool or special container for collecting radiopharmaceuticals. Radioactive waste liquid produced in places such as rooms, radionuclide treatment wards, toilets of patients after drug administration, toilet passage rooms, etc. radioactive waste. 7.3.1.2 The residual liquid and other waste liquid containing radionuclides should be collected after radiopharmaceutical labeling, sub-packaging and injection in the nuclear medicine workplace in a dedicated container. Radioactive waste containing long half-life nuclides should be collected and stored separately. The surface of the container containing the radioactive waste liquid should be posted with electricity Ionizing radiation sign. 7.3.1.3 Decontamination and treatment equipment (including decontamination solution) shall be provided for the water supply in the nuclear medicine workplace. Shower room in the control area and toilet pass room, Wash basins, cleaning pools, etc. should use foot-operated or automatic inductive switches to reduce radioactive contamination of equipment in the site. head, eyes and face It is advisable to use flowing water that showers upwards. 7.3.1.4 The direction of the pipeline for the collection of radioactive waste, the connection of valves and pipelines should be designed to have as few dead zones as possible, and the sewers should be short and large. Water flow pipes should be marked to avoid accumulation of radioactive waste and facilitate detection and maintenance. 7.3.2 Storage of radioactive waste liquid 7.3.2.1 The radioactive waste liquid collected in the decay tank and special container shall be stored until the discharge requirements are met. Volume of decay pool or special container Full consideration should be given to the half-life of radiopharmaceuticals handled in the site, the amount of waste liquid expected to be stored in routine nuclear medicine diagnosis and treatment and research, and events. Therefore, it is necessary to clean in an emergency; the body of the decay tank should be firm, resistant to acid and alkali corrosion, non-permeable, smooth inner wall and have reliable anti-leakage measures. 7.3.2.2 The nuclear medicine workplace of the treatment ward containing iodine-131 shall be provided with a trough-type waste liquid decay pool. The trough-type waste liquid decay tank should be composed of sludge tank and It consists of trough-type decay tanks. The body of the decay tank is designed as two or more trough-type tanks, which alternately store, decay and discharge waste liquid. on the waste pool Default sampling port. There are measures to prevent waste liquid from overflowing, sludge hardening and deposition, clogging of water inlet and outlet, and overpressure of waste liquid decay pool. 7.3.2.3 For nuclear medicine diagnosis and outpatient iodine-131 treatment places, a push-flow radioactive waste liquid decay pool can be set up. The plug-flow decay cell should include Sludge tank, decay tank and detection tank. Effective measures should be taken to ensure that the radioactive waste liquid is filtered through the sludge tank to precipitate solids, and pushed to the decay tank. The decay cell body is divided into 3-5 grades of continuous decay pools, and a diversion wall is installed in the pool. The bottom of the sludge tank has a mechanism to prevent and remove the sludge hardening and deposition. measure. 7.3.3 Radioactive waste liquid discharge 7.3.3.1 For the storage method of trough decay cell. a) The radioactive waste liquid containing the half-life of nuclides less than 24 hours can be released directly after being temporarily stored for more than 30 days; b) The temporary storage time of radioactive waste liquid containing nuclide half-life is more than 24 hours is more than 10 times the longest half-life (temporary half-life containing iodine-131 nuclide storage for more than 180 days), after the monitoring results are approved by the audit and management department, the discharge shall be carried out in accordance with the provisions in 8.6.2 of GB 18871.radioactive waste The total α of the total liquid discharge outlet is not more than 1 Bq/L, the total β is not more than 10 Bq/L, and the radioactive activity concentration of iodine-131 is not more than 10 Bq/L. 7.3.3.2 For the storage method of the plug-flow decay pool, if the half-life of the contained nuclide is greater than 24 hours, the radioactive waste in the decay pool shall be dealt with every year. The radioactivity concentration of iodine-131 and the longest half-life nuclide shall meet the requirements of Table A1 of Appendix A of GB 18871. 7.3.3.3 The temporary storage and treatment of radioactive waste liquid shall be assigned to a special person, and a waste temporary storage and treatment ledger shall be established to record the radioactive waste in detail. The name and volume of the nuclide contained in the liquid, the start date of waste liquid generation, the responsible person, the discharge time, monitoring results and other information. 7.4 Management of gaseous radioactive waste 7.4.1 Nuclear medicine sites that generate gaseous radioactive wastes should be set up with independent ventilation systems to rationally The gas in the workplace is filtered and purified to avoid contamination of the workplace and the environment. 7.4.2 The effectiveness of the filter and purifier in the ventilation system should be checked regularly, and the failed filter should be replaced in time. The replacement cycle should not exceed the manufacturer's recommendation. recommended usage time. The replaced filters are collected and disposed of as radioactive solid waste.

8 Radiation Monitoring

8.1 General requirements 8.1.1 Medical institutions that carry out nuclear medicine diagnosis and treatment practice shall formulate radiation monitoring plans, and implement monitoring work according to the plan. Units with monitoring capabilities may entrust capable units to conduct monitoring. 8.1.2 All radiation monitoring records should be archived and kept, and the measurement records should include measurement objects, measurement conditions, measurement methods, measurement instruments, Information such as when and who was measured. 8.1.3 Shall...

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