This part of YY/T 1302 specifies the physical requirements for the sterilization of ethylene oxide. This part is intended to provide guidance for sterilization equipment, preconditioning, calculation of relative humidity, concentration of ethylene oxide, flammability, statistical applications in process equivalents.
Basic Data
Standard ID
YY/T 1302.1-2015 (YY/T1302.1-2015)
Description (Translated English)
Physical requirements and microbiological performance of ethylene oxide sterilization - Part 1: Physical 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
19,181
Date of Issue
2015-03-02
Date of Implementation
2016-01-01
Quoted Standard
GB 3836.1-2010; GB 3836.14-2014; GB 50169-2006; GBZ 2.1-2007; ISO 11135-1-2007
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 requirements for ethylene oxide sterilization physics. This Standard applies to sterilization equipment, pretreatment, to calculate the relative humidity, concentration of ethylene oxide, a flammable and provide guidance in the application of statistical process equivalent.
