YY 0970-2023 in English
VALIDSterilization of healthcare products Liquid chemical sterilants for single-use medical devices of animal origin Characterization, development, validation and routine control requirements for medical device sterilization processes
- Issued on:2023-03-14
- Implemented on:2026-05-01
- File Format:PDF
- Delivery:Via email within 6 business days
$630.00
| Standard No: | YY 0970-2023 |
| Document status: | VALID |
| Title in English: | Sterilization of healthcare products Liquid chemical sterilants for single-use medical devices of animal origin Characterization, development, validation and routine control requirements for medical device sterilization processes |
| Title in Chinese: | 医疗保健产品灭菌 一次性使用动物源性医疗器械的液体化学灭菌剂 医疗器械灭菌过程的特征、开发、确认和常规控制的要求 |
| Language: | English |
| File Format: | Electronic (PDF) |
| Delivery: | Via email within 6 business days |
| Issued on: | 2023-03-14 |
| Implemented on: | 2026-05-01 |
| ICS Classification: | 11.080.01-Sterilization and disinfection in general |
| Chinese Classification: | C47-Public medical equipment |
| Professional Classification: | YY-Pharmaceutics |
| Related Keywords: | medical device sterilization
sterilization validation single-use medical devices sterilization batch all/partial animal-derived disposable medical devices definition |
Introduction
Analysis of the core content of the standard
| Technical elements | Requirements of the 2013 version | New additions/changes in the 2023 version |
|---|---|---|
| Scope of the standard | Limited to devices containing animal-derived materials | Extended to all/partial animal-derived disposable medical devices |
| Definition of terms | 15 terms | 11 new key terms (such as holding time, parameter release, etc.) |
| Sterilization confirmation | 5 chapters of basic requirements | Newly added Chapters 5-6 Sterilant Characteristics, and Chapters 7-8 Product/Process Definition |
Key Technical Requirements
1. Sterilant Characteristics Specifications
Chapter 5 of the standard specifies that the following characteristics must be verified for liquid chemical sterilants:
- Microbial Killing Spectrum: The killing effect on standard strains such as Bacillus atrophaeus needs to be verified (see Table B.1)
- Material Compatibility: Evaluate the physical/chemical effects of sterilants on devices such as biological heart valves
- Environmental Safety: Material Safety Data Sheet (SDS) is required
2. Inactivation Dynamics Verification
Chapter 8 stipulates that the D value must be determined through an inactivation curve (at least 5 data points):
Example: In the sterilization validation of a tissue patch, the formula t≥D×(6+log10(100+B)) is used to calculate the holding time, where B is the bioburden value (determined according to GB/T 19973.1)
Implementation Recommendations
Key Points for Change Management
- Changes in the source of raw materials require re-evaluation of bioburden characteristics
- IQ/OQ/PQ reconfirmation must be performed after the sterilization equipment is modified
- Changes in the packaging system require verification of the penetration effect of the sterilant
Bioburden Control
Clause 7.4 of the standard requires the establishment of three levels of monitoring:
| Monitoring stage | Testing frequency | Action limit |
|---|---|---|
| Raw material receipt | Each batch | ≤100 CFU/g |
| After the key process | Weekly | Baseline value+2σ |
| Before sterilization | Each sterilization batch | ≤1000 CFU/piece |
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