GB/T 19633-2005 in English

《GB/T 19633-2005最终灭菌医疗器械的包装》由TC200（全国消毒技术与设备标准化技术委员会）归口，主管部门为国家药品监督管理局
本标准规定了用于最终灭菌医疗器械包装(或是在工厂中生产，或是在医疗保健机构中生产)的一次性使用材料和可再次使用的容器的要求(见第6章)。本标准概述了最终灭菌医疗器械制造者对包装过程开发和确认的主要要求(见第7章)。成型和密封被认为是最关键的过程，但其他过程操作也能最终包装有影响，对此本文也有阐述。本标准为最通用的操作和技术提供了指南。本标准规定了评价无菌医疗器械包装性能的基本要求(见第7章)。其目的是为医疗器械设计者和制造者对包装在加工、运输和贮存过程中对器械部件保护的全性能的鉴定提供出试验和评价框架。本标准不包括在无菌状态下生产的产品的包装；在这些情况下，应有附加要求确保包装和包装过程不会形成产品污染源。本标准不包括抽样方案的确定或平行试验组的数量和时间。

Scope

1.1 This standard specifies the requirements for single-use materials and reusable containers used for terminally sterilized medical device packaging (either produced in a factory or in a healthcare facility) (see Clause 6). 1.2 This standard outlines the main requirements for the development and validation of packaging processes by manufacturers of terminally sterilized medical devices (see Chapter 7). Forming and sealing are considered the most critical processes, but other process operations can also have an impact on the final packaging, which are also addressed in this article. This standard provides guidance for the most common practices and techniques. 1.3 This standard specifies the basic requirements for evaluating the packaging performance of sterile medical devices (see Chapter 7). Its purpose is to provide a test and evaluation framework for medical device designers and manufacturers to identify the full performance of packaging for the protection of device components during processing, transportation and storage. 1.4 This standard does not cover the packaging of products produced under aseptic conditions; in these cases, there should be additional requirements to ensure that the packaging and packaging process do not form a source of product contamination. 1.5 This standard does not cover the determination of sampling plans or the number and timing of parallel test groups.