GB 18278-2000
Replaced
YY/T 1265-2015
Active
Industry standards-Medicine
YY/T 1265-2015 Evaluation of materials of medical device subject to moist heat sterilization
YY/T 1265-2015 Evaluation of materials of medical device subject to moist heat sterilization
Basic Information
Standard Code:
YY/T 1265-2015
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:
13 pages
Scope
This standard specifies the selection of materials, design and processing, and material testing. It provides evaluation guidelines for assessing the suitability of materials for wet heat sterilization.
This standard is applicable to the evaluation of materials used in medical devices subjected to wet heat sterilization.
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
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