『衡坤检测』关于FDA对灭菌医疗器械的要求
当无菌医疗器械美国上市，制造商需要对灭菌的整个过程进行控制，并且FDA对灭菌方式进行了推荐，并且控制做出指南。
FDA对灭菌方式进行推荐
A. Established Sterilization Methods:
Examples of these Established Category A Sterilization Methods:
· EO with devices in a fixed, rigid chamber
· Moist heat or steam
· Radiation (e.g., gamma, electron beam)
以上灭菌方式具有长期安全和有效的使用历史，通过多种信息来源如大量的文献，510(k)s的许可或上市前批准(PMA)申请的批准，以及满意的QS检查证明了这一点。在开发、验证和常规控制方面都有FDA认可的自愿共识标准。
Examples of these Established Category B Sterilization Methods:
· Hydrogen peroxide (H2O2)
· Ozone (O3)
· Flexible bag systems (e.g., EO in a flexible bag system, diffusion method, injection method)
以上灭菌方式，虽然没有fda认可的专用共识标准，但是已经发布了关于开发、验证和常规控制的信息。
B. Novel Sterilization Methods:
Examples of Novel Sterilization Methods:
· Vaporized peracetic acid
· High intensity light or pulse light
· Microwave radiation
· Sound waves
· Ultraviolet light
这些新开发方法存在很少或根本没有发布信息,没有全面的食品及药物管理局评估灭菌的历史发展和验证数据通过FDA的510 (k)或批准PMA设备消毒的方法,也没有FDA-recognized专用的共识标准开发、验证和常规控制。一种新的灭菌方法是FDA尚未审查并确定足以有效灭菌设备用于其预期用途的方法。
灭菌方式对510(k)技术文档及标签的要求
1.灭菌方法的说明
2.灭菌室的描述（灭菌室验证）
3.如是Category B灭菌方式，需要采取获取K号的设备
4.辐照灭菌，需要对剂量进行控制
5.EO, H2O2 灭菌，需要对最大浓度进行控制
6.EO灭菌后，需要对释放进行测试采取标准AAMI/ANSI/ISO 10993-7, Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals.
FDA共识标准可在以下网站进行查询：
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
共识标准可参照如下（仅限常用灭菌方式）
ISO 11139 First edition 2018-08 Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards
ISO 11737-2 Third edition 2019-12 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ASTM ISO 52628 Second edition 2020-04 Standard practice for dosimetry in radiation processing
ANSI AAMI ISO 11135:2014
Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices.
ISO 11607-1 Second edition 2019-02 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2 Second edition 2019-02 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
AAMI/ANSI/ISO 10993-7, Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals.
ISO 11137-1 First edition 2006-04-15 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2018)]
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