GB/T 19633.2-2024: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes

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Scope

This document specifies requirements for the development and validation of processes
for packaging medical devices that are terminally sterilized. These processes include
forming, sealing and assembly of preformed sterile barrier systems, sterile barrier
systems and packaging systems.

Basic Data

Standard ID	GB/T 19633.2-2024 (GB/T19633.2-2024)
Description (Translated English)	Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C47
Classification of International Standard	11.080.30
Word Count Estimation	22,267
Date of Issue	2024-05-28
Date of Implementation	2025-12-01
Issuing agency(ies)	State Administration for Market Regulation, China National Standardization Administration