一次性医疗器械的灭菌 包含动物产地的材料 - 液体化学杀菌剂的灭菌验证和常规控制

[中文适用范围]： 本文件规定了液体化学灭菌剂特性的要求，以及全部或部分包含动物源材料的一次性医疗器械的液体化学灭菌剂灭菌的开发、验证、过程控制和监测的要求。 本文件涵盖了通过应用液体化学灭菌工艺来控制细菌和真菌污染所产生的风险。 与其他微生物相关的风险可以使用其他方法进行评估（见注 1）。 本文件不适用于人类来源的材料。 本文件没有描述病毒和传染性海绵状脑病（TSE）制剂灭活的验证方法（参见注释 2 和注释 3）。 本文件没有描述验证原生动物和寄生虫灭活或消除的方法。 本文件中描述的验证和常规控制要求仅适用于医疗器械定义的灭菌过程，该过程在制造过程之后进行，并且不考虑其他生物负载减少步骤的致命影响（见注4） ）。 本文件没有指定测试来确定任何选定的灭菌过程对医疗器械适用性的影响（见注释 5）。 本文件不涵盖医疗器械内残留灭菌剂的水平（见注释 6）。 液体化学灭菌剂的表征以及全部或部分包含动物源材料的一次性医疗器械的液体化学灭菌剂灭菌的开发、验证、过程控制和监测指南以信息性形式提供。 附件 A. 注 1：如 ISO 22442-1 中所述，对利用动物组织的医疗器械事先应用风险管理原则非常重要。 ISO 18362 提供了有关细胞保健产品加工过程中微生物风险控制的信息。 注 2：传统上用于对医疗器械中的动物组织进行灭菌的液体化学灭菌剂可能无法有效灭活 TSE 的病原体，例如牛海绵状脑病 (BSE) 或瘙痒病。 根据本文件的令人满意的验证并不一定证明这种类型的感染剂已失活。 ISO 22442-2 中描述了与动物材料的采购、收集和处理相关的风险控制。 注 3：ISO 22442-3 中描述了病毒和 TSE 因子的灭活、消除或消除和灭活的验证。 注 4：含有动物组织的医疗器械的制造过程经常包括接触化学制剂，这可以显着减少医疗器械上的生物负荷。 制造过程结束后，医疗器械将接受指定的灭菌过程。 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 规定了建立灭菌剂残留允许限值的方法。 注 7：质量管理体系标准（参见 ISO 13485）可用于控制生产的所有阶段，包括灭菌过程。 [外文原描述]： 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.