
【国际标准】 Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization — Amendment 1: Selection of items for dose setting
本网站 发布时间:
2025-02-18
开通会员免费在线看70000余条国内标准,赠送文本下载次数,单本最低仅合13.3元!还可享标准出版进度查询、定制跟踪推送、标准查新等超多特权!  
查看详情>>

适用范围:
暂无
标准号:
ISO 11137:1995/Amd 1:2001 EN
标准名称:
Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization — Amendment 1: Selection of items for dose setting
英文名称:
Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization — Amendment 1: Selection of items for dose setting标准状态:
废止-
发布日期:
2001-12-13 -
实施日期:
出版语种:
EN
- 推荐标准
- ISO 15882:2008 EN 56c7f63a Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
- ISO 17664-1:2021 EN a71b1df6 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
- ISO 17665:2024 EN 55d5bf6c Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
- ISO 18362:2016 EN 13b08b18 Manufacture of cell-based health care products — Control of microbial risks during processing
- ISO 18362:2016/Amd 1:2022 EN 1310eba1 Manufacture of cell-based health care products — Control of microbial risks during processing — Amendment 1
- ISO 18472:2018 EN cfbc2bcf Sterilization of health care products — Biological and chemical indicators — Test equipment
- ISO 20857:2010 EN 463de8cc Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
- ISO 25424:2018 EN b936e481 Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
- ISO 11137-1:2006 EN 4707f3b5 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- ISO 11137-1:2006/Amd 1:2013 EN 6ca4c31b Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 1
- ISO 11137-2:2013 EN d6ba5ed4 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
- ISO 11138-2:2017 EN 6bebea16 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
- ISO 11138-7:2019 EN 2d355df9 Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results
- ISO 11138-8:2021 EN 35fa07aa Sterilization of health care products — Biological indicators — Part 8: Method for validation of a reduced incubation time for a biological indicator
- ISO 11139:2018 EN 78bdb3d9 Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards