GB 18278-2000
Replaced
GB/T 18280.2-2025
Pending
National standards
GB/T 18280.2-2025 Sterilization of health care products—Radiation—Part 2:Establishing the sterilization dose
GB/T 18280.2-2025 Sterilization of health care products—Radiation—Part 2:Establishing the sterilization dose
Price:
$ 155
Basic Information
Standard Code:
GB/T 18280.2-2025
Standard Type:
National standards
Standard Status:
Pending
is_force_gb:
no
CCS Name:
Public medical equipment
ICS Name:
Integrated disinfection and sterilization
Publish Date:
2025-12-02
Implement Date:
2027-07-01
Pages:
68 pages
Scope
This document specifies the method of setting the minimum dose required to meet specific sterility requirements and verifying that the sterilization dose of 15 kGy, 17.5 kGy, 20 kGy, 22.5 kGy, 25 kGy, 27.5 kGy, 30 kGy, 32.5 kGy, or 35 kGy can achieve a sterility assurance level (SAL) of 10-6, as well as the method of reviewing the sterilization dose to demonstrate its continuous effectiveness. This document defines the product families used for establishing and reviewing sterilization doses. This document applies to the establishment and maintenance of radiation sterilization doses for medical devices. Note: This document applies to medical devices, but the establishment and maintenance of radiation sterilization doses can also be used for other products.
Development Information
Same series standard
GB 18280.1-2025 Sterilization of health care products—Radiation—Part 1:Requirements for the development,validation and routine control of a sterilization process for medical devices
GB/T 18280.3-2025 Sterilization of health care products—Radiation—Part 3:Guidance on dosimetric aspects of development,validation and routine control
Replace the following standards
Referenced Standards
GB 18280.1-2015 Sterilization of health care products—Radiation—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
GB/T 19973.1-2005 Sterilization of medical devices—Microbiological methods—Part 1:Estimation of population of microorganisms on products
GB/T 19973.1-2015 Sterilization of medical devices—Microbiological methods—Part 1:Determination of a population of microorganisms on products
GB/T 19973.1-2023 Sterilization of health care products—Microbiological methods—Part 1:Determination of a population of microorganisms on products
GB/T 19973.2-2005 Sterilization of medical devices—Microbiological methods—Part 2:Tests of sterility performed in the validation of a sterilization process
GB/T 19973.2-2018 Sterilization of medical devices—Microbiological methods—Part 2:Tests of sterility performed in the definition,validation and maintenance of a sterilization process
GB/T 19973.2-2025 Sterilization of health care products—Microbiological methods—Part 2:Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 13004
GB 18280.1-2025 Sterilization of health care products—Radiation—Part 1:Requirements for the development,validation and routine control of a sterilization process for medical devices
Adopt standards
ISO 11137-2:2013
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