GB/T 19633.2-2015
Packaging for terminally sterilized medical devices.Part 2:Validation requirements for forming, sealing and assembly processes (English Version)
- Standard No.
- GB/T 19633.2-2015
- Language
- Chinese, Available in English version
- Release Date
- 2015
- Published By
- General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
- Latest
- GB/T 19633.2-2015
- Replace
- GB/T 19633-2005
- Scope
- This part of GB/T 19633 specifies the requirements for the development and validation of the packaging process for terminally sterilized medical devices. These processes include forming, sealing and assembling of preformed sterile barrier systems, sterile barrier systems and packaging systems. This part applies to the packaging and sterilization of medical devices in industries and medical institutions. This section does not cover packaging requirements for medical devices manufactured aseptically. For drug and device combinations, there may be additional requirements.
GB/T 19633.2-2015 Referenced Document
- GB/T 19633.1-2015 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems*， 2016-09-01 Update
GB/T 19633.2-2015 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
