GB 18278-2000
Replaced
YY/T 1302.2-2015
Active
Industry standards-Medicine
YY/T 1302.2-2015 Physical requirements and microbiological performance of ethylene oxide sterilization—Part 2:Microbiological aspects
YY/T 1302.2-2015 Physical requirements and microbiological performance of ethylene oxide sterilization—Part 2:Microbiological aspects
Basic Information
Standard Code:
YY/T 1302.2-2015
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:
20 pages
Scope
This part of YY/T 1302 specifies the process definition, validation, and maintenance of process effectiveness for the microbiological aspects of ethylene oxide sterilization.
This part applies to the ethylene oxide sterilization process of medical devices and other related products or materials, and provides solutions to various microbiological issues in the development and validation of the ethylene oxide (EO) sterilization process. This part also provides additional application guidelines for medical device manufacturers who adopt ISO 11135-1:2007 and ISO/TS 11135-2:2008 standards, including manufacturers who use outsourced sterilization plants or outsourced sterilization operations.
This part of YY/T 1302 does not include various factors that may affect the product's biological load and the sterilization process.
Development Information
Same series standard
Referenced Standards
GB/T 19974-2005 Sterilization of health care products—General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices
ISO 11135-1:2007
ISO/TS 11135-2:2008
ISO 11138-1:2006
ISO 11138-2:2006
ISO 11737-1:2006
ISO 11737-2:2009
ISO 14161:2009
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