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 publicly as well as documents only accessible by members. The "🔒" icon indicates that the document is accessible by registered users only.
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 – 7.51 [May 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 – 1.2.0 [Nov 2018]
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ST-005 – ISBT 128 Standard Labeling of Blood Components – 1.1.0 [Dec 2016]
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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 – 7.1.0 [Mar 2018]
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ST-011 – ISBT 128 Standard Coding and Labeling of Medical Devices Using ISBT 128 – 1.7.0 [Jun 2017]
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ST-012 – ISBT 128 and the Single European Code (SEC) – 1.3.1 [Dec 2016]
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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 – 1.0.0 [Dec 2020]
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ST-022 – ISBT 128 Standard Use of Clinical Trials Product Description Codes (PDCs) – 1.0.0 [Jan 2021]
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 – 1.0.2 [May 2017]
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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 – 🔒ISBT 128 Standard Coding and Labeling of Medical Devices Containing MPHO – 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 – 1.3.0 [Mar 2015]
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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]
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? – 1.3.0 [Feb 2021]
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TB-012 – ISBT 128 Implementation Plan – 1.0.0 [Feb 2018]
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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]