GB 18278-2000
Replaced
YY/T 1607-2018
Active
Industry standards-Medicine
YY/T 1607-2018 Radiation sterilization of medical device—Method of dose setting
YY/T 1607-2018 Radiation sterilization of medical device—Method of dose setting
Basic Information
Standard Code:
YY/T 1607-2018
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Public medical equipment
ICS Name:
Integrated disinfection and sterilization
Publish Date:
2018-06-26
Implement Date:
2019-07-01
Pages:
19 pages
Scope
This standard specifies an improved method for Methods 2A and 2B in GB 18280.2-2015, which can reduce the number of groups used to determine the minimum incremental dose, allowing this minimum dose to meet the expected sterility assurance level. This standard applies to products with low bioburden or low radiation resistance, and where it has been demonstrated that they are consistent with historical levels. It is not applicable to products whose bioburden has not been evaluated.
Development Information
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