本文件规定了液体化学杀菌剂的特性要求，以及液体化学杀菌剂对一次性医疗器械（包括全部或部分动物源性材料）杀菌的开发、验证、过程控制和监测要求。 本文件涵盖了液体化学灭菌过程中细菌和真菌污染风险的控制。可使用其他方法评估与其他微生物相关的风险（见注1）。 本文件不适用于人类来源的材料。 本文件不描述病毒和传染性海绵状脑病（TSE）制剂灭活的验证方法（见注2和注3）。 本文件不描述原生动物和寄生虫灭活或消除的验证方法。 本文件中所述的验证和常规控制要求仅适用于医疗器械的规定灭菌过程，该过程在制造过程之后进行，且未考虑其他生物负载减少步骤的致命影响（见注4）。 本文件未规定确定任何选定灭菌过程对医疗器械适用性影响的测试（见注5）。 本文件不包括医疗器械中残留杀菌剂的水平（见注6）。 资料性附录a中提供了液体化学杀菌剂的特性以及液体化学杀菌剂对一次性医疗器械（包括全部或部分动物源性材料）进行杀菌的开发、验证、过程控制和监测的指南。 注1:如ISO 22442所述，事先将风险管理原则应用于使用动物组织的医疗设备- 1是很重要的。ISO 18362提供了细胞保健产品加工过程中微生物风险控制的信息。 注2:传统上用于医疗器械中动物组织灭菌的液体化学灭菌剂可能无法有效灭活TSE病原体，如牛海绵状脑病（BSE）或羊瘙痒病。根据本文件进行的令人满意的验证不一定能证明这种类型的感染性病原体是灭活的。ISO 22442中描述了与动物材料的采购、收集和处理相关的风险控制- 2. 注3:ISO 22442-3中描述了病毒和TSE试剂的失活、消除或消除和失活验证。 注4:含有动物组织的医疗器械的制造过程通常包括接触化学制剂，这可以显著降低医疗器械的生物负荷。在制造过程之后，医疗器械将暴露于特定的灭菌过程中。 注5:此类测试是医疗器械设计和开发的关键部分。 注6:ISO 10993-17规定了建立杀菌剂残留允许限值的方法。 注7:质量管理体系标准（见ISO 13485）可用于控制所有制造阶段，包括灭菌过程。

This document specifies requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin. This document covers the control of risks arising from contamination with bacteria and fungi by application of a liquid chemical sterilization process. Risks associated with other microorganisms can be assessed using other methods (see NOTE 1). This document is not applicable to material of human origin. This document does not describe methods for the validation of the inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (see NOTE 2 and NOTE 3). This document does not describe methods for validation of the inactivation or elimination of protozoa and parasites. The requirements for validation and routine control described in this document are only applicable to the defined sterilization process of a medical device, which is performed after the manufacturing process, and do not take account of the lethal effects of other bioburden reduction steps (see NOTE 4). This document does not specify tests to establish the effects of any chosen sterilization process upon the fitness for use of the medical device (see NOTE 5). This document does not cover the level of residual sterilizing agent within medical devices (see NOTE 6). Guidance for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin is provided in informative Annex A. NOTE 1 The prior application of risk management principles to medical devices utilizing animal tissues, as described in ISO 22442-1 is important. ISO 18362 provides information on control of microbial risks during processing of cell-based health-care products. NOTE 2 Liquid chemical sterilizing agents traditionally employed to sterilize animal tissues in medical devices might not be effective in inactivating the causative agents of TSE such as bovine spongiform encephalopathy (BSE), or scrapie. Satisfactory validation in accordance with this document does not necessarily demonstrate inactivation of infective agents of this type. Risk controls related to sourcing, collection and handling of animal materials are described in ISO 22442-2. NOTE 3 The validation of the inactivation, elimination, or elimination and inactivation of viruses and TSE agents is described in ISO 22442-3. NOTE 4 Manufacturing processes for medical devices containing animal tissues frequently include exposure to chemical agents which can significantly reduce the bioburden on the medical device. Following the manufacturing process, a medical device is exposed to a specified sterilization process. NOTE 5 Such testing is a crucial part of the design and development of a medical device. NOTE 6 ISO 10993-17 specifies a method to establish allowable limits for residues of sterilizing agents. NOTE 7 Standards for quality management systems (see ISO 13485) can be used in the control of all stages of manufacture including the sterilization process.