GB 18278-2000
Replaced
YY/T 0567.7-2016
Active
Industry standards-Medicine
YY/T 0567.7-2016 Aseptic processing of health care products—Part 7:Alternative processes for medical devices and combination products
YY/T 0567.7-2016 Aseptic processing of health care products—Part 7:Alternative processes for medical devices and combination products
Basic Information
Standard Code:
YY/T 0567.7-2016
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Public medical equipment
ICS Name:
Integrated disinfection and sterilization
Publish Date:
2016-07-29
Implement Date:
2017-06-01
Pages:
21 pages
Scope
This standard specifies the requirements and provides guidance for the simulation production alternative method for confirming the sterile processing performance of medical devices and combination products that cannot be subjected to final sterilization and are not suitable for the simulation production method specified in YY/T 0567.1-2013.
This standard applies to the use of risk assessment to design simulation production studies for medical devices and combination products during the development of sterile processing, when it is not allowed to directly use culture media substitutes in the processing or when culture media cannot substitute for actual sterile processing.
Development Information
Referenced Standards
Adopt standards
ISO 13408-7:2012
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