GB/T 31995-2015 in English
VALIDSterilization of health care products―Radiation―Substantiation of a selected sterilization dose method VDmax
- Issued on:2015-09-11
- Implemented on:2016-04-01
- File Format:PDF
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《GB/T 31995-2015医疗保健产品灭菌 辐射 证实选定的灭菌剂量 VDmax方法》由TC58（全国核能标准化技术委员会）归口，TC58SC4（全国核能标准化技术委员会放射性同位素分会）执行，主管部门为国家标准化管理委员会。
本标准规定了辐射灭菌使医疗保健产品达到10-6无菌保证水平的选定的灭菌剂量的证实和剂量审核方法。
本标准适用于整个产品单元的平均生物负载符合选定剂量所要求的平均生物负载范围的医疗保健产品。
Introduction
Analysis of the core content of the standard
| Key elements | Technical requirements | Implementation points |
|---|---|---|
| Scope of application | Health care products with an average bioburden that meets a specific range | The product bioburden must be measured in advance and matched to the corresponding sterilization dose range |
| Sterilization dose gradient | 15kGy~35kGy (9 optional doses) | Select a dose that matches the bioburden according to Table 3 |
| Verification dose experiment | 10 samples irradiated with a SAL 10^-1 dose | If the number of positives is ≤1, it is passed; if it is 2, retest is required; if it is ≥3, the dosage needs to be re-established. |
Product family management specifications
The standard requires that product families be divided according to the number and type of microorganisms, and the following should be considered:
- Consistency between raw material sources and production processes
- Level of production environment control
- Biological burden distribution characteristics (batch-to-batch difference ≤ 2 times the total average)
Representative product selection priority: Main product > Equivalent product > Simulation product
Dose confirmation technology route
- Bioburden detection: 3 batches of products, 10 pieces each, calculate the batch average and the total average
- Dose selection: Determine the sterilization dose and the corresponding bioburden range by referring to Table 3
- Verification experiment:
- When SIP < 1, the verification dose needs to be calibrated according to formula (1)
- Dose fluctuation needs to be controlled within ±10% or 0.1kGy (whichever is greater)
Sterilization dose audit mechanism
| Audit results | Handling measures | Follow-up requirements |
|---|---|---|
| 1-2 positive | Add 10 pieces for re-test | Pass if cumulative positives ≤ 2 |
| 3-6 positives | Immediately increase the dose (according to Chapter 8) | Need to re-establish the sterilization dose |
| ＞6 positives | Stop using the original dose | Sterilization process must be re-established |
Background of technological evolution
This standard is an extension of GB 18280.2-2015. The main innovations are:
- The sample size of the verification dose experiment is fixed at 10 pieces (the original standard is 25 pieces)
- Newly added 17.5kGy-32.5kGy intermediate gradient dose
- Introduction of SIP dose reduction factor (see Appendix A)
Based on computer simulation verification, it is confirmed that this method maintains SAL Significantly improve operating efficiency while ensuring a 10^-6 level.
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