GB/T 19633.2-2015: Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes

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Scope

GB/T 19633 provisions of this part of the development and validation requirements for terminally sterilized medical devices packaging process. These processes include
Preformed sterile barrier systems, sterile barrier systems and packaging systems forming, sealing and assembly.
This section applies to industrial, medical institutions, medical device packaging and sterilization.
This section does not include packaging requirements for sterile medical devices manufacturing. For the combination of drugs and devices, there may be other requirements.

Basic Data

Standard ID	GB/T 19633.2-2015 (GB/T19633.2-2015)
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	14,151
Date of Issue	2015-12-10
Date of Implementation	2016-09-01
Older Standard (superseded by this standard)	GB/T 19633-2005
Quoted Standard	GB/T 19633.1-2015
Adopted Standard	ISO 11607-2-2006, IDT
Regulation (derived from)	National Standard Announcement 2015 No.38
Issuing agency(ies)	General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary	This standard specifies requirements for the development and validation of the packaging process for terminally sterilized medical devices. These processes include preformed sterile barrier systems, sterile barrier systems and packaging systems forming, sealing and assembly. This standard applies to industrial, medical institutions, medical device packaging and sterilization. This standard does not include requirements for the packaging of sterile medical devices manufacturing. For the combination of drugs and devices, there may be other requirements.