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YY/T 0918-2014

Chinese Standard: 'YY/T 0918-2014'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY/T 0918-2014English299 Add to Cart Days<=3 Test method for determining bacterial retention of membrane/ filter assembly utilized for infusion liquid filtration Valid YY/T 0918-2014
YY/T 0918-2014Chinese18 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]

   

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 & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C31
Classification of International Standard 11.040.20
Word Count Estimation 15,121
Date of Issue 2014/6/17
Date of Implementation 2015/7/1
Quoted Standard GB/T 6682; YY/T 0929.1
Drafting Organization Shandong Province Quality Inspection Center for Medical Devices
Administrative Organization National medical infusion appliances Standardization Technical Committee
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

YY/T 0918-2014
Test method for determining bacterial retention of membrane/filter assembly utilized for infusion liquid filtration
ICS 11.040.20
C31
People's Republic of China pharmaceutical industry standards
Liquid filtration membranes, liquid filter
Test methods for bacterial retention
Testmethodfordeterminingbacterialretentionofmembrane /
Issued on. 2014-06-17
2015-07-01 implementation
China Food and Drug Administration released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
The standard reference ASTMF838-05 "Standard Test Method for entrapping liquid filtration with a membrane filter bacteria" to develop.
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This standard by the National Standardization Technical Committee medical infusion apparatus.
This standard drafting units. Shandong Medical Devices Product Quality Inspection Center.
The Standard participating units. Pal Filter (Beijing) Co., Ltd. in Hangzhou Kono filtration equipment.
Drafters of this standard. Wu Ping, Wang Wenqing, and Tang, step by Zhang, Lin Weijian.
introduction
While the current infusion and the infusion have been terminally sterilized, but in some medical conditions are relatively poor environment, pharmaceuticals and connections
Infusion equipment will still process microorganisms in the environment may be introduced into the infusion system. Some infusion fluid (such as certain nutrient solution) itself has
Contribute to the growth of microorganisms. Thus, the liquid sterilizing grade filters have considerable market demand. The method given in this standard can be used to determine the sterilizing grade
Liquid filtration membrane filter in the liquid retention capacity of bacteria.
Currently accepted in the liquid membrane to filter out bacteria in the maximum pore size is 0.22μm. Typically, this test is only through the liquid filtration
Film before the membrane pore size is nominally 0.22μm.
Limitations of bacterial retention test in that it can not filter membrane liquid filter production process control routine. Conventional control
Generally use the bubble point pressure test test filtration membrane filter pore size and integrity (see YY/T 0929.1), the bubble point pressure indicators subject to this standard
Quasi given for confirmation.
Some aseptic processing medical device manufacturing process confirmation for sterilizing filter sterilization capability evaluation may also be given in this standard
method.
Liquid filtration membranes, liquid filter
Test methods for bacterial retention
1 Scope
Test methods specified in this standard applies to nominal pore size of not more than 0.22μm filter membrane or medical device with a liquid sterilizing grade liquid
Filter bacteria retention capacity was evaluated.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
Laboratory use specifications and test methods GB/T 6682 Analysis
YY/T 0929.1 infusion sterilizing filter Part 1. liquid filter integrity test
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
reducing the value of log logreductionvalue; LRV
The number of microbes challenge filtrate microorganism ratio of the number of values in base 10.
4 Summary of Test Method
With a certain volume and concentration of defects aeruginosa (ATCC19146) bacterial suspension to both sides of the film is not higher than 200kPa pressure difference and every level
Cc effective filtration area (EFA) 2mL/min ~ 4mL/min flow rate, tried to supply sterilized membrane filters or pick
War, so that the final challenge level is not less than 107CFU/cm2EFA. All filtrates were then analyzed after membrane filtration, the analysis filter means
Cultured in solid medium. You will be able to form a visible colony tried through the membrane or filter for bacteria on the analysis membrane, and into the
The row count.
NOTE. When you need to assess whether the filter or filter membrane to maintain its long-term use of bacterial retention capacity, we can use the test program is given in Appendix A.
5. Significance and Use
5.1 Test methods designed to evaluate the sterilizing grade filter membrane or filter bacteria retention capacity under clinical conditions.
5.2 per square centimeter of the effective filtration area is subjected to 107 bacterial challenge levels much higher than the sterile filtration process. The selection of challenges
It is to provide high level of security for the filter membrane filter or intercept a large amount of microorganisms.
6 Instruments
6.1 stainless steel pressure vessel.
6.2 air conditioner.
Related standard:   YY/T 0923-2014  YY/T 0926-2014
Related PDF sample:   YY/T 0927-2014  YY/T 0328-2015
   
 
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