YY/T 1302.2-2015: Physical requirements and microbiological performance of ethylene oxide sterilization - Part 2: Microbiological aspects

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Scope

This part of YY/T 1302 specifies process definition, validation, process
effectiveness maintenance, etc. for the microbiological aspects of ethylene
oxide sterilization.
This part applies to the ethylene oxide sterilization process for medical devices
and other related products or materials, provides solutions to various
microbiological aspects in the development and validation of ethylene oxide
(EO) sterilization processes. This part also provides additional application
guidelines for medical device manufacturers that use the ISO 11135-1:2007 and
ISO/TS 11135-2:2008 standards, including those that 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 bioburden and sterilization process.

Basic Data

Standard ID	YY/T 1302.2-2015 (YY/T1302.2-2015)
Description (Translated English)	Physical requirements and microbiological performance of ethylene oxide sterilization - Part 2: Microbiological aspects
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C47
Classification of International Standard	11.080.01
Word Count Estimation	21,279
Date of Issue	2015-03-02
Date of Implementation	2016-01-01
Quoted Standard	GB/T 19974-2005; 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
Regulation (derived from)	The State Food and Drug Administration Announcement 2015 No. 8
Issuing agency(ies)	State Food and Drug Administration
Summary	This Standard specifies the procedure for defining ethylene oxide sterilization of microorganisms, confirmed the validity of the process and maintenance. This section applies to medical devices and other related products or ethylene oxide sterilization process materials for ethylene oxide (EO) sterilization process development and validation of the various aspects of microbial provide a solution. This section also for the introduction of ISO 11135-1-2007 and ISO/TS 11135-2-2008 standard medical device manufacturers (including the use of manufacturers outsource sterilization plant or outsourced sterilization operations) to provide additional application guidance. This section YY/T 1302 did not include the various factors that may cut the product of biological negative influential and sterilization process.