YY/T 0681.3-2010 Active Industry standards-Medicine

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 Implement Date: 2012-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0681.3-2010

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Generally, it refers to microsurgical instruments

ICS Name: Disinfection and packaging

Publish Date: 2010-12-27

Implement Date: 2012-06-01

Pages: 9 pages

Scope

This part of YY/T 0681 specifies the procedures for determining the internal pressure resistance of packaging.
The bursting test involves gradually increasing the pressure inside the packaging until it is damaged.
The creep test involves applying a specified pressure and maintaining it for a specified period of time, or until the packaging is damaged.
Note: Appendix A provides information on the precision and bias of the test methods specified in this standard.

Development Information

Word Count: 15 Thousand words Pages: 9 pages

Same series standard

YY/T 0681.2-2010 Test methods for sterile medical device package—Part 2:Seal strength of flexible battier materials YY/T 0681.4-2010 Test methods for sterile medical device package—Part 4:Detecting seal leaks in porous packages by dye penetration YY/T 0681.5-2010 Test methods for sterile medical device package—Part 5:Detecting gross leaks in medical packaging by internal pressurization(bubble test)

Referenced Standards

GB/T 2918-1998 Plastics—Standard atmospheres for conditioning and testing GB/T 2918-2018 Plastics—Standard atmospheres for conditioning and testing YY/T 0681.2-2010 Test methods for sterile medical device package—Part 2:Seal strength of flexible battier materials

Adopt standards

ASTM F 1140-2007

Related Standards

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

GB/T 19633.2-2015 Active

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

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