GB/T 19633-2005
Packaging for terminally sterilized medical devices (English Version)
- Standard No.
- GB/T 19633-2005
- Language
- Chinese, Available in English version
- Release Date
- 2005
- Published By
- General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
- Status
- 2016-09
- Replace By
- GB/T 19633.1-2015
- GB/T 19633.2-2015
- Latest
- GB/T 19633.1-2015
- GB/T 19633.2-2015
- 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.
GB/T 19633-2005 history
- 2016 GB/T 19633.1-2015 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- 2005 GB/T 19633-2005 Packaging for terminally sterilized medical devices
