YY/T 1286.2-2016Performance for platelets storage bag - Part 2: Test guide on evaluation for platelet storability (English PDF)

Foreword

YY/T 1286 "platelet storage bag performance" is divided into two parts.

- Part 1. Determination of breathability of membrane materials - Differential pressure method; Part 2. Guidelines for evaluation of platelet storage performance. This part is part 2 of YY/T 1286.

This part is drafted in accordance with the rules given in GB/T 1.1-2009.

Introduction

The performance of platelet storage bags directly affects platelet storage quality and shelf life. Factors affecting platelet storage performance are very good In addition to storage temperature, oscillation conditions and platelet storage bags of materials, specifications, platelet storage performance is also affected by the number of platelets, volume, Deformation force and other factors.

At present, there is no uniform test method for evaluating the storage performance of platelet bags at home and abroad. This part is stored through platelets The efficacy of the platelets in the preservation of platelets was evaluated by the performance of the platelet storage bag, including the hypotonic shock response of the platelets, the pH, the visual eddy current (swirling) and aggregation reactions. It should also be noted that there are many tests for platelet function evaluation, given only in this section Guidance on test methods recommended in GB 14232.3. Platelet storage evaluation test also glucose concentration, lactic acid concentration and P election (CD62p) expression detection.

1 Scope

This section gives guidelines for the evaluation of platelet bag storage performance, including the platelet hypotonic shock test, the pH test, the vortex Test and aggregation test.

2 Normative reference documents

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

GB 14232.3 Human blood and blood ingredients - Plastic containers - Part 3. Blood bag systems with special components

GB 18469 Whole blood and ingredients Blood quality requirements

3 Terms and definitions

The terms and definitions defined in GB 14232.3 and GB 18469 apply to this document.

4 Sample preparation and storage

5 During the platelet evaluation project and time

Select the test item and time according to Table 1.