CHN/1650
WTO/TBT
Chine - 11 - Technologies de la santé
- 90 - Instruments et appareils d'optique, de photographie ou de cinématographie, de mesure, de contrôle ou de précision; instruments et appareils médico-chirurgicaux; parties et accessoires de ces instruments ou appareils
2022-02-19
2021-12-22
Medical Devices; (HS: 902110); (ICS: 11.080.01)
National Standard of the P.R.C., Sterilization of Health-Care Products — Ethylene Oxide - Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices (66 page(s), in Chinese)
This document specifies requirements for the development, validation and routine control of the ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.
This document applies to the ethylene oxide sterilization process during the production of medical devices.