YY/T 0929.1-2014Sterilizing-grade filters for medical infusion equipments - Part 1: Integrity test for fluid filters (English PDF)

Foreword

YY/T 0929 "infusion sterilizing grade filter" consists of the following components.

--- Part 1. liquid filter integrity test;

--- Part 2. Air filter integrity test. This section YY/T Section 10929 of.

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

Introduction

Clinically, patients receiving intravenous fluids at the time, due to environmental factors, operation, microorganisms may enter the infusion system, some infusions (Eg parenteral nutrition) contribute to the propagation of bacteria, once contaminated, often leads to transfusion complications. Installation of sterilizing grade filter infusion is One effective safety precautions.

Membrane of a nominal pore size of not more than 0.22µm liquid filter is now recognized as sterilizing grade liquid filter. Yet to see the current international Infusion liquid through the liquid sterilizing grade filter integrity test method standards. This reference document "American injections Association (PDA) Technical Report No.40" Evaluation is given liquid filter integrity test guidelines.

Quality membranes and membrane assembly quality in the housing determines the filter integrity. Bubble point pressure liquid filters are typically used to evaluate Pore size of the filter material, if a filter is able to withstand the whole bubble point pressure, and adopted the "bubble point pressure test", it indicates that the filter is not only Filtration membrane integrity (ie filter pore size) to meet the requirements, but also the integrity of the assembly to meet the requirements.

The same pore sizes, there may be different bubble point pressure. Sterilizing grade filter liquid bubble point pressure limits should YY/T 0918 Given bacterial retention test results establish relevance.

Infusion set with a test pressure of liquid sterilizing grade filter integrity test is exposed (such as bubble point pressure) is often higher than the infusion Pro Extreme pressure (200kPa) bed, the common practice is to make the whole filter designed to withstand the test bubble point pressure. If the filter compressive strength Can not withstand the test of the integrity of the required pressure, it can not confirm having integrity deemed to not meet the requirements for clinical use. Infusion sterilizing grade filter Part 1.

1 Scope

YY/T 0929 provisions of this part of the infusion set with a filter of nominal pore size of not more than 0.22µm liquid filter integrity test method.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.

YY/T 0918 liquid filtration membranes, liquid filter bacterial retention test method

3 Terms and Definitions

The following terms and definitions apply to this document.