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.
Canadian Guidelines for the Uniform Labeling of Blood and Blood Components Using ISBT 128
The guidelines are available on the websites listed below:
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
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
UNITED STATES - BLOOD
The purpose of this document is to provide guidance on labeling requirements in the US for blood and blood components.
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.
The FDA document lists what labels must be reviewed by the FDA for FDA licensed facilities.
UNITED STATES - CELLULAR THERAPY
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.
UNITED STATES - TISSUES
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.
NATIONAL DOCUMENTS REQUIRING
The following documents need users to be logged into the technical site:
IG-025 Implementation Guide: US Guidance on Printing Text Associated with Red Cell Antigens - PDF
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.
IG-028 Implementation Guide: Use of ISBT 128 by North American Tissue Banks - v1.3.0 - PDF
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
IG-040 Implementation Guide: Use of ISBT 128 in North American Eye Banks - v1.4.0 – PDF
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.