National Documents

Overview

ICCBBA encourages national organizations to create their own guidance documents for the use of ISBT 128 in their countries. These documents can dictate standard policies where the ISBT 128 Standard allows national variation. An example of allowed national variation is the bar code text that appears on a product label.

The UK and the US have shared their documents for others to see. We welcome other countries to do the same.

Jump to the section of interest:

 

Canada

Canadian Guidelines for the Uniform Labeling of Blood and Blood Components Using ISBT 128

The document is available on each of the websites listed below:

French: http://www.hema-quebec.qc.ca/hopitaux/sang/notice-lignes-directrices.fr.html

English: http://www.transfusionmedicine.ca/resources/uniform-labelling

 

Danmark

Regler for benyttelse af ISBT 128 findes i Transfusionsmedicinske Standarder findes i appendiks 10. Liste over anvendte facility identification codes findes i appendiks 11.

http://tms-online.dk/Transfusionsmedicinske Standarder - PDF

 

FDA Guidance - Tissues

This guidance is relevant to ISBT 128 for tissues. In this document ISBT 128 is recognized as the more widely-used industry standard for labeling blood and blood components.

Guidance - PDF

 

United Kingdom

Guidelines for Blood Transfusion Services in the UK

The 'Red Book' aims to define guidelines for all materials produced by the United Kingdom Blood Transfusion Services for both therapeutic and diagnostic use.

Click here for more details.

 

United States Documents - Blood

IG-002 United States Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 v3.0.0 - PDF (3 MB)

This document provides guidance on labeling requirements in the United States for blood and blood components.

US Labels Required to be FDA Reviewed - PDF

The FDA document lists what labels must be reviewed by the FDA for FDA licensed facilities.

US Codabar to ISBT 128 Map - xls (503 kB)

US Codabar to ISBT 128 Map - Version Control Sheet - PDF

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The map documents the mapping between US Codabar codes and ISBT 128 codes. The file is no longer maintained; it was last updated in January 2007.

 

United States Documents - Cellular Therapy

IG-003 United States Consensus Guidance for the Uniform Labeling of Cellular Therapy Products Using ISBT 128 v1.3.0 - PDF (4 MB)

This document provides background information and label examples for using ISBT 128 in cellular therapy facilities in the US. It outlines where information may be placed on an affixed label in order to standardize the label within the US as much as possible.

 

United Stated Documents - Tissues

IG-028 AATB/ICCBBA Interim Guidance Document For Use of ISBT 128 by North America v1.2.0 - PDF

The purpose of this document is to provide guidance on the implementation of the ISBT 128 Standard for tissues to those facilities that are moving forward with the introduction of ISBT 128. Specifically it provides guidance on:

  • Donation identification numbering
  • Phased implementation of product coding
  • Expiration date
  • Label design
  • Software design

 

United States - Frequently Asked Questions

Click here to view the US specific FAQs.