GB/T 8600-1988
Replaced
YY/T 0681.18-2020
Active
Industry standards-Medicine
YY/T 0681.18-2020 Test methods for sterile medical device package—Part 18:Nondestructive detection of leaks in packages by vacuum decay method
YY/T 0681.18-2020 Test methods for sterile medical device package—Part 18:Nondestructive detection of leaks in packages by vacuum decay method
Basic Information
Standard Code:
YY/T 0681.18-2020
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Generally, it refers to microsurgical instruments
ICS Name:
Disinfection and sterilization
Publish Date:
2020-03-31
Implement Date:
2021-04-01
Pages:
22 pages
Scope
This part of YY/T 0681 specifies the test method for non-destructive testing of leakage in sterile medical device packaging systems using the vacuum attenuation method.
This part is applicable to hard and semi-hard trays without lids, trays or cups with breathable barrier lids, non-breathable hard packaging, and non-breathable soft packaging.
Development Information
Referenced Standards
GB/T 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems
GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials,sterile barrier systems and packaging systems
Related Standards
GB 8599-1988
Replaced
GB 8599-1988 Specifications for automated autoclave sterilizer
GB 15981-1995
Replaced
GB 15981-1995 Evaluating method and standard for the efficacy of disinfection and sterilization
GB 15982-1995
Replaced
GB 15982-1995 Hygienic standard for disinfection in hospitals
GB 16383-1996
Replaced
GB 16383-1996 Quality control standards for radiation sterilization of medical and hygienical products
GB 18279-2000
Replaced