GB 18278-2000
Replaced
YY/T 1403-2017
Active
Industry standards-Medicine
YY/T 1403-2017 Requirements of contract sterilization using ethylene oxide
YY/T 1403-2017 Requirements of contract sterilization using ethylene oxide
Basic Information
Standard Code:
YY/T 1403-2017
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Public medical equipment
ICS Name:
Integrated disinfection and sterilization
Publish Date:
2017-03-28
Implement Date:
2018-04-01
Pages:
12 pages
Scope
This standard specifies the requirements for outsourced sterilization with ethylene oxide, aiming to provide guidance for medical device manufacturers who adopt outsourced sterilization with ethylene oxide in accordance with GB 18279.1. For other guidance information, please refer to GB/T 18279.2.
This standard does not include the requirements for outsourced sterilization with ethylene oxide by healthcare institutions.
Development Information
Referenced Standards
YY/T 1302.2-2015 Physical requirements and microbiological performance of ethylene oxide sterilization—Part 2:Microbiological aspects
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
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