YY/T 0681.10-2011Test methods for sterile medical device package - Part 10: Test for microbial barrier ranking of porous package material (English PDF)

Foreword

YY/T 0681 "sterile medical device packaging test method", consists of the following components.

--- Part 1. accelerated aging test guidelines;

--- Part 2. sealing strength flexible barrier material;

--- Part 3. Unconstrained pressure within the package of anti-sabotage;

--- Part 4. Determination of staining solution penetrate breathable packaging seal leakage;

--- Part 5. coarse leak was detected internal pressure (bubble method);

--- Part 6. flexible packaging material and ink coating chemical resistance evaluation;

--- Part 7. flexible packaging material ink or coating adhesion tape evaluation;

--- Part 8. coating layer weight determination;

--- Part 9. constraint plate internal pressure bursting test method flexible seal;

--- Part 10. permeable microbial barrier packaging material grading tests. This section YY/T Part of 100,681.

YY/T 0681 to modify this part of the technical aspects of using ASTM F1608-00 "permeable microbial barrier packaging material grading test side Law (chamber method). " This section drafted in accordance with GB/T 1.1-2009 given rules.

Introduction

ASTM had 11 laboratories participated in the collaborative study laboratory. Repeat the test laboratories of six commercially available breathable material like Reduce the product to determine the log value (LRV). Under standard conditions specified in this test method to test materials were tested, the average fed back The values range from LRV 1.7 to LRV 4.3.

The results of the laboratory collaborative study showed that when comparing experimental data and materials to be cautious when a given level, especially for repeat sample When the number of tests carried out much. In addition, this test method used to develop packaging performance standards, the need for further cooperation among laboratories For research.

1 Scope

Test methods YY/T 0681 provisions of this Part for the determination of airborne bacteria permeable material for the packaging of sterile medical devices Penetrating. This test method is designed to be able to penetrate the bacterial spores in the test material conditions of the material tested, in order to facilitate the material Be graded.

This test method requires operation microorganism only by trained personnel to operate.

NOTE: This test method precision and bias of the information in Appendix B.

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.

Standard atmospheric conditions GB/T 10739 paper, paperboard and pulp sample processing and testing

3 Terms and Definitions

The following terms and definitions apply to this document.

4 Summary of Test Method