YY/T 1551.1-2017 (YY/T1551.1-2017, YYT 1551.1-2017, YYT1551.1-2017)
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| YY/T 1551.1-2017 | English | 199 |
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Air filters for medical infusion and transfusion equipments—Part 1: Aerosol bacterial retention test method
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YY/T 1551.1-2017
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Standards related to: YY/T 1551.1-2017
| Standard ID | YY/T 1551.1-2017 (YY/T1551.1-2017) | | Description (Translated English) | Air filters for medical infusion and transfusion equipments--Part 1: Aerosol 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 | 10,134 | | 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. | | Administrative Organization | National Medical Infusion Equipment Standardization Technical Committee (SAC/TC 106) | | Issuing agency(ies) | State Food and Drug Administration | YY/T 1551.1-2017
Air filters for medical infusion and transfusion equipments-Part 1. Aerosol 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 1. Aerosol bacterial retention test method
Part 1.Aerosolbacterialretentiontestmethod
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 1.
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.
The main drafters of this section. Wu Ping, Wang Wenqing, Zhang Junwei, Guo Xian Hu, Shaodan Dan, Tang Yan.
introduction
Currently, there are several ways to evaluate the retention of gas filters, including liquid bacterial retention tests, aerosol bacterial retention tests, and
Aerosol virus retention test. Aerosol bacterial entrapment tests first aerosolize the bacterial suspension and then challenge the air filter
Test method. Aerosol bacterial retention tests are less stringent than liquid bacterial retention tests but do represent an air filter challenge
The true situation.
This part of the simulation by infusion, blood transfusion with air filters in clinical applications, the use of Staphylococcus aureus as a challenge bacteria
Strain and set the test parameters to ensure more stringent than the typical situation in clinical use, the establishment of a suitable infusion, blood transfusion apparatus with air filtration
Methods for evaluating bacterial entrapment ability. This test is infusion, blood transfusion device with a general air filter bacteria retention capacity requirements. In addition,
For air filters with a nominal pore size of 0.22 μm, liquid bacterial retention tests are required.
As aerosol bacterial entrapment test destructive test, the method is more complicated, and the test conditions and personnel operating requirements are high, generally not
Suitable for general quality control of air filters. Conventional quality control can be used to establish correlation with aerosol bacterial entrapment tests
Physical integrity test methods.
Infusion, blood transfusion device with air filter
Part 1. Aerosol bacterial retention test method
1 Scope
YY/T 1551 provisions of this part of the test method is suitable for transfusion, blood transfusion devices with air filter finished product bacterial retention
Evaluation.
Infusion, blood transfusion apparatus with air filtration membrane bacterial retention capacity evaluation can refer to this section.
This test should be conducted by trained test personnel in biosafety laboratories.
2 test system
2.1 Overview
Test device schematic diagram shown in Figure 1. The test set includes six routes, five of which are tested as samples and one as a positive control. Mainly by
Aerosol generator, aerosol chamber, sample challenge assembly, liquid impact sampler and suction system. Test setup, bacterial challenge suspension and
The collected liquid forms the aerosol bacterial entrapment test system.
Bacterial challenge suspensions at a particular concentration produce a bacterial aerosol via the aerosol generator and are sprayed into the aerosol chamber. Negative pressure suction system
The test air filter in the sample challenge assembly was subjected to the bacterial aerosol challenge at the prescribed flow rate. Impinge the sample with the liquid containing the collected liquid
The bacteria that passed through the sample were collected, and bacterial count analysis of the collected liquid was performed to evaluate aerosol bacterial entrapment of the test air filter
ability.
2.2 Aerosol generator
Aerosolized bacteria challenge suspensions produced aerosol particles with an average particle diameter (MPS) of about 3.0 [mu] m.
2.3 Aerosol Room
The aerosol chamber is a cube of the box, the side length of 280mm, the aerosol chamber should be designed to use transparent materials in order to facilitate observation of aerosols
Formation, should be resistant to disinfection. The aerosol chamber is equipped with a vent with an air filter for balancing the pressure in the chamber,
Evenly dispersed aerosol fan.
2.4 Sample Challenge Component
The sample challenge assembly is used to load the test air filter such that the test air filter extends from one side that contacts the intended use environment to the other side
Withstand the challenge. The recommended sample challenge component schematic is shown in Figure 2.
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