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.
AUSTRIA
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
CHINA
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)
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
DENMARK
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
ITALY
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
POLAND
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
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
PORTUGAL
Diário da República, 2.ª série — N.º 25 — 5 de fevereiro de 2018
SPAIN
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
UNITED KINGDOM
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.
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.
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.
US Labels Required to be FDA Reviewed
The FDA document lists what labels must be reviewed by the FDA for FDA licensed facilities.
UNITED STATES - CELLULAR THERAPY
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
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:
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Donation identification numbering
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Data structures that may be useful to tissue banks
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Label design options
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Software design
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.
UNITED STATES - EYEBANKS
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.