YY 0970-2023 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

Scope

This document specifies the characteristics of liquid chemical disinfectants used for sterilizing single-use medical devices wholly or partially derived 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 the liquid chemical disinfection process. Risks related to other microorganisms can be evaluated using other methods (see Note 1).
This document does not apply to: — Materials derived from human sources; — Confirmation of virus and transmissible spongiform encephalopathy (TSE) inactivation (see Notes 2 and 3); — Confirmation of protozoa and parasites inactivation or elimination; — Processes for reducing biological load during production (see Note 4); — Testing and evaluation of the suitability of medical devices for sterilization processes (see Note 5); — Establishment of sterilant residual levels in medical devices (see Note 6).
Note 1: According to YY/T 0771.1, it is essential to prioritize the application of risk management principles for animal-derived medical devices. ISO 18362 provides microbiological risk control for the production process of cell-based healthcare products.
Note 2: Liquid chemical disinfectants are typically used for sterilizing animal tissues in medical devices, but may not be effective in inactivating pathogens of transmissible spongiform encephalopathy (TSE), such as bovine spongiform encephalopathy (BSE) or scrapie. Therefore, the methods described in this document should not be used to confirm the inactivation of such infectious agents. For risk control related to the source, collection, and disposal of animal materials, see YY/T 0771.2.
Note 3: Confirmation of the inactivation or/and elimination of viral and TSE pathogens is described in YY/T 0771.3.
Note 4: The production process of animal-derived medical devic

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