ISBT 128 | ICCBBA | Table of Contents

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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

ST-001 – ISBT 128 Standard Technical Specification – 6.2.2 [Apr 2023]
ST-002 – ISBT 128 Standard Terminology for Medical Products of Human Origin – 7.70 [Sep 2023]
ST-003 – ISBT 128 Standard Labeling of Human Tissues – 1.1.0 [Jul 2017]
ST-004 – ISBT 128 Standard Labeling of Cellular Therapy Products – 2.0.1 [Aug 2023]
ST-005 – ISBT 128 Standard Labeling of Blood Components – 2.0.1 [Aug 2023]
ST-009 – ISBT 128 Standard Labeling of Ocular Tissue – 1.2.0 [Mar 2023]
ST-010 – ISBT 128 Standard Product Description Code Database – 7.1.1 [Jun 2021]
ST-011 – ISBT 128 Standard Coding and Labeling of Medical Devices Using ISBT 128 – 1.8.0 [Aug 2021]
ST-012 – ISBT 128 Standard ISBT 128 and the Single European Code (SEC) – 1.4.0 [Jun 2021]
ST-013 – ISBT 128 Standard Labeling of Human Milk Banking Products – 1.0.0 [Feb 2016]
ST-015 – ISBT 128 Standard Global Registration Identifier for Donors: ION Database and GRID Rules – 3.2.0 [Sep 2017]
ST-016 – ISBT 128 Standard for INN/USAN – 1.0.0 [Mar 2018]
ST-017 – ISBT 128 Standard Coding and Labeling of Medical Devices Containing MPHO – 1.0.0 [Feb 2019]
ST-018 – ISBT 128 Standard Labeling of Collection Products for Cellular Therapy Manufacturing – 1.1.0 [Dec 2022]
ST-019 – ISBT 128 Standard Labeling of Reproductive Tissue and Cell Products – 1.0.0 [Nov 2022]
ST-020 – ISBT 128 Standard for XML Electronic Messaging - Standardized XML Elements for Medical Products of Human Origin – 1.1.0 [Nov 2021]
ST-022 – ISBT 128 Standard Use of Clinical Trials Product Description Codes (PDCs) – 1.0.1 [Nov 2022]
ST-023 – ISBT 128 Standard for Base Labels – 1.0.1 [Aug 2023]
ST-026 – ISBT 128 Standard for the Medical Products of Human Origin (MPHO) Unique Identifier – 1.0.1 [Aug 2023]
ST-027 – ISBT 128 Standard ISBT 128 Dictionary of Standard Data Elements – 1.2.0 [Jun 2022]
ST-028 – ISBT 128 Standard Chain of Identity (CoI) Identifier – 1.0.0 [Dec 2022]

Standards List

Guidance List

LIST OF ISBT 128 GUIDANCE DOCUMENTS

Document No. ––– Document Title ––– Active Version ––– Date Issued

IG-002 – United States Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 – 3.0.0 [Mar 2013]
IG-003 – United States Industry Consensus Guidance for the Uniform Labeling of Cellular Therapy Products Using ISBT 128 – 1.3.1 [May 2015]
IG-008 – Technical Bulletin 5: Bar Code Scanner Implementation of ISBT 128 Concatenation – 1 [May 2002]
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]
IG-013 – Implementation Guide: ISBT 128 Bar Codes: Valid and Invalid Examples – 1.1.0 [Sep 2017]
IG-014 – Implementation Guide: Use of Data Matrix Symbols with ISBT 128 – 1.3.0 [Sep 2016]
IG-015 – Implementation Guide: Use of the Manufacturers Data File – 1.2.1 [Dec 2016]
IG-017 – Implementation Guide: Length of the Product Code Bar Code and Concatenation – 1.1.0 [Aug 2017]
IG-019 – Implementation Guide: Manufacturer’s Catalog Number and Lot Number (Items Other Than Containers) – 1.0.1 [May 2017]
IG-020 – Implementation Guide: Encoding Product Information [Data Structures 003, 032, 033, and 034] - Tissues – 2.0.0 [Apr 2015]
IG-021 – Implementation Guide: Use of Product Code [Data Structure 003] Blood – 1.2.0 [Sep 2022]
IG-022 – Implementation Guide: Product Coding [Data Structures 003 and 032] Cellular Therapy – 1.3.0 [Jun 2023]
IG-023 – Implementation Guide: Use of Product Divisions [Data Structure 032] – 1.2.0 [Nov 2018]
IG-024 – Implementation Guide: Use of Flexible Date and Time [Data Structure 031] – 1.2.0 [Feb 2019]
IG-025 – Implementation Guide: US Guidance on Printing Text Associated with Red Cell Antigens – 1.0.0 [Mar 2015]
IG-026 – Implementation Guide: Use of Dimensions [Data Structure 029] – 1.3.0 [Feb 2019]
IG-027 – Implementation Guide: Use of Red Cell Antigens with Test History [Data Structure 030] – 1.2.0 [Jul 2016]
IG-028 – Implementation Guide: Use of ISBT 128 by North American Tissue Banks – 1.4.0 [Jun 2020]
IG-029 – Implementation Guide: Choosing an On-Demand Label Printer – 1.0.2 [Feb 2019]
IG-031 – Implementation Guide: Use of the Processing Facility Information Code [Data Structure 033] – 1.1.0
[Sep 2016]
IG-032 – Implementation Guide: Use of Product Code [Data Structure 003] Ocular Tissue – 1.2.0 [Nov 2016]
IG-033 – Implementation Guide: Use of the Donation Identification Number [Data Structure 001] – 1.2.0 [Nov 2017]
IG-034 – Implementation Guide: ISBT 128 Facility Identification Number – 1.3.0 [Jun 2023]
IG-040 – Implementation Guide: Use of ISBT 128 in North American Eye Banks – 1.4.0 [Sep 2018]
IG-041 – Implementation Guide: ISBT 128 in Resource-Limited Countries – 1.0.2 [Sep 2022]
IG-043 – Implementation Guide: A Validation Tool for ISBT 128 Data Structures – 1.3.0 [Feb 2023]
IG-045 – Implementation Guide: Applying ISBT 128 Labels to Collection Products for Further Manufacture
– 1.0.0 [Jan 2021]
IG-046 – Implementation Guide: Shipping ISBT 128 Labeled Products Through a GS1 Supply Chain – 1.0.0 [Feb 2021]
IG-047 – Implementation Guide: ISBT 128 Implementation Toolbox v1.0.0 – 1.0.0 [Nov 2021]

IG-048 – Implementation Guide: MPHO Unique Identifier – 1.0.0 [Jan 2022]

LIST OF ISBT 128 TECHNICAL BULLETINS

Document No. ––– Document Title ––– Active Version ––– Date Issued

TB-003 – Apheresis Platelets - US Guidance: Use of Container Codes Versus Use of Division Codes – 1.0.0 [Feb 2015]
TB-004 – ISBT 128 and Traceability – 1.7.0 [February 2023]
TB-006 – What is an ISBT 128 Donation Identification Number? – 1.4.0 [Feb 2021]
TB-015 – Bacterial Contamination Strategies for Platelets – US Guidance – 1.0.0 [Nov 2020]
TB-016 – Improving Quality of Care through Traceability: How ISBT 128 Facilitates the inclusion of MPHO Identifiers in Patient Electronic Health Records – 1.1.0 [Jul 2023]
TB-018 – Labeling of clinical trial and manufactured cellular therapy (CT) final products using ISBT 128 – 1.1.0 [Feb 2023]

Anchor 1

LIST OF ISBT 128 JOINT PUBLICATIONS

Document No. ––– Document Title ––– Active Version ––– Date Issued

JP-001 – GS1 Bar Coding Plasma Derivatives Implementation Guide – 1.0.0 [Aug 2010]
JP-002 – Identification of medical devices containing an HCT/P in the United States: Recommendation for labelling Issued by ICCBBA and GS1 on 17 November 2014
– 1 [Nov 2014]
JP-003 – Blood Bag Identification Using ISBT 128 and GS1 – 1.0.1 [May 2017]
JP-004 – Assigning a Patient Identification Number – 1.0.0 [Aug 2016]
JP-005 – Third Consensus Statement on Terminology, Coding and Labeling of Cellular Therapy Products
– 1.0.2 [Feb 2022]
JP-007 – Second Joint Statement on Terminology, Coding and Labeling of Human Donor Ocular Tissue – 1.0.0 [Mar 2023]

LIST OF ISBT 128 CASE STUDIES

Document No. ––– Document Title ––– Active Version ––– Date Issued

CS-001 – US Implementation of ISBT 128 Case Study – 1.0.0 [Aug 2021]
CS-002 – Case Study: Implementation of ISBT 128 in Scandinavia – 1.0.0 [Aug 2021]

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