This standard specifies the quality control of radiation sterilization and disinfection of disposable medical supplies (including sanitary products). This standard applies to all factories producing disposable medical supplies and units that perform radiation sterilization and disinfection. GB 16383-1996 Quality Control Standard for Radiation Sterilization and Disinfection of Medical and Sanitary Products GB16383-1996 Standard download decompression password: www.bzxz.net

National Standard of the People's Republic of China
Radiation sterilization of medical and hygienical products
Quality control standards for radiation sterilizationof medical and hygienical productsGB16383—1996
In order to implement the "Law on the Prevention and Control of Infectious Diseases and its Implementation Measures" and the "Disinfection Management Measures", realize the standardization of radiation sterilization and disinfection technology of medical supplies (including hygienical products), ensure the quality of radiation sterilization and disinfection products, and protect the health of the people, this standard is specially formulated. 1 Subject content and scope of application
This standard specifies the quality control of radiation sterilization and disinfection of disposable medical supplies (including hygienical products). This standard applies to all factories producing disposable medical supplies and units that carry out radiation sterilization and disinfection. 2 Reference standards
JJG591 Radiation source (for radiation processing) GB139 Standard method for measuring absorbed dose in water using ferrous sulfate dosimeter GB8368--Disposable infusion set
Disposable blood transfusion set
GB8369
GB8703 Radiation protection regulations
3 Terms
3.1 Sterilization assurance level SAL
[The maximum probability that a product or component does not reach sterilization after sterilization of medical and health products and components. Depending on the purpose of the product, SAL ranges from 10\ to 10-6.
3.2 Absorbed dose DwwW.bzxz.Net
Absorbed dose D is the quotient obtained by dividing dE by dm, where dE is the average energy imparted by ionizing radiation to a mass of dm. dE
The unit of absorbent address is joule/dry gram, the special name is gray [ray], and the symbol is Gy. 1 gray is equal to 1 joule of energy absorbed per kilogram of material, that is, 1 Gy is equal to 1 J·kg-1.
3.3 Absorbed dose non-uniformity U
Absorbed dose non-uniformity U refers to the quotient of the maximum absorbed dose (Dmax) measured at different parts of the irradiated product box divided by the minimum absorbent t (min).
3.4 ​​Initial contamination bacteria count
When sterilization is about to be carried out. The total number of microorganisms living on a medical product or component. 3.5 Value
Approved by the State Administration of Technical Supervision on May 23, 1996 466
(2)
Implemented on December 1, 1996
GB16383-1996
The D value is the absorbed dose required for the total number of surviving bacteria to be reduced to one tenth of the original total number of bacteria after radiation treatment. 3.6 Biological indicator tablets
Test tablets with a certain number of strains with strong radiation resistance (the indicator bacteria is Bacillus pumilus E6o1). 3.7 Reference dosimeter
A dosimeter with the highest accuracy and stability developed by a national laboratory. A reference dosimeter that can reproduce the absorbed dose unit in an absolute way, has the highest dosimetric performance, and has been identified and approved by the state as the highest basis for the unified national absorbed dose unit value. 3.8 Standard dosimeter
Has good dose performance and has passed the assessment in accordance with the law. It can be used to calibrate radiation fields and calibrate working dosimeters. Its value can be traced back to the national reference dosimeter and calibrated by the reference dosimeter. 3.9 Working dosimeter
A dosimeter calibrated by a standard dosimeter, used to calibrate the radiation field dose rate and measure the absorbed dose of the product, and conduct routine dose monitoring.
3.10 Sterilizer
The absorbed dose required for medical supplies to be irradiated when the required sterilization assurance level is achieved. 4 Requirements for radiation sterilization and disinfection quality
4.1 Medical supplies (including sanitary products) should meet the following requirements before radiation sterilization 4.1.1 Medical supplies manufacturers must strictly implement the requirements of civilized production (GMP). Product packaging and sealing are intact. 4.1.2 Medical supplies and packaging materials should be materials that can withstand radiation sterilization doses. 4.2 Requirements for radiation sterilization and disinfection units
4.2.1 The irradiation facilities of radiation sterilization and disinfection units must meet the requirements of JJG591 and GB8703 and obtain a radiation safety certificate. The dose-based monitoring instruments used must be calibrated regularly in accordance with national regulations. Operators must hold a job technical assessment certificate. 4.2.2 The products to be irradiated should fill the irradiation box as evenly as possible, and the unevenness of the absorbed dose should be less than 1.5. 4.2.3 The storage warehouses for products to be sterilized by radiation and the storage warehouses for sterilized products should be strictly separated. 4.3 Provisions for sterilization and disinfection doses and sterilization assurance levels 4.3.1 Based on the initial number of contaminated bacteria N for each batch of products. , sterilization assurance level SAL and indicator bacteria Di. value, determine the sterilizer SD according to formula (3):
SD kDrolog SAL
Where: k—safety factor,>1, according to my country's situation, k=1.4. (3
4.3.2 Sterilization of medical supplies means that its sterilization assurance level must reach 10-6, and the minimum sterilization dose must not be less than 20kGy. Disinfection of sanitary products means that its sterilization assurance level must reach 10-3, and the minimum disinfection dose must not be less than 12kGy. 4.3.3 Under the condition of meeting product standards, the sterilization unit should ensure the sterilization quality. A sterilization or disinfection qualified report signed by the radiation sterilization duty officer and the duty supervisor should be provided for each batch of sterilized or disinfected products. 5 Product radiation treatment
5.1 Absorbed dose measurement base
5.1.1 The dose base meter used by the radiation sterilization unit must be calibrated. 5.1.2 Standard dosimeter (such as ferrous sulfate) Operate in accordance with GB139 and calibrate with the reference dosimeter once a year. 5.1.3 The working dosimeter can only be used after being calibrated with the standard dosimeter, and it must be calibrated with the standard dosimeter regularly. 5.2 Determination of initial contamination bacteria
At least 10 samples shall be randomly selected from each production batch of products. The average number of initial contamination bacteria in each batch of samples shall meet the requirements of Article 4.1. 5.3 Sterilization effect inspection
GB16383-1996
5.3.1 Use a working dosimeter to measure the radiation absorption dose of the product. The absorption dose and the unevenness of the dose distribution shall be measured in accordance with JJG591.
5.3.2 No less than 10 biological indicator bacteria tablets shall be used. Place them randomly at a ratio of 1:10, and place three indicator bacteria tablets with a bacterial load of 10°CFU in the area with the minimum absorbed dose in the product box (or irradiation box). After irradiation, take them out for sterility test. If the culture of each indicator bacteria tablet is negative, it is judged as qualified for sterilization; if one of the bacteria tablets is positive, it is judged as unqualified. The sterilization assurance level required by the product must be achieved after irradiation. 5.3.3 Physical and chemical performance inspection of the product shall be carried out in accordance with the requirements of GB8368 and GB8369 or corresponding standards when necessary. 6 Management of medical and health products after radiation sterilization (disinfection)
6.1 Radiation color-changing sheets and sterilization (or disinfection) certificates should be affixed to the packaging boxes of medical supplies after radiation sterilization (disinfection). The certificate should have the batch number, sterilization date, sterility validity period, and sterilization unit. 6.2 Products after radiation sterilization (disinfection) should be accompanied by a leaflet on the radiation sterilization (disinfection) process, signed by the sterilization (disinfection) operator. The product code, manufacturing batch number, and number of product units must be consistent with the inventory records. 6.3 After the product is irradiated, the packaging must be intact and the dose monitoring results must meet the requirements of the irradiation process. Otherwise, it should be scrapped or re-irradiated.
6.4 After the product is irradiated, if the packaging and seal are damaged during transportation and storage, it should be scrapped. 168
A1 Initial contamination bacteria count inspection
CB 16383-1996
Appendix A
Initial contamination bacterial count inspection
(Supplement)
A1.1 For medical supplies with inner cavities, such as infusion (blood) syringes, dialyzers and various catheters, use quantitative eluent to rinse the inner cavity aseptically, rinse repeatedly, and shake thoroughly before sampling. A1.2 For spare parts of disposable infusion (blood) devices and other medical devices, such as connectors, drip buckets, protective sleeves, bottle stoppers, perforators, syringe jackets, core rods, rubber pistons, surgical blades, suture needles, threads, acupuncture needles, injection needles, etc., they can be directly rinsed with quantitative eluent (1mL/10cm2), the eluent can be spotted in a sterile container, and the sample can be taken after sufficient shaking. A1.3 For dressings, 10g can be taken aseptically, placed in 100mL sterile saline, and the sample can be taken after sufficient shaking. A1.4 Eluent formula: add 10g protein Chen, 801g Tween and 8.5g NaCl to 100mL sterile distilled water. A1.5 Test method and calculation results:
Take 5 replicates of each sample, and pour each sample on 2 plates for culture and counting.Count according to formula (A1): Number of bacteria
Per piece (or per gram)
A2 Common microorganisms D1 value
Bacillus megaterium IMF1166
Bacillus cereus BSA
Bacillus subtilis ATCC6633
Bacillus subtilis IAM1213
Bacillus subtilis (globigii)
Bacillus brevis Ero1
Bacillus coagulans
Clostridium botulinum 13
Escherichia coli
Pseudomonas aeruginosa
Staphylococcus aureus||tt| |Bacillus subtilis (globigii) (nutrition) Bacillus subtilis ((glohigi) TSH sprouts
Average bacterial count × dilution factor
Each piece or weight (g)
D (kGy)
(Al)
Additional instructions:
GB16383-1996
This standard was proposed by the Ministry of Health of the People's Republic of China. This standard was drafted by the Beijing Radiation Center. The main drafters of this standard were Zhou Ruiying, Qian Simin, Jin Yongling, and Li Fengmei. This standard is interpreted by the Ministry of Health's technical management unit, the Ministry of Health's Communicable Disease Prevention and Control Supervision and Management Office. 170
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