GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials,sterile barrier systems and packaging systems

Scope

This document specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems, and packaging systems that are expected to maintain the sterility of final sterilized medical devices before use.
This document does not include all the requirements for sterile barrier systems and packaging systems used in the sterile manufacturing of medical devices. In the case of drug-device combinations, additional requirements may also be necessary.
This document does not describe the quality assurance system for controlling all manufacturing stages.
This document does not apply to packaging materials and/or packaging systems during the transportation of contaminated medical devices to reprocessing or disposal sites.

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