YY 0970-2023Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Characterization of a sterilization process for medical devices (English PDF)

YY 0970-2023 is the English-translated version of 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.

YY 0970-2023 is the Chinese standard "Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Characterization of a sterilization process for medical devices".

Its scope clause reads: This document specifies the requirements for liquid chemical sterilants for the sterilization of single-use medical devices wholly or partly derived from animal materials: characteristics, and requirements for sterilization development, validation, process control and monitoring: This document is applicable to the risk control of bacterial and fungal contamination in the liquid chemical sterilization process, the risks associated with other microorganisms can be used Other methods for evaluation (see Note 1): This document does not apply to: ---Materials of human origin; ---Confirmation of virus and transmissible spongiform encephalopathy (TSE) inactivation (see Note 2 and Note 3); --- Confirmation of inactivation or elimination of protozoa and parasites; --- Treatment process to reduce bioburden during production (see Note 4); --- Test and evaluation of the suitability of the sterilization process for the use of medical devices (see Note 5); ---Development of sterilant residue levels in medical devices (see Note 6): Note 1: According to the description in YY/T 0771:1, it is very important to prioritize the application of risk management principles for medical devices of animal origin: ISO 18362 provides the basis for Microbial risk control in the production process of cell-based healthcare products: NOTE 2: Liquid chemical sterilants are commonly used to sterilize animal tissues in medical devices and may be effective against transmissible spongiform encephalopathy (TSE) such as bovine spongiform encephalopathy (BSE) or inactivation of the causative agent of scrapie did not work: It is therefore not appropriate to use the methods of this document to confirm the inactivation of this class of infectious agents: and See YY/T 0771:2 for risk control related to the source, collection and disposal of animal materials: Note 3: See YY/T 0771:3 for confirmation of inactivation and/or elimination of viruses and TSE pathogenic factors: Note 4: The production process of medical devices of animal origin often includes exposure to chemical agents, which can significantly reduce the bioburden of medical devices: in the production process Afterwards, the medical device is exposed to a specific sterilization process: Note 5 to entry: Such tests are a key component in the design and development of medical devices: Note 6: GB/T 16886:17 specifies the method for establishing acceptable limits of sterilant residues:.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 32 pages — is available in the English PDF.

YY/T 0802.1|YY 1277|YY/T 1268|YY/T 0679

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