1.1本文件规定了暴露于灭菌剂处理的医疗器械无菌检测的一般标准，与常规灭菌处理中预期使用的灭菌剂相比，该灭菌剂已减少。在定义、验证或维护灭菌过程时，应进行这些试验。1.2本文件不适用于:a） 对经过灭菌过程的产品进行常规释放的无菌检测，b） 进行无菌检查（见3.12），注1 a）或b）的性能不是ISO 11135、ISO 11137-1、ISO 11137-2、ISO 14160、ISO 14937、ISO 17665-1或ISO 20857的要求。c） 无菌试验或无菌试验，用于证明产品的保质期、稳定性和\/或包装完整性，以及d） 生物指示剂或接种产品的培养。注2:ISO 11138-7中包含了培养生物指示剂的指南。

1.1 This document specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent which has been reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process. 1.2 This document is not applicable to: a) sterility testing for routine release of product that has been subjected to a sterilization process, b) performing a test for sterility (see 3.12), NOTE 1 The performance of a) or b) is not a requirement of ISO 11135, ISO 11137-1, ISO 11137-2, ISO 14160, ISO 14937, ISO 17665-1 or ISO 20857. c) test of sterility or test for sterility for demonstration of product shelf life, stability and/or package integrity, and d) culturing of biological indicators or inoculated products. NOTE 2 Guidance on culturing biological indicators is included in ISO 11138-7.