Standard Number: YY 0970-2023(YY0970-2023)
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
English:Sterilization of health care products-Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives-Requirements for characterization, development,validation and routine control of a sterilization process for medical device
Effective Date:2026-05-01
ICS:11.080.01
Standard Applicability:This document specifies the characteristics of liquid chemical sterilizing agents for the sterilization of single-use medical devices derived in whole or in part from animal materials, as well as the requirements for sterilization development, validation, process control and monitoring. This document applies to the risk control of bacterial and fungal contamination during liquid chemical sterilization. Risks associated with other microorganisms may be assessed using other methods. This document does not apply to: materials of human origin; confirmation of viral and transmissible spongiform encephalopathy (TSE) inactivation; confirmation of protozoan and parasite inactivation or elimination; treatment processes to reduce the bioburden during manufacturing; testing and evaluation of the suitability of sterilization processes for the use of medical devices; and development of residual levels of sterilants in medical devices.
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