ISO 11737-2:2019标准主要包括以下内容:
1.术语和定义:该部分介绍了与无菌测试相关的术语和定义,以确保标准的一致性和准确性。
2.测试方法:该部分介绍了无菌测试的方法和步骤,包括样品采集、培养基制备、接种、培养和观察等。该部分还介绍了不同类型的无菌测试方法,如直接接种法、膜过滤法和最概然数法等。
3.测试结果的解释:该部分介绍了无菌测试结果的解释和判断标准,以确定产品是否达到无菌状态。该部分还介绍了无菌测试结果的统计学分析方法,以确保测试结果的可靠性和准确性。
4.测试的验证和维护:该部分介绍了无菌测试的验证和维护方法,以确保测试的可靠性和准确性。该部分还介绍了无菌测试的频率和方法,以确保产品在整个灭菌过程中保持无菌状态。
总之,ISO 11737-2:2019标准是医疗保健产品灭菌过程中必不可少的标准之一,它确保了产品在灭菌过程中达到无菌状态,以保证产品的安全性和有效性。
相关标准
- ISO 11137-1:2006 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
- ISO 14937:2009 Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
- ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
- ISO 11138-3:2017 Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes