要求了评定医疗设备以及构成原材料造成影响的可能的程序流程。
有关ISO 10993-12:2021和ISO 10993-23:2021这两个规范,可点一下👇连接掌握相关内容:
新政策法规| ISO 10993规范升版危害
保健医疗商品杀菌
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1. EN ISO 11737-1:2018/A1:2021
Sterilization of health care products. Microbiological methods.Determination of a population of microorganisms onproducts(保健医疗商品杀菌.分子生物学方式.商品上微生物菌种种群的测量),相当于ISO11737-1:2018,要求了保健医疗商品、构件、原料或外包装内或表层活的生物种群的记数或分子生物学表现的规定,并带来了具体指导。
2. EN ISO 14160:2021
Sterilization of health care products- Liquid chemicalsterilizing agents for single-use medical devices utilizing animaltissues and their derivatives - Requirements for characterization,development, validation and routine control of
a sterilization process for medicaldevice(保健医疗商品的杀菌-应用动物组织以及化合物的一次应用的医疗设备常用的液态有机化学杀菌实验试剂-医疗器械注册杀菌流程的表现、开发设计、确定、及其日常操纵),相当于ISO14160:2020。
3. EN ISO 11135:2014/A1:2019
Sterilization of health-care products - Ethylene oxide -Requirements for the development, validation and routine control ofa sterilization process for medical devices - Amendment 1: Revisionof Annex E, Single batchrelease(环氧乙烷灭菌全过程的开发设计、确定、及其日常操纵,调整1:升级附则E),相当于ISO 11135:2014/Amd1:2018。
4. EN ISO 11137-1:2015/A2:2019
Sterilization of health care products - Radiation - Part 1:Requirements for development, validation and routine control of asterilization process for medical devices - Amendment 2: Revisionto 4.3.4 and 11.2 (辐照灭菌全过程的开发设计、确定和日常操纵),相当于ISO 11137-1:2006/Amd2:2018。
5. EN ISO 11737-2:2020
Sterilization of health care products - Microbiological methods- Part 2: Tests of sterility performed in the definition,validation and maintenance of a sterilizationprocess(在界定、确定和维护保养杀菌流程中完成的应用微生物菌种法的无菌检测检测),相当于ISO11737-2:2019。
6. EN ISO 25424:2019
Sterilization of health care products - Low temperature steamand formaldehyde - Requirements for development, validation androutine control of a sterilization process for medical devices(超低温蒸气和室内甲醛杀菌流程的开发设计、确定和日常操纵)
相当于ISO 25424:2018。
保健医疗商品无菌检测解决