Test method specified in this Standard applies to the evaluation of bacterial retention of sterilizing-grade membranes or filter assemblies utilized for infusion liquid filtration for medical devices with a nominal pore size not exceeding 0.22 μm.
Basic Data
Standard ID
YY/T 0918-2014 (YY/T0918-2014)
Description (Translated English)
Test method for determining bacterial retention of membrane/ filter assembly utilized for infusion liquid filtration
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C31
Classification of International Standard
11.040.20
Word Count Estimation
15,182
Date of Issue
6/17/2014
Date of Implementation
7/1/2015
Quoted Standard
GB/T 6682; YY/T 0929.1
Regulation (derived from)
China Food and Drug Administration in 2014 Bulletin No. 30
Issuing agency(ies)
State Food and Drug Administration
Summary
This Standard applies to nominal pore size of not more than 0. 22��m medical devices or liquid filtration membrane filter with a liquid bacterial sterilizing grade retention capacity evaluation. This Standard specifies the liquid filtration membrane, liqui
