YY/T 1551.1-2017 Air filters for medical infusion and transfusion equipments - Part 1: Aerosol bacterial retention test method
1 Scope
The test method specified in this part of YY/T 1551 is applicable to evaluating the bacterial retention capacity of finished air filters for medical infusion and transfusion equipment.
This part may be referred to during evaluation of bacterial retention capacity of air filter membrane materials used in medical infusion and transfusion equipment.
This test should be conducted by trained testers in a biosafety laboratory.
2 Test system
2.1 General
The schematic diagram of the test apparatus is shown in Figure 1. The test apparatus consists of six branches, of which five are used for sample testing and one is used for positive control. It is mainly composed of an aerosol generator, an aerosol chamber, sample challenge assemblies, liquid impact samplers, and a suction system. The test apparatus, bacterial challenge suspension, collection fluid, etc., together constitute the aerosol bacterial retention test system.
The bacterial challenge suspension of a specific concentration is aerosolized by the aerosol generator, and then the resulting bacterial aerosol is sprayed into the aerosol chamber. The negative pressure suction system allows the air filter under test in the sample challenge assembly to be challenged with the bacterial aerosol at a specified flow rate. The bacteria penetrating the sample are then collected using a liquid impact sampler filled with collection fluid, and the collection fluid is analyzed for bacterial counts to evaluate the aerosol bacterial retention capacity of the air filter under test.
2.2 Aerosol generator
The aerosol generator aerosolizes the bacterial challenge suspension to produce aerosol particles with a mean particle size (MPS) of approximately 3.0μm.
2.3 Aerosol chamber
The aerosol chamber is a cubic box with a side length of 280mm. It should be made of transparent materials to facilitate observation of aerosol formation, and it shall also be able to withstand disinfection treatment. The aerosol chamber shall be designed with an air vent fitted with an air filter for balancing the pressure in the chamber and a fan for uniformly dispersing the aerosol.
2.4 Sample challenge assembly
Foreword I
Introduction II
1 Scope
2 Test system
3 Reagents and materials
4 Preparation of bacterial challenge suspension
5 System verification
6 Challenge test
7 Result determination
8 Report
Bibliography
Standard
YY/T 1551.1-2017 Air filters for medical infusion and transfusion equipments-Part1:Aerosol bacterial retention test method (English Version)
Standard No.
YY/T 1551.1-2017
Status
valid
Language
English
File Format
PDF
Word Count
5500 words
Price(USD)
160.0
Implemented on
2018-1-1
Delivery
via email in 1 business day
Detail of YY/T 1551.1-2017
Standard No.
YY/T 1551.1-2017
English Name
Air filters for medical infusion and transfusion equipments-Part1:Aerosol bacterial retention test method
YY/T 1551.1-2017 Air filters for medical infusion and transfusion equipments - Part 1: Aerosol bacterial retention test method
1 Scope
The test method specified in this part of YY/T 1551 is applicable to evaluating the bacterial retention capacity of finished air filters for medical infusion and transfusion equipment.
This part may be referred to during evaluation of bacterial retention capacity of air filter membrane materials used in medical infusion and transfusion equipment.
This test should be conducted by trained testers in a biosafety laboratory.
2 Test system
2.1 General
The schematic diagram of the test apparatus is shown in Figure 1. The test apparatus consists of six branches, of which five are used for sample testing and one is used for positive control. It is mainly composed of an aerosol generator, an aerosol chamber, sample challenge assemblies, liquid impact samplers, and a suction system. The test apparatus, bacterial challenge suspension, collection fluid, etc., together constitute the aerosol bacterial retention test system.
The bacterial challenge suspension of a specific concentration is aerosolized by the aerosol generator, and then the resulting bacterial aerosol is sprayed into the aerosol chamber. The negative pressure suction system allows the air filter under test in the sample challenge assembly to be challenged with the bacterial aerosol at a specified flow rate. The bacteria penetrating the sample are then collected using a liquid impact sampler filled with collection fluid, and the collection fluid is analyzed for bacterial counts to evaluate the aerosol bacterial retention capacity of the air filter under test.
2.2 Aerosol generator
The aerosol generator aerosolizes the bacterial challenge suspension to produce aerosol particles with a mean particle size (MPS) of approximately 3.0μm.
2.3 Aerosol chamber
The aerosol chamber is a cubic box with a side length of 280mm. It should be made of transparent materials to facilitate observation of aerosol formation, and it shall also be able to withstand disinfection treatment. The aerosol chamber shall be designed with an air vent fitted with an air filter for balancing the pressure in the chamber and a fan for uniformly dispersing the aerosol.
2.4 Sample challenge assembly
Contents of YY/T 1551.1-2017
Foreword I
Introduction II
1 Scope
2 Test system
3 Reagents and materials
4 Preparation of bacterial challenge suspension
5 System verification
6 Challenge test
7 Result determination
8 Report
Bibliography
