Standard No.:	GB 18469-2012
English Name:	Quality requirements for whole blood and blood components
Chinese Name:	全血及成分血质量要求
Chinese Classification:	C05    Medical science
Professional Classification:	GB    National Standard
Issued by:	AQSIQ;SAC
Issued on:	2012-5-11
Implemented on:	2012-7-1
Status:	valid
Superseding:	GB 18469-2001 STANDARDs for whole blood and blood components quality
Language:	English
File Format:	PDF
Word Count:	6000 words
Price(USD):	150.00
Delivery:	via email in 1 business day

1. Scope



This standard specifies quality requirements for whole blood and blood components provided by general blood station and for clinical infusion.

This standard is applicable to whole blood and blood components provided by general blood station and for clinical infusion.



2. Normative References



The following referenced documents are indispensable for the application of this document. For dated references, only the editions cited apply. For undated references, the latest editions of the normative documents (including any amendments) apply.

GB 14232.1 Plastics Collapsible Containers for Human Blood and Blood Components - Part 1: Conventional Containers



3. Terms and Definitions



For the purposes of this document, the terms and definitions specified in GB 14232.1 and those listed below apply.

3.1

Preservative solution

The medicament mainly consisting of anticoagulant and glucose and for preventing blood coagulation and maintaining activities and physiological functions of various components in blood.

3.2

Blood product

Uniform product formed by the mixture of certain amounts of blood or blood compositions of the satisfactory blood donor and certain amounts of preservative solution.

3.3

Additive solution

Foreword
1. Scope
2. Normative References
3. Terms and Definitions
4 Requirements for Blood Safety Testing
5 Blood Quality Control Requirements