GB 18278-2000
Replaced
GB 18280.2-2015
Active
National standards
force_standard
GB 18280.2-2015 Sterilization of health care products—Radiation—Part 2:Establishing the sterilization dose
GB 18280.2-2015 Sterilization of health care products—Radiation—Part 2:Establishing the sterilization dose
Basic Information
Standard Code:
GB 18280.2-2015
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
yes
CCS Name:
Public medical equipment
ICS Name:
Integrated disinfection and sterilization
Publish Date:
2015-12-31
Implement Date:
2017-07-01
Pages:
55 pages
Scope
This part of GB 18280 specifies the method of setting the minimum dose to meet the special requirements for sterility and the method of confirming that 25 kGy or 15 kGy is the sterilization dose that can achieve a sterility assurance level (SAL) of 10-6. This part also specifies the method of dose audit to prove that the sterilization dose is continuously effective.
This part defines the product family used for dose establishment and dose audit.
Development Information
Same series standard
Replace the following standards
Referenced Standards
Adopt standards
ISO 11137-2:2006
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