ISO 11737-2:2019 医疗器械的灭菌 微生物学方法 第2部分：定义、确认和保持灭菌过程的无菌试验

标准编号：ISO 11737-2:2019

中文名称：医疗器械的灭菌 微生物学方法 第2部分：定义、确认和保持灭菌过程的无菌试验

英文名称：Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

发布日期：2019-12

标准范围

1.1本文件规定了对暴露于灭菌剂处理的医疗器械进行无菌试验的一般标准，该灭菌剂相对于常规灭菌过程中预期使用的灭菌剂已经减少。这些试验旨在定义、确认或维护灭菌工艺时进行。1.2本文件不适用于:a)对已进行灭菌过程的产品进行常规放行的无菌测试，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，以证明产品保质期、稳定性和/或包装完整性，以及d)生物指示剂或接种产物的培养。注2:关于培养生物指示剂的指南包含在ISO 11138-7中。

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, andd) culturing of biological indicators or inoculated products.NOTE 2 Guidance on culturing biological indicators is included in ISO 11138-7.

标准预览图