标准编号:ISO/TS 16775:2021
中文名称:终端灭菌医疗器械的包装 ISO 11607-1和ISO 11607-2的应用指南
英文名称:Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2
发布日期:2021-11
标准范围
This document provides guidance for the application of the requirements contained in ISO 11607-1 and ISO 11607-2. It does not add to, or otherwise change, the requirements of ISO 11607-1 and ISO 11607-2. This is an informative document, not normative. It does not include requirements to be used as basis of regulatory inspection or certification assessment activities.