ISO/TS 19930:2017 最大承受处理达到最大10^−6无菌、保证水平面的晚期的基于风险的方法来保证无菌消毒、一次性医疗产品指导

标准编号：ISO/TS 19930:2017

中文名称：最大承受处理达到最大10⁻⁶无菌、保证水平面的晚期的基于风险的方法来保证无菌消毒、一次性医疗产品指导

英文名称：Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assu

发布日期：2017-12

标准范围

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 providesa) background information on the assurance of sterility and sterility assurance level, andb) 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.

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