GB/T 19633.2-2015 Active National standards

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

Publish Date: 2015-12-10 Implement Date: 2016-09-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 19633.2-2015

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Public medical equipment

ICS Name: Disinfection and packaging

Publish Date: 2015-12-10

Implement Date: 2016-09-01

Pages: 13 pages

Scope

This part of GB/T 19633 specifies the requirements for the development and validation of the packaging process for terminally sterilized medical devices. These processes include the pre-formed sterile barrier systems, the formation, sealing, and assembly of sterile barrier systems and packaging systems.
This part is applicable to the packaging and sterilization of medical devices in industries and medical institutions.
This part does not include the packaging requirements for sterile manufacturing of medical devices. For combinations of drugs and devices, there may be other requirements as well.

Development Information

Word Count: 22 Thousand words Pages: 13 pages

Same series standard

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

Replace the following standards

GB/T 19633-2005 Packaging for terminally sterilized medical devices

Superseded by the following standards

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

Referenced Standards

ISO 11607-1

Adopt standards

ISO 11607-2:2006

Related Standards

YY/T 0681.3-2010 Active

YY/T 0681.3-2010 Test methods for sterile medical device package—Part 3:Internal pressurization failure resistance of unrestrained packages

Publish Date: 2010-12-27

YY/T 0681.4-2010 Replaced

YY/T 0681.4-2010 Test methods for sterile medical device package—Part 4:Detecting seal leaks in porous packages by dye penetration

Publish Date: 2010-12-27

YY/T 0681.10-2011 Active

YY/T 0681.10-2011 Test methods for sterile medical device package—Part 10:Test for microbial barrier ranking of porous package material

Publish Date: 2011-12-31

GB/T 19633.1-2015 Active

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

Publish Date: 2015-12-10

YY/T 0681.14-2018 Active

YY/T 0681.14-2018 Test methods for sterile medical device package—Part 14:Testing the microbial barrier for porous packaging materials under moist conditions and with passage of air

Publish Date: 2018-11-07

YY/T 0681.4-2021 Active

YY/T 0681.4-2021 Test methods for sterile medical device package—Part 4:Detecting seal leaks in porous packages by dye penetration

Publish Date: 2021-03-09