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

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Scope

This Document specifies requirements and test methods for materials, preformed sterile barrier
systems, sterile barrier systems and packaging systems that are intended to maintain sterility of
terminally sterilized medical devices until the point of use.

Basic Data

Standard ID	GB/T 19633.1-2024 (GB/T19633.1-2024)
Description (Translated English)	Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C47
Classification of International Standard	11.080.01
Word Count Estimation	66,639
Date of Issue	2024-05-28
Date of Implementation	2025-12-01
Issuing agency(ies)	State Administration for Market Regulation, China National Standardization Administration