BS EN ISO 11737-2:2020规定了具有以下特征的医疗器械无菌检测的一般标准: 暴露于灭菌剂治疗的患者，其数量比预期常规使用的要少 灭菌处理。这些测试旨在定义、验证或维护 灭菌过程。交叉引用:ISO 10012ISO 11737-1ISO 13485ISO/IEC 17025ISO 11135-1ISO/TS 11135-2ISO 11137-1ISO 11137-2ISO 11138-2ISO/TS 11139ISO 14160ISO 14161ISO 14644- 1ISO 14644-4ISO 14644-7ISO 14937ISO 17665-1ISO 20857ISO 9000ISO 90001ISO 9000390/385/EEC93/42/EEC98/79/E购买本文件时提供的所有现行修订版均包含在购买本文件中。

BS EN ISO 11737-2:2020 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent 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.Cross References:ISO 10012ISO 11737-1ISO 13485ISO/IEC 17025ISO 11135-1ISO/TS 11135-2ISO 11137-1ISO 11137-2ISO 11138-2ISO/TS 11139ISO 14160ISO 14161ISO 14644-1ISO 14644-4ISO 14644-7ISO 14937ISO 17665-1ISO 20857ISO 9000ISO 9001ISO 9000390/385/EEC93/42/EEC98/79/ECAll current amendments available at time of purchase are included with the purchase of this document.