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.​

As of November 2025, Lifeblood will be adding the ISBT 128 2D DataMatrix to existing fresh blood product competent label. The addition of the 2D DataMatrix will allow Australian Health Providers who have updated their laboratory information systems to begin using the best practice barcodes. Blood product labelling | National Blood Authority

The Therapeutic Goods Administration has released the Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025 and has designated ICCBBA one of three UDI issuing agencies. Complying with the Unique Device Identification timeframes for medical devices | Therapeutic Goods Administration (TGA)

Gesamte Rechtsvorschrift für Arzneimittel aus menschlichem Blut, Fassung vom 27.05.2022:

(German) https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=20004143

Hong Kong Dept. of Health Guidance for Cell and Tissue Products, Version of August 2021 Guidance for Cell and Tissue Products (advancedtherapyinfo.gov.hk)

Guidance for Industry on Labelling Requirements of Product Code, Unique Donation Identifier and Unique Recipient Identifier for Advanced Therapy Products Microsoft Word – PPB Guidance_Code_ATP-EN_210616.docx (ppbhk.org.hk)

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

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

Requisiti minimi organizzativi, strutturali e tecnologici del Programma di trapianto (PT) di CSE e delle Unità ad esso afferenti.

5 maggio 2021 https://www.gazzettaufficiale.it/eli/gu/2022/01/11/7/sg/pdf

Rozporzadezenie Ministra Zdrowia z dnia 6 czerwca 2017 w sprawie niepowtarzalnego oznakowania, sposobu oznaczania i monitorowania komórek, tkanek i narządów:

https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU20170001104/O/D20171104.pdf

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Rozporzadezenie Ministra Zdrowia z dnia 9 listopada 2016 w sprawie oznakowania krwi i jej składników:

https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU20160001845/O/D20161845.pdf

Diário da República, 2.ª série — N.º 25 — 5 de fevereiro de 2018

http://www.ipst.pt/files/IPST/LEGISLACAO/Legislacao_Nacional/Legislacao_Sangue/Despacho_1226_2018_servicos_sangue_codigo_ISBT_metodo_identicacao_unico_dadivas.pdf

Real Decreto por el que se establecen las normas de calidad y seguridad para la donación, la obtención, la evaluación, el procesamiento, la preservación, el almacenamiento y la distribución de células y tejidos humanos y se aprueban las normas de coordinación y funcionamiento para su uso en humanos.

https://www.boe.es/buscar/act.php?id=BOE-A-2014-7065

The third version of the ‘Specification for the Future Labelling of Blood Components Prepared in the United Kingdom’ is now available (Version 3, November 2021). It outlines the implementation timescale for both the implementation of a Transition State Label and the aim for the implementation of the Final State Label.

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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.

IG-002 United States Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128

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

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

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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US Labels Required to be FDA Reviewed

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

IG-003 United States Consensus Guidance for the Uniform Labeling of Cellular Therapy Products Using ISBT 128 

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. 

IG-028 Implementation Guide: Use of ISBT 128 by North American Tissue Banks 

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

FDA Guidance

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.

IG-040 Implementation Guide: Use of ISBT 128 in North American Eye Banks

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.

PUBLISHED PAPERS

 

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  • Ashford, P. Traceability. Cell and Tissue Banking (2010). Published online 14 July 2010.

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  • Slaper-Cortenbach, ICM. ICCBBA and ISBT 128 – value for money? Blood and Transplant Matters (Spring 2010). Page 13.

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  • Ashford, P. ISBT 128: contributing to the safety of transfusion and transplantation. ISBT 128 Science Series (2007) 2:113-116.

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  • Kumatagi, S. and McGrath, O. (2025). “Advancing Traceability in India: Scientific & Operational Role of the ISBT 128 Standard in Blood & Cellular Therapy.” Transfusion 360. Edition 5, Nov. 2025. pp. 7-9. TRANSFUSION-360_November-25.pdf

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  • EBA Board adopts Position Paper on the labelling, coding and identification of blood, blood components, tissues and cells. At the Board Meeting in Valletta, Malta, the EBA Board has voted to support the universal use of the ISBT 128 for labelling, coding and identification of blood, blood components, tissues and cells. EBA Position Paper on Coding and Labeling – PDF (01 Oct 2010)

  • Guidelines for the use of RFID technology in transfusion medicine. Vox Sang (2010) 98:1-24. (Special Issue)

  • Ashford, P. Gullikson J, Georgsen, J and Distler, P. Standard terminology for platelet additive solutions. Vox Sang (2010) 98(4):577-578.

  • Ashford P. Fearon M., Bedford R. Report on the joint IBEPAG/ICCBBA survey on import/export and blood component labeling. Vox Sang (2010) 98, 85–86.

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  • Butch, SH. and Distler, PB. ISBT 128 blood labeling: introduction and reference laboratory applications. Immunohematology (2006): 22:30-35

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  • Munk, Charles et al., ISBT 128: The Implementation Project of the Swiss Red Cross Blood Transfusion Service. ISBT Congress Proceeding, Journal of Blood Banks, and Transfusion Society of Turkey, July (2003)

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  • Distler, PB. ISBT 128 An internationally standardized means to label cellular therapy products. Pharmaceuticals Policy and Law (2007) 9:421-430.
     

  • Ashford P; Distler P; Gee A; Lankester A; Larsson S: Feller I; Loper K; Pamphilon D; Poston L; Rabe F; Slaper-Cortenbach I; Szczepiorkowski Z; Warkentin P; Terminology and labeling of cellular products: 1. Standards. Bone marrow transplantation 2007;40(11):1075-83.
     

  • Ashford P; Distler P; Gee A; Lankester A; Larsson S: Feller I; Loper K; Pamphilon D; Poston L; Rabe F; Slaper-Cortenbach I; Szczepiorkowski Z; Warkentin P; Terminology and labeling of cellular products 2: Implementation plan. Bone marrow transplantation 2007;40(11):1085-90.
     

  • Ashford P; Distler P; Gee A; Lankester A; Larsson S: Feller I; Loper K; Pamphilon D; Poston L; Rabe F; Slaper-Cortenbach I; Szczepiorkowski Z; Warkentin P; Standards for the terminology and labeling of cellular therapy products. Transfusion 2007;47(7):1319-27. (You must be a registered member with AABB to access this publication)
     

  • Ashford P; Distler P; Gee A; Lankester A; Larsson S: Feller I; Loper K; Pamphilon D; Poston L; Rabe F; Slaper-Cortenbach I; Szczepiorkowski Z; Warkentin P; ISBT 128 implementation plan for cellular therapy products. Transfusion 2007;47(7):1312-8.  (You must be a registered member with AABB to access this publication)
     

  • Ashford P; Distler P; Gee A; Lankester A; Larsson S: Feller I; Loper K; Pamphilon D; Poston L; Rabe F; Slaper-Cortenbach I; Szczepiorkowski Z; Warkentin P; ISBT 128 implementation plan for cellular therapy products. Journal of clinical apheresis 2007;22(5):258-64.
     

  • Ashford P; Distler P; Gee A; Lankester A; Larsson S: Feller I; Loper K; Pamphilon D; Poston L; Rabe F; Slaper-Cortenbach I; Szczepiorkowski Z; Warkentin P; Standards for the terminology and labeling of cellular therapy products. Journal of clinical apheresis 2007;22(5):249-57.

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  • Fehily, D., Ashford, P., Poniatowski, S. Traceability of Human Tissues for Transplantation – the development and implementation of a coding system using ISBT 128. Organs and Tissues (2004) (2) 83-88.​​​​

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  • Conway, Karen. The Human Side of UDI. Healthcare Purchasing News. Healthcare Purchasing News, July 2016

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