ONE WORLD. ONE STANDARD.
TABLE OF CONTENTS - DOCUMENT LIST
Welcome to the table of contents page. Here, the user will find a comprehensive list of all technical documents available. To find documents organized by subject area, visit the Technical Documents page.
LIST OF ISBT 128 STANDARDS
Document No. ––– Document Title ––– Active Version ––– Date Issued
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ST-001 – ISBT 128 Standard Technical Specification – 6.0.0 [Dec 2020]
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ST-002 – ISBT 128 Standard Terminology for Medical Products of Human Origin – 7.56 [Nov 2021]
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ST-003 – ISBT 128 Standard Labeling of Human Tissues – 1.1.0 [Jul 2017]
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ST-004 – ISBT 128 Standard Labeling of Cellular Therapy Products – 2.0.0 [Oct 2021]
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ST-005 – ISBT 128 Standard Labeling of Blood Components – 2.0.0 [Oct 2021]
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ST-009 – ISBT 128 Standard Labeling of Ocular Tissue – 1.1.0 [Oct 2016]
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ST-010 – ISBT 128 Standard Product Description Code Database – 7.1.1 [Jun 2021]
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ST-011 – ISBT 128 Standard Coding and Labeling of Medical Devices Using ISBT 128 – 1.8.0 [Aug 2021]
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ST-012 – ISBT 128 and the Single European Code (SEC) – 1.4.0 [Jun 2021]
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ST-013 – ISBT 128 Standard Labeling of Human Milk Banking Products – 1.0.0 [Feb 2016]
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ST-015 – Global Registration Identifier for Donors: ION Database and GRID Rules – 3.2.0 [Sep 2017]
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ST-016 – ISBT 128 Standard for INN/USAN – 1.0.0 [Mar 2018]
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ST-017 – ISBT 128 Standard Coding and Labeling of Medical Devices Containing MPHO – 1.0.0 [Feb 2019]
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ST-018 – ISBT 128 Standard Labeling for Apheresis Collection Products for Cellular Therapy Manufacturing – 1.0.0 [Nov 2020]
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ST-020 – ISBT 128 Standard for XML – 1.1.0 [Nov 2021]
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ST-022 – ISBT 128 Standard Use of Clinical Trials Product Description Codes (PDCs) – 1.0.0 [Jan 2021]
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ST-023 – ISBT 128 Standard for Base Labels – 1.0.0 [Oct 2021]
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ST-026 – ISBT 128 Standard for the Medical Products of Human Origin (MPHO) Unique Identifier – 1.0.0 [Oct 2021]
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ST-027 – ISBT 128 Dictionary of Standard Data Elements – 1.0.0 [Oct 2021]
If you are interested in a hard copy of the list of Standards Documents, download a PDF of the publications list here.
LIST OF ISBT 128 GUIDANCE DOCUMENTS
Document No. ––– Document Title ––– Active Version ––– Date Issued
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IG-002 – United States Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 – 3.0.0 [Mar 2013]
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IG-003 – United States Consensus Guidance for the Uniform Labeling of Cellular Therapy Products Using ISBT 128 – 1.3.1 [May 2015]
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IG-008 – Technical Bulletin 5: Bar Code Scanner Implementation of ISBT 128 Concatenation – 1 [May 2002]
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IG-010 – Implementation Guide: Use of Flags in the Donation Identification Number for Process Control of Critical Points During Processing and Distribution – 1.0.3 [Jun 2021]
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IG-011 – Technical Bulletin 8: Specification for ISBT 128 Data Structures to support the secure bedside matching of patient and transfusion/transplant product identification – 1.0.0 [Jan 2006]
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IG-013 – Implementation Guide: ISBT 128 Bar Codes: Valid and Invalid Examples – 1.1.0 [Sept 2017]
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IG-014 – Implementation Guide: Use of Data Matrix Symbols with ISBT 128 – 1.3.0 [Sep 2016]
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IG-015 – Implementation Guide: Use of the Manufacturers Data File – 1.2.1 [Dec 2016]
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IG-017 – Implementation Guide: Length of the Product Code Bar Code and Concatenation – 1.1.0 [Aug 2017]
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IG-019 – Implementation Guide: Manufacturer’s Catalog Number and Lot Number (NOT Containers) – 1.0.1 [May 2017]
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IG-020 – Implementation Guide: Encoding Product Information [Data Structures 003, 032, 033, and 034] for Tissues – 2.0.0 [Apr 2015]
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IG-021 – Implementation Guide: Use of Product Code [Data Structure 003] for Blood – 1.1.0 [Mar 2018]
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IG-022 – Implementation Guide: Product Coding [Data Structures 003 and 032] for Cellular Therapy – 1.2.0 [Apr 2015]
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IG-023 – Implementation Guide: Use of Product Divisions [Data Structure 032] – 1.2.0 [Nov 2018]
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IG-024 – Implementation Guide: Use of Flexible Date and Time [Data Structure 031] – 1.2.0 [Feb 2019]
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IG-025 – Implementation Guide: US Guidance on Printing Text Associated with Red Cell Antigens – 1.0.0 [Mar 2015]
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IG-026 – Implementation Guide: Use of Dimensions [Data Structure 029] – 1.3.0 [Feb 2019]
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IG-027 – Implementation Guide: Use of Red Cell Antigens with Test History [Data Structure 030] – 1.2.0 [Jul 2016]
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IG-028 – Implementation Guide: Use of ISBT 128 by North American Tissue Banks – 1.4.0 [June 2020]
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IG-029 – Implementation Guide: Choosing an On-Demand Label Printer – 1.0.2 [Feb 2019]
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IG-031 – Implementation Guide: Use of the Processing Facility Information Code [Data Structure 033] – 1.1.0
[Sep 2016]
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IG-032 – Implementation Guide: Use of Product Code [Data Structure 003] - Ocular Tissue – 1.2.0 [Nov 2016]
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IG-033 – Implementation Guide: Use of the Donation Identification Number [Data Structure 001] – 1.2.0 [Nov 2017]
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IG-034 – Implementation Guide: ISBT 128 Facility Identification Number – 1.2.0 [Sep 2016]
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IG-040 – Implementation Guide: Use of ISBT 128 in North American Eye Banks – 1.4.0 [Sep 2018]
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IG-041 – Implementation Guide: ISBT 128 in Resource Limited Countries – 1.0.0 [Feb 2018]
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IG-043 – Implementation Guide: A Validation Tool for ISBT 128 Data Structures – 1.1.0 [Nov 2017]
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IG-045 – Implementation Guide: Applying ISBT 128 Labels to Collection Products for Further Manufacture
– 1.0.0 [Jan 2021]
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IG-046 – Shipping ISBT 128 Labeled Products Through a GS1 Supply Chain – 1.0.0 [Feb 2021]
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IG-047 – Implementation Guide Toolbox v1.0.0 – 1.0.0 [Nov 2021]
If you are interested in a hard copy of the list of Guidance Documents, download a PDF of the publications list here.
LIST OF ISBT 128 TECHNICAL BULLETINS
Document No. ––– Document Title ––– Active Version ––– Date Issued
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TB-003 – Apheresis Platelets - US Guidance – 1.0.0 [Feb 2015]
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TB-004 – ISBT 128 and Traceability – 1.6.0 [June 2021]
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TB-006 – What is an ISBT 128 Donation Identification Number? – 1.4.0 [Feb 2021]
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TB-013 – Revised Tissues Terminology Products That Contain Bone and Soft Tissue Combinations – 1.0.0 [Apr 2020]
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TB-014 – Revised Reproductive Terminology – 1.0.0 [Jan 2020]
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TB-015 – Bacterial Contamination Strategies for Platelets – US Guidance – 1.0.0 [Nov 2020]
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TB-016 – Improving Quality of Care through Traceability – 1.0.0 [Oct 2020]
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TB-018 – Labeling of Clinical Trial and Manufactured Cellular Therapy (CT) Final Products Using ISBT 128 – 1.0.0 [Apr 2021]
LIST OF ISBT 128 JOINT PUBLICATIONS
Document No. ––– Document Title ––– Active Version ––– Date Issued
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JP-001 – GS1 Bar Coding Plasma Derivatives Implementation Guide – 1.0.0 [Aug 2010]
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JP-002 – GS1 and ICCBBA Guidance: Identification of medical devices containing an HCT/P in the United States
– 1 [Nov 2014]
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JP-003 – Blood Bag Identification Using ISBT 128 and GS1 – 1.0.1 [May 2017]
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JP-004 – Assigning a Patient Identification Number – 1.0.0 [Aug 2016]
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JP-005 – Consensus Statement on Terminology, Coding and Labeling of Cellular Therapy Products
– 1.0.1 [Jul 2021]
LIST OF ISBT 128 CASE STUDIES
Document No. ––– Document Title ––– Active Version ––– Date Issued
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CS-001 – US Implementation of ISBT 128 – 1.0.0 [Aug 2021]
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CS-002 – Scandinavia Case Study – 1.0.0 [Aug 2021]