GB/T 19633-2005 English Version, GB/T 19633-2005 Packaging for terminally sterilized medical devices (English Version)

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Position: Chinese Standard in English/GB/T 19633-2005

GB/T 19633-2005 Packaging for terminally sterilized medical devices (English Version)
Standard No.:	GB/T 19633-2005	Status:	superseded remind me the status change Email:
Target Language:	English	File Format:	PDF
Word Count:	8500 words	Translation Price(USD):	250.0 remind me the price change Email:
Implemented on:	2005-5-1	Delivery:	via email in 1~3 business day

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Standard No.:	GB/T 19633-2005
English Name:	Packaging for terminally sterilized medical devices
Chinese Name:	最终灭菌医疗器械的包装
Chinese Classification:	C30 Medical apparatus and devices in general
Professional Classification:	GB National Standard
Source Content Issued by:	AQSIQ;SAC
Issued on:	2005-1-24
Implemented on:	2005-5-1
Status:	superseded
Superseded by:	GB/T 19633.1~19633.2-2015 GB/T 19633.2-2015 Packaging for terminally sterilized medical devices―Part 2:Validation requirements for forming,sealing and assembly processes GB/T 19633.1-2015 Packaging for terminally sterilized medical devices―Part 1:Requirements for materials, sterile barrier systems and packaging systems
Superseded on:	2016-9-1
Target Language:	English
File Format:	PDF
Word Count:	8500 words
Translation Price(USD):	250.0
Delivery:	via email in 1~3 business day

GB/T 19633-2005 is referred in:

* YY 0502-2005 Knee joint prostheses
*YY 0861-2011 Ophthalmic optics—Ophthalmic viscosurgical devices
*YY/T 0681.1-2009 Test methods for sterile medical device package—Part 1:Test guide for accelerated aging
*YY/T 1553-2017 Cardiovascular implants-Cardiac occluder
*YY/T 0595-2006 Medical devices-Quality management systems-Guidance on the application of YY/T0287-2003
*WS 310.1-2016 Central sterile supply department(CSSD) Part 1:Management standard

Standard

GB/T 19633-2005 Packaging for terminally sterilized medical devices (English Version)
Standard No.	GB/T 19633-2005
Status	superseded
Language	English
File Format	PDF
Word Count	8500 words
Price(USD)	250.0
Implemented on	2005-5-1
Delivery	via email in 1~3 business day

Detail of GB/T 19633-2005

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Introduction of GB/T 19633-2005

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。

Contents of GB/T 19633-2005

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Keywords:
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