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

This document is available in French and English on each of the websites listed below:

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

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 1 MB


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.

Document - PDF

United Kingdom

Guidelines for Blood Transfusion Services in the UK

This link provides the online version of the UK Red Book.

United States Documents- Blood

US Consensus Standard for Blood

This document, the United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128, provides specific instructions for the US where there is flexibility in the ISBT 128 Standard Technical Specification.

File Size - 2MB

US Consensus Standard Errata Page

This document lists errors found in the US Consensus Standard Version 2.

US Consensus Standard for Blood Version 2.0.0 Version Control

This document lists the differences between Version 1 and 2 of the US Consensus Standard.

US Consensus Standard Version 3.0.0 DRAFT

The US Consensus v3.0.0 Draft Z is available to the public. The US Consensus for blood has been resubmitted to the FDA for their review on January 23, 2014 following corrections. 

File Size - 1.3 MB

US Labels Required to be FDA Reviewed

This FDA document lists which labels must be reviewed by the FDA for FDA licensed facilities.

US Codabar to ISBT 128 Map  To access this file, you must right click and save to the desired file on your computer

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  This document is no longer maintained; it was last updated in January 2007.

File Size - 503 kB

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US Codabar to ISBT 128 Map Version Control Sheet

This document explains changes for various versions of the US Codabar ISBT 128 Map.

United States Documents - Cellular Therapy

United States Consensus Standard for the Uniform Labeling of Cellular Therapy Products Draft version 1.3.0

The United States Consensus Standard for the Uniform Labeling of Cellular Therapy Products Draft version 1.3.0. has undergone FDA and public comment periods but is still available for your convenience.  

File Size - 3MB

US Consensus Standard for Cellular Therapy

Version 1.2.0

The United States Consensus Standard for the Uniform Labeling of Cellular Therapy Products Using ISBT 128 defines for the United States the areas that are the prerogative of national authorities.  It must be used in conjunction with ISBT 128 Standard Technical Specification to design labels for cellular therapy products.

File Size - 2MB

United Stated Documents - Tissues

AATB/ICCBBA Interim Guidance Document For Use of ISBT 128 by North America

The purpose of this document is to provide guidance on the implementation of the ISBT 128 Standard for tissues to those banks 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.