WS 628-2018 in English
VALIDTechnical requirements for sanitary safety evaluation of disinfection products
- Issued on:2018-09-21
- Implemented on:2019-03-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
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本标准规定了消毒产品卫生安全评价的基本要求及内容。
本标准适用于中华人民共和国境内生产、经营和使用的除新消毒产品以外的第一类、第二类消毒产品（消毒剂、消毒器械、指示物、抗（抑）菌制剂）的卫生安全评价。
本标准不适用于定制消毒器械的卫生安全评价。
Introduction
Analysis of the core content of the standard
| Product category | Evaluation focus | Key test items |
|---|---|---|
| Class I disinfection products | Medical device sterilization/high-level disinfection | Spore killing test, toxicology test |
| Class II disinfection products | Conventional disinfection and antibacterial test | Microbial killing/inhibition test |
Background of technological evolution
This standard replaces the original scattered hygiene specifications and establishes a unified disinfection product evaluation system for the first time:
- 2005: Special specification for drinking water disinfectants
- 2018: Integration of full-scenario requirements such as medical devices and environmental object surfaces
- Innovation: Clarify the verification requirements for PCD devices, and refine the special testing procedures for commonly used disinfectants such as ethanol
Explanation of key terms
3.1 Hygiene and safety evaluation
Typical case: Before a endoscopic disinfectant is put on the market, it must complete the following:
1) Formula authenticity verification
2) Bacillus subtilis killing test (≥5.00 log)
3) Cytotoxicity test
3.3 Definition of Class I products
Including but not limited to:
->Hydrogen Peroxide Sterilizer Matching Solution
- Ethylene Oxide for Implant Sterilization
Implementation Recommendations
- Enterprise Standard Filing: To be disclosed on the National Enterprise Standard Information Public Service Platform
- Change Management: Formula changes require retesting of active ingredient content and key microbial indicators
- Report Timeliness: Test data for Category I products must be updated every 4 years (Appendix B Items)
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