GB/T 19633.1-2015
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (English Version)
- Standard No.
- GB/T 19633.1-2015
- Language
- Chinese, Available in English version
- Release Date
- 2016
- Published By
- General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
- Latest
- GB/T 19633.1-2015
- Replace
- GB/T 19633-2005
- Scope
- This part of GB/T 19633 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile screen systems and packaging systems intended to maintain the sterility of terminally sterilized medical devices until use. This section is applicable to industry, medical institutions and any situation where medical devices are sterilized after they are packed and sterile barrier systems. This standard does not include all requirements for sterile barrier systems and packaging systems for aseptically manufactured medical devices. In the case of combinations of drugs and devices, additional requirements may be required. This section does not describe a quality assurance system that controls all stages of manufacture.
GB/T 19633.1-2015 Referenced Document
- ISO 5636-5:2003 Paper and board - Determination of air permeance and air resistance (medium range) - Part 5: Gurley method
GB/T 19633.1-2015 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
