YY/T 1648-2019Methods of establishing correlation between bubble point pressure and bacterial retention ability of filters for medical infusion equipments (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

Introduction

The filtration performance test of the liquid filter and the air filter for the infusion device can be carried out by physical integrity test and bacterial retention test.

Ways. The characteristics of the former type of test are simple and time-consuming, but the test results can only indirectly reflect the filtration performance of the product.

The product process inspection project, the representative test is the bubble point pressure test and the water breakthrough method test; the latter type of test is characterized by direct reflection of the product Bacterial retention performance, but the method is complex, time-consuming, high cost, high requirements for inspection facilities and inspection personnel, suitable for type inspection projects, Representative test methods are liquid bacterial retention test and aerosol bacterial retention test.

It should be noted that this standard only provides a method for correlating the bubble point pressure with the bacteria retention capacity for the filter for infusion devices.

Filters for infusion sets are not required to establish a correlation between bubble point pressure and bacterial retention capacity when performing integrity testing, only when When using the bubble point test results as the daily control standard for the filter integrity project for infusion sets, the bubble point test results need to be followed.

This standard can only be used if it is associated with the results of the bacteria retention test. See Appendix A for further description of specific test operations.

1 Scope

This standard specifies the bubble point pressure and bacteria of the liquid filter (including the infusion circuit on the blood transfusion device) and the air filter. The method of establishing the ability to intercept.

This standard applies to correlating the bubble point pressure of a filter for an infusion set with the ability to retain bacteria.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this document. For undated references, the latest edition (including all amendments) applies to this document.

YY/T 0918 liquid filtration membrane, liquid filtration filter method for bacterial retention

YY/T 0929.1 Infusion filter for infusion - Part 1. Liquid filter integrity test

YY/T 0929.2 Liquid filter for infusions - Part 2. Capsules of Candida albicans with a nominal pore size of 1.2 µm method Air filters for infusion and blood transfusion devices - Part 1. Methods Air filters for infusion and blood transfusion devices - Part 2. Methods Air filters for infusion and blood transfusions - Part 3. Methods of completeness test

3 Terms and definitions

The following terms and definitions apply to this document.