YY/T 1286.2-2016 English PDF

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YY/T 1286.2-2016: Performance for platelets storage bag--Part 2: Test guide on evaluation for platelet storability
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1286.2-2016	179	Add to Cart	3 days	Performance for platelets storage bag--Part 2: Test guide on evaluation for platelet storability	Valid

Similar standards

YY/T 1293.5   YY/T 1291   YY/T 1288   YY/T 1293.2   YY/T 1282   YY/T 1286.1   

Basic data

Standard ID: YY/T 1286.2-2016 (YY/T1286.2-2016)
Description (Translated English): Performance for platelets storage bag--Part 2: Test guide on evaluation for platelet storability
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C31
Classification of International Standard: 11.040.20
Word Count Estimation: 9,942
Date of Issue: 2016-01-26
Date of Implementation: 2017-01-01
Quoted Standard: GB 14232.3; GB 18469
Regulation (derived from): China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies guidelines for the evaluation of platelet bag storage performance evaluation methods, including platelet hypotonic shock test, pH test, eddy current visual test and aggregation test.

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

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Performance for platelets storage bag - Part 2. Test guide on evaluation for platelet storability ICS 11.040.20 C31 People's Republic of China Pharmaceutical Industry Standard Platelet storage bag performance Part 2. Guidelines for evaluation of platelet storage performance Part 2. Testguideonevaluationforplateletstorability 2016-01-26 release 2017-01-01 Implementation State Food and Drug Administration issued

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. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This section is proposed by the State Food and Drug Administration. This part of the National Medical Pipeline Standardization Technical Committee (SAC/TC106) centralized. This part of the drafting unit. Institute of Blood Transfusion, Chinese Academy of Medical Sciences, Nanjing Sunway Biological Technology Co., Ltd., Shandong Province, medical equipment products Quality Inspection Center, Shanghai Blood Transfusion Technology Co., Ltd. This part of the main drafters. Liu Jiaxin, Wang Hong, Hu Zhengfang, Qiao Chunxia, Sun Xiaoxia, Jiang Yueqin.

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. Platelet storage bag performance Part 2. Guidelines for evaluation of platelet storage performance

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 article Pieces. 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

4.1 Sample preparation The use of specific specifications for the use of the platelet storage bags, in accordance with the actual use of platelets need to save the appropriate dose of fresh Prepared platelets. 4.2 Storage conditions During the test, platelets were stored at 20 ° C to 24 ° C, with an oscillation frequency of 60 times/min and an amplitude of 5 cm.

5 during the platelet evaluation project and time

Select the test item and time according to Table 1. Table 1 Platelet evaluation test items and time Storage time Platelet hypotonic shock test (Chapter 6) Eddy current test a (Chapter 7) pH test a (Chapter 8) Platelet aggregation test (Chapter 9) 1d after blood collection After blood collection 3d √ √ √ N.Ab

5 days after blood collection

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