您当前所在的位置:
CEN ISO/TS 16775-2014
中文名称：用于终端灭菌医疗器械的包装 - Iso 11607-1和Iso 11607-2（Iso/Ts 16775:2014）应用指南
英文名称：Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014)
| 中国标准分类(CCS)： | C47 |
| 国际标准分类(ICS)： | 11.080 |
| 发布日期： | 2014/7/1 |
| 实施日期： | |
| 页数： | |
| 标准状态： | 作废 |
| 点击数： | 290 |
| 废止日期： | 2021/12/1 |
| 适用范围： | This document will provide guidance on the application of ISO 11607-1:2006, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems and ISO 11607-2:2006, Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing, and assembly processes. Possible options for compliance with the requirements of Parts 1 and 2 will be addressed as special concerns than may require attention due to regional or local conditions, practices or regulations. Additional guidance on important packaging issues will also be included (see attached outline). |
浙公网安备 33020902000221号
