YY/T 1551.2-2017 (YY/T1551.2-2017, YYT 1551.2-2017, YYT1551.2-2017) & related versions
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Air filters for medical infusion and transfusion equipments—Part 2: Liquid bacterial retention test method
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YY/T 1551.2-2017
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YYT 1551.2-2017
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YY/T 1551.2-2017: PDF in English (YYT 1551.2-2017)
YY/T 1551.2-2017
Air filters for medical infusion and transfusion equipments-Part 2. Liquid bacterial retention test method
ICS 11.040.20
C31
People's Republic of China pharmaceutical industry standards
Infusion, blood transfusion device with air filter
Part 2. Liquid bacterial retention test method
Part 2.Liquidbacterialretentiontestmethod
2017-02-28 Posted
2018-01-01 implementation
State Food and Drug Administration released
Foreword
YY/T 1551 "infusion, blood transfusion device with air filter" consists of the following components.
--- Part 1. Aerosol bacterial retention test method;
--- Part 2. Liquid bacterial retention test method;
--- Part 3. Integrity test methods;
This section is YY/T 1551 Part 2.
This section drafted in accordance with GB/T 1.1-2009 given rules.
Please note that some of this document may be patentable. The issuing agencies of this document do not bear the responsibility of identifying these patents.
This part of the National Medical Infusion utensils Standardization Technical Committee (SAC/TC106) centralized.
This section mainly drafted unit. Shandong Province Medical Device Quality Inspection Center, Hangzhou Annuo Filter Equipment Co., Ltd., Hangzhou Branch 100
Special Filter Equipment Co., Ltd., Pall Filter (Beijing) Co., Ltd., Shandong Zhongbokang Medical Appliance Co., Ltd., Shandong Xinhua Andean Medical
Supplies Co., Ltd.
The main drafters of this section. Wang Wenqing, Zhang Junwei, Jiang Shuping, Tang Yan, Yuan Xiaojing, Lu Zhihao, Li Songhua, Cheng Lin.
introduction
At present, there are several ways to evaluate the retention capacity of gas filters, including liquid bacterial entrapment test, aerosol bacterial entrapment test
As well as aerosol virus retention test. Liquid bacterial retention test is to use a low surface tension of liquid hydrophobic filter on the pre-run
Wet, and then refer to the bacterial liquid sterilizing liquid filter/membrane retention test method, with a diameter of 0.3μm ~ 0.4μm, length 0.6μm ~
1.0 < RTI ID = 0.0> um < / RTI> of B. subfamily (ATCC 19146). Correspondingly, reference to liquid sterilization filter, the current majority
The manufacturer will meet the liquid bacteria retention test requirements of the air filter nominal 0.22μm.
Due to the different filtering mechanism, the liquid accuracy of the filter is lower than the accuracy of the gas, and experiments have proved that the aerosol can be intercepted by the challenge
Cell/virus filters do not retain bacteriophage/virus in liquid challenge. It can be said that the liquid bacteria challenge test can represent gas
Filter the worst conditions sterilization.
Due to liquid bacteria retention test destructive test, the method is more complicated, and the test conditions and personnel requirements, generally not suitable
For general quality control of air filters. Conventional quality control can use substances that have established a correlation with liquid bacterial retention tests
Integrity test method.
Infusion, blood transfusion device with air filter
Part 2. Liquid bacterial retention test method
1 Scope
YY/T 1551 test method specified in this section applies to the nominal membrane pore size of 0.22μm infusion, blood transfusion appliances
Bacterial bacterial retention capacity of the finished product was evaluated.
Nominal filter pore size of 0.22μm infusion, transfusion apparatus with air filtration membrane bacterial retention capacity can refer to this section.
This test should be conducted by trained test personnel in biosafety laboratories.
2 Normative references
The following documents for the application of this document is essential. 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.
YY/T 0918-2014 liquid filtration membrane, liquid filter bacterial retention test method
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
log reduction value logreductionvalue; LRV
Challenges Base-10 logarithm of the ratio of the number of microorganisms to the number of microorganisms in the filtrate.
[YY/T 0918-2014, Definition 3.1]
4 test device
4.1 Overview
Test device schematic diagram shown in Figure 1 and Figure 2. When the test air filter from the side of contact with the expected use of the environment to pick the other side
In wartime, the test setup shown in Figure 1 can be used; when the challenge is reversed, the test setup shown in Figure 2 can be used. Defects under specified constant pressure
The B. aeruginosa ATCC 19146 bacterial suspension challenges the test air filter in the sample challenge assembly so that the ultimate challenge level is not low
Effective filter area (EFA) at 107 CFU/cm2 air filter. Bacterial count analysis of the filtrate to calculate the log reduction value
(LRV), in order to evaluate the test air filter.
4.2 pressure system
The pressure system is used to provide a constant challenge pressure, consisting of air pumps, pressure tanks and pressure gauges.
4.3 Sample Challenge Component
Sample Challenge Kit is used to load the test air filter and store the bacteria challenge suspension. When the test air filter is expected from the contact
This challenge component is required to challenge one side of the environment to the other. Should pay attention to the amount of bacterial challenge suspension to ensure that the entire challenge test
......
| Standard ID | YY/T 1551.2-2017 (YY/T1551.2-2017) | | Description (Translated English) | Air filters for medical infusion and transfusion equipments--Part 2: Liquid bacterial retention test method | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.20 | | Word Count Estimation | 8,839 | | Date of Issue | 2017-02-28 | | Date of Implementation | 2018-01-01 | | Drafting Organization | Shandong Province Medical Device Quality Inspection Center, Hangzhou Annuo Filter Equipment Co., Ltd., Hangzhou Branch Baxter Filter Equipment Co., Ltd., Pall Filter (Beijing) Co., Ltd., Shandong Zhongbokang Medical Appliance Co., Ltd., Shandong Xinhua Andean Medical Supplies Co., Ltd. | | Administrative Organization | National Medical Infusion Equipment Standardization Technical Committee (SAC/TC 106) | | Regulation (derived from) | China Food & Drug Administration Announcement 2017 No. 25 | | Issuing agency(ies) | State Food and Drug Administration |
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