GB 18278-2000
Replaced
YY/T 1267-2015
Active
Industry standards-Medicine
YY/T 1267-2015 Evaluation of materials of medical device subject to ethylene oxide sterilization
YY/T 1267-2015 Evaluation of materials of medical device subject to ethylene oxide sterilization
Basic Information
Standard Code:
YY/T 1267-2015
Standard Type:
Industry standards
Standard Status:
Active
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:
12 pages
Scope
This standard specifies the selection of materials, design and processing, and material testing. It provides evaluation guidelines for assessing the adaptability of materials to ethylene oxide sterilization.
This standard applies to the evaluation of materials used in medical devices that are sterilized with ethylene oxide.
Development Information
Referenced Standards
YY/T 0884-2013 Evaluation of materials of health care product subject to radiation sterilization
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB 18279-2000 Medical devices—Validation and routine control of ethylene oxide sterilization
GB 18279-2023 Sterilization of health-care products—Ethylene oxide—Requirements for the development,validation and routine control of a sterilization process for medical devices
GB 18279.1-2015 Sterilization of health care products—Ethylene oxide—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
GB/T 18279.2-2015 Sterilization of health care products—Part 2:Guidance on the application of GB 18279.1
YY 0503-2005 Ethylene oxide sterilizer
YY 0503-2016 Ethylene oxide sterilizer
YY 0503-2023 Ethylene oxide sterilizer
YY/T 0822-2011 Ethylene oxide liquefied gas for sterilization
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