YY 0970-2023
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 (English Version)
- Standard No.
- YY 0970-2023
- Language
- Chinese, Available in English version
- Release Date
- 2023
- Published By
- 国家药监局
- Latest
- YY 0970-2023
- Replace
- YY 0970-2013
- Scope
- This document specifies the characteristics of liquid chemical sterilants for the sterilization of single-use medical devices derived in whole or in part from animal material, and the requirements for sterilization development, validation, process control and monitoring. This document applies to the risk control of bacterial and fungal contamination during chemical sterilization of liquids. Risks associated with other microorganisms may be assessed using other methods. This document does not apply to: Materials of human origin; Confirmation of inactivation of viruses and transmissible spongiform encephalopathies (TSE); Confirmation of inactivation or elimination of protozoa and parasites; Processing processes to reduce bioburden during production; Sterilization Process testing and evaluation of suitability of medical devices for use; establishment of sterilant residue levels in medical devices.
YY 0970-2023 history
- 2023 YY 0970-2023 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
- 2013 YY 0970-2013 Sterilization of single-use medical devices incorporating materials of animal origin.Validation and routine control of sterilization by liquid sterilants
