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ICCBBA, Inc.

ICCBBA enhances safety for patients by promoting and managing the ISBT 128 international information standard for use with medical products of human origin.

©2021 ICCBBA. All Rights Reserved.


National Documents

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.

Various countries have shared their documents for others to see. We welcome other countries to do the same.

 

Canada

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

The guidelines are available on the websites listed below:

(French) http://www.hema-quebec.qc.ca/sang/professionnels-sante/notice/notice-lignes-directrices.fr.html

(English) https://professionaleducation.blood.ca/en/transfusion/best-practices/uniform-labelling 

 

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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

 

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United Kingdom

The Guidelines for Blood Transfusion Services in the UK aims to define guidelines for all materials produced by the United Kingdom Blood Transfusion Services for both therapeutic and diagnostic use.

The document can be found on the following website:

http://www.transfusionguidelines.org.uk/red-book

 

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United States - 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) 

The purpose of this document is to provide guidance on labeling requirements in the US for blood and blood components.

 

TB-015 Bacterial testing strategies for Platelets - US Guidance v1.0.0 - PDF

The purpose of this interim guidance is to assist US based blood facilities in the selection of the correct labels for labeling platelets in the US based on the FDA Guidance: Bacterial Risk Control Strategies for Blood Collection Establishment and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion (September 2019). 

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IG-025 Implementation Guide: US Guidance on Printing Text Associated with Red Cell Antigens v1.0.0 - PDF

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The purpose of this document is to provide guidance for the printing of text and the coding of Red Blood Cell antigen test results on the affixed blood label.

 

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TB-003 Apheresis Platelets - US Guidance v1.0.0 – PDF

This document provides information regarding ICCBBA’s current understanding for labeling Apheresis Platelets in the US. In addition, the document addresses items not covered in the United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128, Version 3.0.0.

 

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US Labels Required to be FDA Reviewed - PDF

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

 

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United States - Cellular Therapy

IG-003 United States Consensus Guidance for the Uniform Labeling of Cellular Therapy Products Using ISBT 128 v1.3.1 – PDF (1 MB)

The purpose of this document is to provide guidance for users, software developers, and label vendors in the US in those areas of cellular therapy product labeling that are not internationally defined. 

 

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United States - Tissues

IG-028 Implementation Guide: Use of ISBT 128 by North American Tissue Banks v1.4.0 - PDF

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The purpose of this document is to provide guidance on the implementation of the ISBT 128 Standard for North American tissues banks. Specifically it provides guidance on:

  • Donation identification numbering
  • Data structures that may be useful to tissue banks
  • Label design options
  • Software design

 

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IG-040 Implementation Guide: Use of ISBT 128 in North American Eye Banks v1.4.0 – PDF

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The purpose of this document is to provide guidance to North American eye banks accredited by the Eye Bank Association of America (EBAA) in the implementation of ISBT 128. It is a joint document of the EBAA and ICCBBA.

 

FDA Guidance - PDF

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.

 

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