GB/T 19633.1-2015: Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems

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Scope

This part of GB/T 19633 specifies the materials, pre-formed sterile barrier systems, sterile barrier systems and expected to remain final before use.
Requirements and test methods for sterile packaging systems for sterilized medical devices.
This section applies to industries, medical institutions, and any situation where medical devices are sterilized after being installed in a sterile barrier system.
This section does not include all requirements for sterile barrier systems and packaging systems for aseptically manufactured medical devices. Affection for drug and device combination
However, other requirements may also be required.
This section does not describe the quality assurance system for all manufacturing stages.

Basic Data

Standard ID	GB/T 19633.1-2015 (GB/T19633.1-2015)
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	11.080.30
Word Count Estimation	25,250
Date of Issue	2015-12-10
Date of Implementation	2016-09-01
Older Standard (superseded by this standard)	GB/T 19633-2005
Quoted Standard	ISO 5636-5-2003
Adopted Standard	ISO 11607-1-2006, 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 the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and sterile packaging systems that are expected to maintain a final sterilized medical device prior to use. This standard applies to industrial, medical institutions and any medical devices into the sterile barrier system sterilization after the situation. This standard does not cover all requirements for sterile barrier systems and packaging systems for aseptic manufacturing of medical devices. Other combinations may be required for combinations of drugs and devices. This standard does not describe the quality assurance system for all manufacturing stages of control.