This standard specifies the basic requirements for radiation protection during the production (including research and development) and use of radioimmunoassay kits, as well as storage, transportation, and distribution. This standard applies to units and individuals engaged in the above practices of radioimmunoassay kits. GBZ 136-2002 Hygienic Protection Standard for the Production and Use of Radioimmunoassay Reagents (Kits) GBZ136-2002 Standard Download Decompression Password: www.bzxz.net

Ics13.100
National occupational health standard of the People's Republic of China GBZ136-2002
Sanitary protection standard for the production and use of radioimmunoassay kits
Radiological protection requirements for the productionand use of radioimmunoassaykit2002-04-08 Issued
Ministry of Health of the People's Republic of China
Implementation on 2002-06-01
Normative reference documents
Terms and definitions
Protection requirements for production units
Protection requirements for storage, transportation and distribution
Protection requirements for user units
Contents and cycles of routine monitoring (informative appendix) Appendix A
This standard is formulated in accordance with the Law of the People's Republic of China on the Prevention and Treatment of Occupational Diseases. The original standard WS181-1999 will be invalidated from the date of implementation of this standard
Chapter 46 of this standard is mandatory content, and the rest is recommended content. Appendix A of this standard is an informative appendix
This standard is proposed and managed by the Ministry of Health.
The drafting unit of this standard is Beijing Huaqing Company of China Nuclear Industry. The main drafters of this standard are Zhang Yongxiang, Li Guangqian and Sun Dongsheng. The Ministry of Health is responsible for the interpretation of this standard.
Standard for health protection in the production and use of radioimmunoassay reagents (kits)
1 Scope
GBZ136-2002wwW.bzxz.Net
This standard specifies the basic requirements for radiation protection in the production (including research and development) and use of radioimmunoassay kits as well as storage, transportation and distribution
This standard applies to units and individuals engaged in the above practices of radioimmunoassay kits. 2 Normative references
The clauses in the following documents become the clauses of this standard through reference in this standard. For all dated referenced documents, all subsequent amendments (excluding errata) or revised versions are not applicable to this standard. However, parties to an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For undated referenced documents, the latest versions shall apply to this standard.
GB/T7161
GB8703
GB9133
3 Terms and definitions
Identification and certificate of unsealed radioactive materials
Radiation protection regulations
Classification of radioactive waste
The following terms and definitions apply to this standard. 3.1 Radioimmunoassay kit Radioimmunoassay kit refers to a complete set of components (including operating instructions) that assembles standard products, markers, binding reagents, separation agents and buffer solutions. According to the principle of radioimmunoassay, this complete set of components can be used to determine the amount of a certain ultra-trace biologically active substance in vitro and can achieve a certain degree of precision or accuracy. It is referred to as radioimmunoassay kit. 4 Protection requirements for production units
4.1 General principles
4.1.1 The unit producing radioimmunity test kits is an open radiation work unit. Its classification and the grading of its workplace and the requirements for radiation health protection shall be implemented in accordance with GB8703
4.1.2 The unit producing radioimmunity test kits must apply for radiation health license registration in accordance with relevant regulations. 4.1.3 The radiation protection and supervision and management requirements of the unit producing radioimmunity test kits in practice shall comply with the relevant laws and regulations and standards of my country.
4.2 Protection requirements for operation
4.2.1 The workplace for producing radioimmunity test kits shall be managed in different areas in accordance with relevant regulations to prevent cross contamination. 4.2.2 The operation procedures and safety regulations shall be strictly followed when operating open radioactive materials. If necessary, the skills shall be mastered through "simulated operation" in advance. New operations or operations that may cause accidents shall be carried out under the supervision of protection personnel. 4.2.3 Operations such as bottle opening, transfer, labeling, separation and purification that are prone to the release or scattering of radioactive materials, when the activity of the radioactive materials in the operation reaches the level of Class B workplaces, must be carried out in a fume hood or work box with appropriate negative pressure. 4.2.4 Operations on liquid radioactive materials should be carried out in a sugar porcelain plate placed on a workbench that is easy to remove contamination, and covered with absorbent materials.
4.2.5 The operation of sucking liquids must be carried out with appropriate utensils, and sucking by mouth is strictly prohibited. 4.2.6 Operations accompanied by external irradiation should make full use of the three major protection factors of shielding, distance and time, and take corresponding protective measures. 4.2.7 Workers who operate radioactive materials should correctly wear the necessary personal protective equipment. It is not allowed to directly touch radioactive materials with bare hands or operate contaminated objects. 4
4.2.8 After radioactive operations, the workbench, equipment, floor and personal protective equipment should be inspected, cleaned and decontaminated for surface contamination. Workers should take a shower.
4.2.9 Eating, drinking, smoking and storing food in radioactive workplaces are strictly prohibited. 4.2.10 The control level of surface radioactive material contamination shall be implemented in accordance with Article 3.1.4 of GB8703 Radiation Protection Regulations. 4.3 Protection requirements for radioactive sources (liquids)
4.3.1 The radioactive sources (liquids) used in the production of radioimmunoassay kits shall be managed by a dedicated person and a system of storage, use, cancellation and regular inspection shall be established.
4.3.2 The containers of radioactive sources (liquids) must have obvious labels: indicating the name of the nuclide, physical and chemical state, activity level, storage start date and person in charge, etc.
4.3.3 Measures should be taken to prevent damage, leakage and contamination spread of the containers of radioactive sources (liquids). 4.3.4 After use, the radioactive source (liquid) should be stored in a special cabinet in a timely manner, which must be anti-theft, waterproof and fireproof, and there should be an ionizing radiation sign outside the cabinet.
4.4 Collection, disposal and treatment of radioactive waste 4.4.1 Necessary measures should be taken to minimize the amount of radioactive waste generated during the production of radioimmunoassay kits. It is strictly forbidden to mix radioactively contaminated waste with general waste. The classification of radioactive waste should be carried out in accordance with GB9133. 4.4.2 The discharge of radioactive airborne waste should be carried out in accordance with Article 4.3 of GB8703. 4.4.3 Radioactive liquid waste should be collected in containers that can prevent damage and leakage and placed in temporary storage rooms for decay. The discharge of low-level waste liquid less than or equal to 3.7×10°BqL should be carried out in accordance with Article 4.4 of GB8703. 4.4.4 Radioactively contaminated solid waste shall not be thrown or placed randomly. It should be collected in time and placed in containers according to the length of the half-life of the contaminated nuclides or whether they are flammable or not, and sealing measures should be taken. It is strictly forbidden to mix liquid waste and corrosive substances into it. Depending on the situation, it should be sent to the designated waste warehouse or placed in the temporary storage room for disposal according to relevant requirements. According to the measurement of the radiation protection department, radioactive contaminated solid waste with a specific activity less than 7.4×10*Bqkg can be treated as non-radioactive solid waste. 4.4.5 Waste temporary storage rooms should have ventilation measures and ionizing radiation signs. 4.5 Radiation protection monitoring
4.5.1 Production units should formulate monitoring implementation plans based on relevant protection standards and regulations combined with the specific characteristics of their units. Appendix A gives the content and cycle of routine monitoring in the workplace. 4.5.2 Production units should have necessary monitoring instruments, meters and full-time (part-time) radiation protection personnel. 4.5.3 The monitoring work should be recorded and filed comprehensively, carefully and in detail. 4.5.4 Regular evaluations should be conducted based on the monitoring results to continuously improve and perfect radiation protection work. 5 Protection requirements for storage, transportation and distribution
5.1 Packaging and marking of radioimmunoassay kits
5.1.1 Radioimmunoassay kits should have anti-extrusion, anti-vibration, anti-breakage and leakage and certain shielding effectiveness measures. 5.1.2 The level of radioactive contamination on the surface of the radioimmunity test kit should be less than 4×10-Bgcm2. The dose equivalent rate at any point 0.1m from the surface of the radioimmunity test kit should be less than 1μSv·hl. 5.1.3
The radioimmunity test kit must be attached (adhered or printed) with a non-sealed radioactive material identification certificate, and the requirements shall be implemented in accordance with GB/T7161.
5.2 Storage
The production and distribution of radioimmunity test kits should have a storage warehouse (room). There should be an ionizing radiation sign on the warehouse door. Inflammable, explosive and corrosive dangerous goods shall not be stored in the storage warehouse, and fire prevention, waterproof and anti-theft measures shall be provided. 5.2.2
5.2.3 A dedicated person shall be responsible for safekeeping. A registration system shall be established to ensure that the accounts and materials of the outgoing and incoming warehouses are consistent. 5.3 Transportation
5.3.1 During the transportation of radioactive sources (liquids) and radioimmunity test kits in the city, they should be delivered by a dedicated person to prevent loss. 5
5.3.2 When radioimmunity test kits are checked in, other items are not allowed to be mixed in the bag. 5.3.3 Radioimmunity test kits marked with 1251 can be mailed if the total activity of each kit does not exceed 2×10Bq. If it exceeds, it will be checked in as a radioactive material bag
5.4 Distribution
5.4.1 The radioimmunity test kits distributed must comply with the requirements of Article 5.1. 5.4.2 The distributor shall register for permission or apply for registration according to Article 6.1, depending on the level of radioactivity involved in its distribution. Protection requirements for users
6.1 General principles
6.11 When using radioimmunity kits, if the level of radioactivity involved exceeds the lower limit of the classification and grading of open radiation work units and their workplaces, the user must apply for radiation health license registration as required and follow the health protection requirements and supervision and management of open radiation work units.
6.1.2 When using radioimmunity kits, if the radioactive materials involved are less than the lower limit of the classification and grading mentioned in Article 6.1.1, the user may be exempted from license registration, but must apply for registration with the radiation health protection department. 6.2 Protection requirements for use
6.2.1 The use of radioimmunity kits should be carried out in a separate room. There should be an ionizing radiation sign at the door of the room. To prevent the spread of contamination, unrelated personnel and items are not allowed to enter. 6.2.2 Personnel who use and operate radioimmunity kits should undergo occupational health training and have the corresponding skills and protection knowledge. 6.2.3 Before using the radioimmunoassay kit, an appearance inspection is required. If any signs of leakage or contamination are found, the kit should be discontinued. If necessary, the relevant departments should be informed, the cause should be investigated and further treatment should be carried out. 6.2.4 Operations should be carried out on designated workbenches or in sugar porcelain trays, and necessary and feasible anti-contamination measures should be taken. 6.2.5 Operators should wear personal protective equipment and avoid direct skin contact with radioactive substances. 6.2.6 After the operation, the supplies should be cleaned up in time and stored properly. Supplies that have been in contact with radioactive substances shall not be used for other purposes without being measured by the radiation protection department.
6.2.7 A special cabinet should be prepared and locked for storing radioimmunoassay kits, and the cabinet door should have an ionizing radiation mark. 6.2.8 A dedicated person should be responsible for the collection, inventory and consumption accounts of radioimmunoassay kits. 6.3 The collection, disposal and treatment of radioactive contaminated solid waste shall be implemented in accordance with Article 4.4.4. 6
Appendix A
(Suggested Appendix)
Contents and cycles of routine monitoring
Table A1 is the contents and cycles of routine monitoring in the workplaces producing radioimmunoassay kits. Routine monitoring contents and cycles
Monitoring contents cycle
Workplace level
Personal dose
One month
Three months
Three months
Surface contamination
One month
Two months
Three months
Workplace
Airborne concentration
One month
Two months
Three months
Radiation level
One month
Two months
Three months
Effluent
Three months
Three months
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