ISO/TS 19930:2017提供了关于确定作为基于风险的方法的一部分应考虑的方面的指南，该方法用于为最终灭菌、一次性使用的医疗保健产品选择无菌保证水平（SAL），该产品无法承受处理，以获得最大10？6的SAL。 此外，本文件还提供 a） 无菌保证的背景信息和无菌保证水平，以及 b） 关于能够实现最大SAL 10？6的策略指导。 ISO/TS 19930:2017描述了质量管理体系的要素，该体系用于为最终灭菌、一次性使用的医疗保健产品选择合适的SAL，该产品无法承受处理，以达到最大10？6的SAL。 注:国际标准对灭菌过程的开发、验证和常规控制不要求有完整的质量管理体系。 请注意控制保健产品生命周期所有阶段的质量管理体系标准（见ISO 13485）。 ISO/TS 19930:2017适用于通过物理和/或化学方法灭活微生物的灭菌过程。 ISO/TS 19930:2017不适用 -选择最大SAL大于10？6的保健产品，该产品能够承受加工，以实现最大SAL为10？6； -在要求最大SAL为10-6且不允许替代SAL的情况下； -在其管辖范围内的监管机构已接受最大SAL大于10？6（例如10？3）的情况下，用于规定用途的保健产品； -对使用过的或再加工过的保健产品进行消毒； -通过过滤对保健品进行灭菌。 ISO/TS 19930:2017没有描述评估微生物失活的详细程序。 ISO/TS 19930:2017未规定对海绵状脑病（如羊瘙痒病、牛海绵状脑病和克雅氏病）病原体灭活过程的开发、验证和常规控制的要求。对于可能被这些制剂污染的材料的处理，特定国家已经提出了具体的建议。 注:另见ISO 22442-1、ISO 22442-2和ISO 22442-3。 ISO/TS 19930:2017不取代或修改特定灭菌过程的已发布国际标准。ISO/TS 19930:2017既不建议对给定的保健产品使用SAL，也不确定将保健产品标记为“无菌”的最大SAL。 注:这些事项由监管机构负责，各国可能有所不同。

ISO/TS 19930:2017 provides guidance on identifying the aspects to be considered as part of a risk-based approach to selecting a sterility assurance level (SAL) for terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a SAL of 10 6. In addition, this document provides a) background information on the assurance of sterility and sterility assurance level, and b) guidance on strategies that can allow the achievement of a maximal SAL of 10 6. ISO/TS 19930:2017 describes the elements of a quality management system which are applied to enable the appropriate selection of a SAL for terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a SAL of 10 6. NOTE It is not a requirement of the International Standards for development, validation and routine control of a sterilization process to have a full quality management system. Attention is drawn to the standard for quality management systems (see ISO 13485) that controls all stages of the lifecycle of health care product. ISO/TS 19930:2017 is applicable to sterilization processes in which microorganisms are inactivated by physical and/or chemical means. ISO/TS 19930:2017 does not apply - to selecting a maximal SAL greater than 10 6 for health care product that is able to withstand processing to achieve maximally a SAL of 10 6; - in cases where a maximal SAL of 10 6 is required and an alternative SAL is not allowed; - in cases where a maximal SAL of greater than 10 6 (e.g. 10 3) has been accepted by regulatory authorities within their jurisdiction for health care product for defined use; - to the sterilization of used or reprocessed health care product; - to sterilization of health care product by filtration. ISO/TS 19930:2017 does not describe detailed procedures for assessing microbial inactivation. ISO/TS 19930:2017 does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. NOTE See also ISO 22442 1, ISO 22442 2 and ISO 22442 3. ISO/TS 19930:2017 does not supersede or modify published International Standards for particular sterilization processes. ISO/TS 19930:2017 neither recommends a SAL for a given health care product nor identifies a maximal SAL for a health care product to be labelled "sterile". NOTE These are matters for regulatory authorities and can vary from country to country.