ISO/TS 16775:2021 终端灭菌医疗器械的包装 ISO 11607-1和ISO 11607-2的应用指南

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

本文件为ISO？11607-1和ISO？11607-2中要求的应用提供了指南。它不会增加或改变ISO？11607-1和ISO？11607-2的要求。这是一份信息性文件，不是规范性文件。它不包括用作监管检查或认证评估活动基础的要求。本指南可用于更好地理解ISO？11607-1和ISO？11607-2的要求，并说明了可用于满足这些国际标准要求的各种方法和方法。无需使用本文件证明其符合要求。为包装材料、预制无菌屏障系统、无菌屏障系统和包装系统的评估、选择和使用提供指导。还提供了成型、密封和组装过程的验证要求指南。本文件为医疗机构和医疗器械行业提供最终灭菌医疗器械的信息。本文件不提供包装材料和系统开放后的应用指南。在将包装用于其他目的，如“无菌区”或运输受污染物品时，将适用其他监管标准。

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.The guidance can be used to better understand the requirements of ISO 11607-1 and ISO 11607-2 and illustrates the variety of methods and approaches available for meeting the requirements of those International Standards. It is not required that this document be used to demonstrate conformity with them.Guidance is given for evaluation, selection and use of packaging materials, preformed sterile barrier systems, sterile barrier systems and packaging systems. Guidance on validation requirements for forming, sealing and assembly processes is also given.This document provides information for both healthcare facilities and the medical devices industry for terminally sterilized medical devices.This document does not provide guidance for applications of packaging materials and systems after their opening. In the use of packaging for other purposes such as a “sterile field” or transport of contaminated items, other regulatory standards will apply.

标准预览图