GB/T 19633.1-2015 Active
GB/T 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems
Abstract
This part of GB/T 19633 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems, and packaging systems intended to maintain the sterility of medical devices that are expected to be sterilized before use.
This part is applicable to industries, medical institutions, and any situation where medical devices are sterilized after being packaged in sterile barrier systems.
This part does not include all the requirements for sterile barrier systems and packaging systems used in the sterile manufacturing of medical devices. For the case of drug-device combinations, other requirements may also be necessary.
This part does not describe the quality assurance system for controlling all manufacturing stages.
General Product Information
| Document Type | National standards |
|---|---|
| Standard Status | Active |
| Standard Code | GB/T 19633.1-2015 |
| CCS | Public medical equipment |
| ICS | Disinfection and packaging |
| Implement Date | 2016-09-01 |