YY/T 1551.2-2017Air filters for medical infusion and transfusion equipments - Part 2: Liquid bacterial retention test method (English PDF)

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.

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.

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 document. 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.

4 Test device