YY/T 1551.1-2017Air filters for medical infusion and transfusion equipments - Part 1: Aerosol bacterial retention test method (English PDF)
输液、输血器具用空气过滤器 第1部分：气溶胶细菌截留试验方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
February 28, 2017
Implementation date
January 1, 2018
Scope
YY/T 1551.1-2017 is the English-translated version of 输液、输血器具用空气过滤器 第1部分：气溶胶细菌截留试验方法.
YY/T 1551.1-2017 is the Chinese pharmaceutical industry standard that gives the method for evaluating the bacterial retention of the air filter of a finished infusion or transfusion set.
It is the first part of the YY/T 1551 series and sets out the challenge organism and its aerosol, the flow through the filter, the collection and counting of the organisms that pass and the calculation of the retention.
The filter membrane on its own may be evaluated by reference to the same method. Issued on 28 February 2017, it has applied since 1 January 2018.
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Document preview — YY/T 1551.1-2017
National Standard of the People's Republic of China
- ICS
- 11.040.20
- Classification
- C 31
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- Introduction
- 1 Scope
- 2 Test system
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.
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.
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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
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Related Standards
YY/T 1551.2-2017 — Air filters for medical infusion and transfusion equipments - Part 2: Liquid bacterial retention test method
YY/T 1551.3-2017 — Air filters for medical infusion and transfusion equipments - Part 3: Integrity test methods
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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YY/T 1551.1-2017
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