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YY/T 0929.2-2018

Chinese Standard: 'YY/T 0929.2-2018'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY/T 0929.2-2018English139 Add to Cart Days<=3 Liquid filters for medical infusion equipments - Part 2: Test method for determining candida albicans retention of 1.2 μm filter Valid YY/T 0929.2-2018
YY/T 0929.2-2018Chinese16 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]  

   

BASIC DATA
Standard ID YY/T 0929.2-2018 (YY/T0929.2-2018)
Description (Translated English) Liquid filters for medical infusion equipments - Part 2: Test method for determining candida albicans retention of 1.2 ��m filter
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C31
Classification of International Standard 11.040.20
Word Count Estimation 8,827
Date of Issue 2018-12-20
Date of Implementation 2020-01-01
Drafting Organization Shandong Medical Device Product Quality Inspection Center
Administrative Organization National Medical Infusion Device Standardization Technical Committee
Regulation (derived from) State Drug Administration Announcement No. 97 of 2018
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration
Summary This standard specifies the Candida albicans interception test method for the nominal pore size 1.2��m liquid chemical filter. This standard is applicable to the evaluation of the microbial retention capacity of a liquid filter that claims to be able to filter Candida albicans with a nominal pore size of 1.2 ��m.

YY/T 0929.2-2018
(Liquid infusion filters for infusion - Part 2. Test method for withdrawal of Candida albicans with a nominal pore size of 1.2 μm)
ICS 11.040.20
C31
People's Republic of China Pharmaceutical Industry Standard
Infusion liquid filter
Part 2. Nominal pore size 1.2μm liquid filter
Candida albicans interception test method
Liquidfiltersformedicalinfusionequipments-Part 2.Testmethodfor
Published on.2018-12-20
2020-01-01 implementation
State Drug Administration issued
Foreword
YY/T 0929 "Liquid filter for infusion" is divided into two parts.
---Part 1. Decontamination filter integrity test method 1);
--- Part 2. Test method for the retention of Candida albicans with a nominal pore size of 1.2 μm.
This part is the second part of YY/T 0929.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This part is proposed by the State Drug Administration.
This part is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Devices (SAC/TC106).
This section drafted by. Shandong Province Medical Device Product Quality Inspection Center, Hangzhou Annuo Filtration Equipment Co., Ltd., Hangzhou Ke Baite
Filter Equipment Co., Ltd., Pall Filter (Beijing) Co., Ltd., Shandong Xinhua Ande Medical Products Co., Ltd.
The main drafters of this section. Guo Xianhu, Zhang Junwei, Jiang Shuping, Zhao Dan, Li Songhua, Qi Tongqing, Zhou Qing, Liu Hongyan, Wang Wenqing.
1) Corresponds to YY/T 0929.1-2014 "Inoculation filter for infusion Part 1. Test for integrity of liquid filter". The standard is revised next time
The standard name will be adjusted.
introduction
At present, the infusion set with the nominal pore size 1.2μm liquid filter is mainly used for the whole nutrient mixture containing fat milk, lansoprazole and other drugs.
Intravenous infusion of the substance. For fat emulsion drugs, the main function of the liquid filter is to filter out particles and bubbles. For Lansola
The main function of the azole drug, the liquid filter is to filter out the sediment which may be generated during the infusion process.
The whole nutrient mixture contains carbohydrates, amino acids, lipids, vitamins, minerals and trace elements, which is a good growth ring for microorganisms.
territory. Although care is taken to maintain sterility during production, formulation, and infusion, microbial contamination occasionally occurs. Among them, Candida
It is the most typical contaminating microorganism. It is generally believed that the nominal pore size 1.2μm liquid filter used for infusion of the whole nutrient mixture is filtered.
In addition to particles and bubbles, it can effectively filter out Candida which may be contaminated.
The latex particle suspension filtration rate test is given in YY 0286.1 as the pass filter performance of the nominal pore size 1.2μm liquid chemical filter.
Requirements; at the same time, it should be able to pass the Candida albicans strain for the nominal pore size 1.2μm liquid filter that claims to be able to filter out Candida albicans
Leave the test.
This part of YY/T 0929 gives a test method for the Candida albicans interception of a 1.2 μm nominal liquid pore filter. Because of this method
It is complicated and not suitable for routine inspection. For routine inspection, refer to the liquid filter integrity test specified in YY/T 0929.1, provided that
It is the prescribed bubble point depression limit that has been associated with the Candida albicans interception test.
Infusion liquid filter
Part 2. Nominal pore size 1.2μm liquid filter
Candida albicans interception test method
1 Scope
This part of YY/T 0929 specifies the Candida albicans interception test method for a nominal pore size 1.2 μm liquid chemical filter.
This section applies to the microbial retention capacity of a liquid filter that claims to be able to filter out Candida albicans with a nominal pore size of 1.2 μm.
Evaluation.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
Pharmacopoeia of the People's Republic of China (2015 edition four)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Total nutrient mixture totalnutrientadmixture; TNA
In the aseptic conditions, the nutrients such as carbohydrates, fat milk, amino acids, electrolytes, vitamins, trace elements and water required by the body
The injection solution is mixed in proportion.
4 Method Overview
Simulate clinical use conditions to enable the specified challenge level of Candida albicans challenge suspension to be supplied under specified challenge flow and challenge time
The test solution filter is challenged, and the filtrate is collected and subjected to microbiological analysis to evaluate the microbial retention capacity of the test solution filter.
5 Instruments and equipment
5.1 Peristaltic pump (or infusion pump) and associated pump tube.
5.2 Incubator.
5.3 Biological safety cabinet.
5.4 Pressure steam sterilizer.
5.5 Microbial filter device and matching filter bowl.
5.6 Phase contrast microscope.
6 reagents and materials
6.1 Whole nutrient mixture, commercially available or prepared by yourself, see 7.1.
Related standard:   YY/T 0929.1-2014  YY/T 0918-2014
Related PDF sample:   YY/T 0927-2014  YY/T 0282-2009
   
 
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