GB 18279.1-2015
Sterilization of health care products—Ethylene oxide—Part 1: Requirements for development,validation and routine control of a sterilization process for medical devices
医疗保健产品灭菌 环氧乙烷 第1部分：医疗器械灭菌过程的开发、确认和常规控制的要求
Explanation
GB 18279.1-2015 is a current mandatory Chinese national standard for Sterilization of health care products—Ethylene oxide—Part 1: Requirements for development,validation and routine control of a sterilization process for medical devices. It appears in the Food compliance cluster with a product safety focus and has an implementation date of Jan 1, 2017.
Applicability depends on product scope, certification route, competent authority notices and transition rules. Verify against the official source before using this record in a compliance decision.
Applicability hints
- Type
- Management
- CCS
- C47
- ICS
- 11.080.01
- Competent department
- National Medical Products Administration
- Technical committee
- National Technical Committee on Disinfection Technology and Equipment of Standardization Administration of China
Relationships
Partially replaces:GB 18279-2000
Replaced by:GB 18279-2023 (Upcoming)
Adopts ISO ISO 11135-1:2007 at Identical level.