GB 18278-2000
Replaced
YY/T 1268-2015
Replaced
Industry standards-Medicine
YY/T 1268-2015 Product adoption and process equivalence for ethylene oxide sterilization
YY/T 1268-2015 Product adoption and process equivalence for ethylene oxide sterilization
Basic Information
Standard Code:
YY/T 1268-2015
Standard Type:
Industry standards
Standard Status:
Replaced
is_force_gb:
no
CCS Name:
Public medical equipment
ICS Name:
Integrated disinfection and sterilization
Publish Date:
2015-03-02
Implement Date:
2016-01-01
Pages:
13 pages
Scope
This standard specifies the equivalence of the sterilization process when using different equipment for new products or products with changes in the original confirmed ethylene oxide sterilization process.
This standard applies to medical devices that are processed by the ethylene oxide (EO) sterilization method and adopt either the traditional release or the parameter-based release approach.
Development Information
Superseded by the following standards
Referenced Standards
Related Standards
GB 18281.1-2000
Replaced
GB 18281.1-2000 Sterilization of health care products—Biological indicators—Part 1:General
GB 18281.2-2000
Replaced
GB 18281.2-2000 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization
GB 18281.3-2000
Replaced
GB 18281.3-2000 Sterilization of health care products—Biological indicators—Part 3:Biological indicators for moist heat sterilization
GB 18282.1-2000
Replaced
GB 18282.1-2000 Sterilization of health care products—Chemical indicators—Part 1:General requirements
YY/T 0567.2-2005
Replaced