Acronym
ICCBBA
Type
Standards Development Organisation
International Council for Commonality in Blood Banking Automation (ICCBBA) is a global, non-profit standards development organisation responsible for developing and managing standards related to medical products of human origin. The most commonly known standard they are responsible for is ISBT 128 (International Society of Blood Transfusion).
ISBT 128 is the international information standard for the terminology, identification, coding and labelling of medical products of human origin (including blood, cell, tissue, milk, and organ products). The ISBT 128 standard has been designed to ensure the highest levels of accuracy, safety, and efficiency for the benefit of donors and patients worldwide. ISBT 128 provides international consistency to support the transfer, traceability and transfusion/transplantation of blood, cells, tissues and organs. It is used by hospitals, blood centres, tissue and cellular therapy facilities and plasma fractionators.
Find out more about ICCBBA.
Find out more about the ICCBBA Standards Development Process.
Resources
ABO and RhD Coding Values
Category
Reference Table
Organisation
ICCBBA
ID
RT500
Type
Standard
Access
Open
Status
Active
Created
October 2021
This table contains ABO and RhD blood group coding values.
Coding and Labeling of Medical Devices Containing MPHO v1.0.0
Category
Standard
Organisation
ICCBBA
ID
ISBT128
Type
Standard
Version
1.0.0
Access
Open
Status
Active
Created
February 2019
This document provides guidance on coding and labelling MPHO that are regulated as medical devices, or that form part of a medical device.
Data structures 024 and 025: Patient Date of Birth and Patient Identification Number, Location Code v2018
Category
Reference Table
Organisation
ICCBBA
ID
RT018
Type
Standard
Version
2018
Access
Open
Status
Active
Updated
March 2018
This document is a reference table containing the location codes for use in Patient Date of Birth (ISBT 128 Data Structure 024) and Patient Identification Number (ISBT 128 Data Structure 025).
Facility Type Codes Used in the Registered Facilities Database
Category
Reference Table
Organisation
ICCBBA
ID
RT058
Type
Standard
Access
Open
Status
Active
Created
May 2023
This table contains the definitions of the facility type codes used in the ISBT 128 Registered Facilities Database.
ICCBBA-specified Compound Messages v1.9.0
Category
Reference Table
Organisation
ICCBBA
ID
RT017
Type
Standard
Version
1.9.0
Access
Open
Status
Active
This table contains ICCBA-specified compound messages.
Implementation Guide - A validation tool for ISBT 128 Data Structures v1.3.0
Category
Implementation Guide
Organisation
ICCBBA
ID
ICCBBA IG-043
Type
Standard
Version
1.3.0
Access
Open
Status
Active
Created
February 2023
This document provides a mechanism for users to validate their ISBT 128 barcode-reading software. It will help make users aware of how their system responds to a given data structure. Regulatory and compliance staff, as well as software developers, may find this guidance document helpful when developing certain validation test plans.
Implementation Guide - Applying ISBT 128 Labels to Collection Products for Further Manufacture v1.0.0
Category
Implementation Guide
Organisation
ICCBBA
ID
ICCBBA IG-045
Type
Standard
Version
1.0.0
Access
Open
Status
Active
Created
January 2021
This document provides guidance on implementing standardised labelling of collection products for further manufacture in compliance with the ISBT 128 Standard Labeling of Collection Products for Cellular Therapy Manufacturing (ST-018).
Implementation Guide - Choosing an on-demand label printer v1.0.2
Category
Implementation Guide
Organisation
ICCBBA
ID
ICCBBA IG-029
Type
Standard
Version
1.0.2
Access
Open
Status
Active
Created
February 2019
This document provides guidance for laboratory and hospital users who wish to procure on_demand label printers for blood product container labels.
Implementation Guide - ISBT 128 bar codes: valid and invalid examples v1.1.0
Category
Implementation Guide
Organisation
ICCBBA
ID
ICCBBA IG-013
Type
Standard
Version
1.1.0
Access
Open
Status
Active
Created
September 2017
This document provides usable barcodes (both valid and invalid) to help users evaluate the capabilities of their ISBT 128 barcode_reading software.
Implementation Guide - ISBT 128 Facility Identification Number v1.3.0
Category
Implementation Guide
Organisation
ICCBBA
ID
ICCBBA IG-034
Type
Standard
Version
1.3.0
Access
Open
Status
Active
Created
June 2023
The Facility Identification Number (FIN) found in many ISBT 128 data structures. This document describes how the FIN is assigned and maintained, the database supporting the FIN, and how the FIN is used within ISBT 128 data structures to identify an organisation responsible for an action.
Implementation Guide - ISBT 128 Implementation Toolbox v1.0.0
Category
Implementation Guide
Organisation
ICCBBA
ID
ICCBBA IG-047
Type
Standard
Version
1.0.0
Access
Open
Status
Active
Created
October 2021
This document is a toolbox of commonly used items essential for implementing ISBT 128, it explains how to develop a comprehensive implementation plan, including recommended steps.
Implementation Guide - Length of the Product Code bar code and concatenation v1.1.0
Category
Implementation Guide
Organisation
ICCBBA
ID
ICCBBA IG-017
Type
Standard
Version
1.1.0
Access
Open
Status
Active
Created
August 2017
This document is a supplement to the ISBT 128 Standard Technical Specification. It provides specific guidance for barcode placement, optimal barcode length, and placement of Product Code [Data Structure 003] for concatenation.
Implementation Guide - Manufacturer's Catalog Number and Lot Number (items other than containers) v1.0.1
Category
Implementation Guide
Organisation
ICCBBA
ID
ICCBBA IG-019
Type
Standard
Version
1.0.1
Access
Open
Status
Active
Created
May 2017
This document provides background information and examples of the use of the Manufacturer and Catalog Number: Items Other Than Containers [Data Structure 021] and the Lot Number: Items Other Than Containers [Data Structure 022].
Implementation Guide - MPHO Unique Identifier v1.0.0
Category
Implementation Guide
Organisation
ICCBBA
ID
ICCBBA IG-048
Type
Standard
Version
1.0.0
Access
Open
Status
Active
Created
January 2022
This document provides guidance on creating and using the medical products of human origin (MPHO) Unique Identifier in compliance with the relevant ISBT standard. It explains the structure of the MPHO Unique Identifier and provides label examples.
Implementation Guide - Shipping ISBT 128 Labeled Products through a GS1 Supply Chain v1.0.0
Category
Implementation Guide
Organisation
ICCBBA
ID
ICCBBA IG-046
Type
Standard
Version
1.0.0
Access
Open
Status
Active
Created
February 2021
This document provides guidance on distributing ISBT 128-labelled products through a GS1 supply chain. It specifies how to package the products using a GS1 serial shipping container code (SSCC) and incorporate associated ISBT 128 information into GS1 electronic dispatch information.
Implementation Guide - US guidance on printing text associated with red cell antigens v1.1.0
Category
Implementation Guide
Organisation
ICCBBA
ID
ICCBBA IG-025
Type
Standard
Version
1.1.0
Access
Open
Status
Active
Created
February 2024
This document provides guidance for printing text and coding red blood cell antigen test results on the affixed blood label.
Implementation Guide - Use of Data Matrix symbols with ISBT 128 v1.3.0
Category
Implementation Guide
Organisation
ICCBBA
ID
ICCBBA IG-014
Type
Standard
Version
1.3.0
Access
Open
Status
Active
Created
September 2016
This document provides background information and examples of the use of Data Matrix with ISBT 128 data structures.
Implementation Guide - Use of Dimensions [Data Structure 029] v1.3.0
Category
Implementation Guide
Organisation
ICCBBA
ID
ICCBBA IG-026
Type
Standard
Version
1.3.0
Access
Open
Status
Active
Created
February 2019
This document provides implementation guidance for users and software developers who wish to implement Dimensions [Data Structure 029].
Implementation Guide - Use of flags in the Donation Identification Number for process control of critical points during processing and distribution v1.0.3
Category
Implementation Guide
Organisation
ICCBBA
ID
ICCBBA IG-010
Type
Standard
Version
1.0.3
Access
Open
Status
Active
Created
June 2021
This document provides an example of the use of flag characters in the Donation Identification Number (DIN) for process control of critical points during processing and distribution of blood products.
Implementation Guide - Use of Flexible Date and Time [Data Structure 031] v1.2.0
Category
Implementation Guide
Organisation
ICCBBA
ID
ICCBBA IG-024
Type
Standard
Version
1.2.0
Access
Open
Status
Active
Created
February 2019
This document provides guidance in the use of the Flexible Date and Time [Data Structure 031] in cellular therapy, ocular tissue, regenerated tissues and organ transplantation.
Implementation Guide - Use of ISBT 128 by North American tissue banks v1.4.0
Category
Implementation Guide
Organisation
ICCBBA
ID
ICCBBA IG-028
Type
Standard
Version
1.4.0
Access
Open
Status
Active
Created
June 2020
This document provides guidance for the final labelling of human tissue products in a way that is compliant with the ISBT 128 Standard in North American tissue banks.
Implementation Guide - Use of ISBT 128 in North American Eye Banks v1.4.0
Category
Implementation Guide
Organisation
ICCBBA
ID
ICCBBA IG-040
Type
Standard
Version
1.4.0
Access
Open
Status
Active
Created
November 2016
The Eye Bank Association of America (EBAA) requires its accredited eye banks to use ISBT 128. This document provides guidance to North American and other eye banks accredited by the EBAA to help them implement ISBT 128.
Implementation Guide - Use of ISBT 128 in resource_limited countries v1.0.2
Category
Implementation Guide
Organisation
ICCBBA
ID
ICCBBA IG-041
Type
Standard
Version
1.0.2
Access
Open
Status
Active
Created
September 2022
This document provides guidance for implementing the ISBT 128 Standard for blood transfusion in resource_limited countries. It provides options to allow facilities to promote safety, traceability and efficiency without needing to implement all features of the ISBT 128 Standard.
Implementation Guide - Use of Product Divisions [Data Structure 032] v1.2.0
Category
Implementation Guide
Organisation
ICCBBA
ID
ICCBBA IG-023
Type
Standard
Version
1.2.0
Access
Open
Status
Active
Created
November 2018
This document provides guidance to users and software developers on the use of the Product Divisions [Data Structure 032] for cellular therapy and regenerated tissue products, when used with the Product Code [Data Structure 003].
Implementation Guide - Use of Red Cell Antigens with Test History [Data Structure 030] v1.2.0
Category
Implementation Guide
Organisation
ICCBBA
ID
ICCBBA IG-027
Type
Standard
Version
1.2.0
Access
Open
Status
Active
Created
July 2016
This document provides implementation guidance for users and software developers who wish to implement Red Cell Antigens with Test History [Data Structure 030].
Implementation Guide - Use of the Manufacturers Data File v1.2.1
Category
Implementation Guide
Organisation
ICCBBA
ID
ICCBBA IG-015
Type
Standard
Version
1.2.1
Access
Open
Status
Active
Created
December 2016
This document provides background information and examples of the use of the ISBT 128 Manufacturers Data File for blood containers.
Implementation Guide - Use of the Processing Facility Information Code [Data Structure 033] v1.1.0
Category
Implementation Guide
Organisation
ICCBBA
ID
ICCBBA IG-031
Type
Standard
Version
1.1.0
Access
Open
Status
Active
Created
September 2016
This document provides specific guidance for cellular therapy and tissue (including ocular) facilities to implement and use the Processing Facility Information Code [Data Structure 033].
Implementation Guide - Using the ISBT 128 Chain of Identity (CoI) identifier v1.0.0
Category
Implementation Guide
Organisation
ICCBBA
ID
ICCBBA IG-050
Type
Standard
Version
1.0.0
Access
Open
Status
Active
Created
December 2023
This implementation guide is a supplement to the International Society of Blood Transfusion standard ISBT 128 standard technical specification.
ISBT 128 and the Single European Code (SEC) v1.4.0
Category
Standard
Organisation
ICCBBA
ID
ST-012
Type
Standard
Version
1.4.0
Access
Open
Status
Active
Updated
June 2021
This document specifies the way in which the Single European Code (SEC) should be formulated and printed on tissue and cell products labelled with International Society of Blood Transfusion Standard 128 (ISBT 128).
ISBT 128 Data References for use in Electronic Messages
Category
Reference Table
Organisation
ICCBBA
ID
RT042
Type
Standard
Access
Open
Status
Active
Created
December 2023
This table contains ISBT data references for use in electronic messages.
ISBT 128 Standard - Chain of Identity (CoI) Identifier v1.0.0
Category
Standard
Organisation
ICCBBA
ID
ICCBBA ST-028
Type
Standard
Version
1.0.0
Access
Open
Status
Active
Created
December 2022
This standard specifies the rules for the structure and use of the ISBT 128 Chain of Identity (CoI) Identifier and provides information on the associated Facility Identification Number (FIN).
ISBT 128 Standard - Coding and Labeling of Medical Devices Using ISBT 128 v1.9.0
Category
Standard
Organisation
ICCBBA
ID
ICCBBA ST-011
Type
Standard
Version
1.9.0
Access
Open
Status
Active
Created
April 2024
This document provides requirements and guidance to facilities, software developers and label vendors on how to use the ISBT 128 Standard to label medical devices that contain a human tissue or cellular component. It focuses on Unique Device Identification (UDI) labelling.
ISBT 128 Standard - Global Registration Identifier for Donors: ION Database and GRID Rules v3.2.0
Category
Standard
Organisation
ICCBBA
ID
ICCBBA ST-015
Type
Standard
Version
3.2.0
Access
Open
Status
Active
Created
September 2017
This standard describes the structure of the GRID Issuing Organization Database and provides instructions for: obtaining an Issuing Organization Number (ION), updating ION information in the database, and using a GRID for hematopoietic progenitor cell (HPC) donors and potential donors.
ISBT 128 Standard - ISBT 128 Dictionary of Standard Data Elements v1.3.0
Category
Standard
Organisation
ICCBBA
ID
ICCBBA ST-027
Type
Standard
Version
1.3.0
Access
Open
Status
Active
Created
December 2022
This document is a dictionary of standard data elements within ISBT 128, it describes each data element and identifies its corresponding unique resource identifier.
ISBT 128 Standard - Labeling of Blood Components v2.0.1
Category
Standard
Organisation
ICCBBA
ID
ICCBBA ST-005
Type
Standard
Version
2.0.1
Access
Open
Status
Active
Created
August 2023
This document provides guidance for facilities, transfusion services, label vendors, auditors and software developers on the design of labels for blood products following the standards in ISBT 128 Standard Technical Specification (ST-001).
ISBT 128 Standard - Labeling of Cellular Therapy Products v2.0.1
Category
Standard
Organisation
ICCBBA
ID
ICCBBA ST-004
Type
Standard
Version
2.0.1
Access
Open
Status
Active
Created
August 2023
This document provides guidance for facilities, label vendors and software developers on the design of labels for cellular therapy products following the standards in ISBT 128 Standard Technical Specification (ST-001).
ISBT 128 Standard - Labeling of Collection Products for Cellular Therapy Manufacturing v1.2.0
Category
Standard
Organisation
ICCBBA
ID
ICCBBA ST-018
Type
Standard
Version
1.2.0
Access
Open
Status
Active
Created
December 2023
This document provides instructions for labelling apheresis collection products for further processing by a clinical trials sponsor or a manufacturer.
ISBT 128 Standard - Labeling of Human Milk Banking Products v1.0.0
Category
Standard
Organisation
ICCBBA
ID
ICCBBA ST-013
Type
Standard
Version
1.0.0
Access
Open
Status
Active
Created
February 2016
This document provides facilities, software developers, nurses, label vendors and end users with guidance on the information that should appear on the final label of human milk products, in line with ISBT 128 requirements.
ISBT 128 Standard - Labeling of medical products of human origin with INN and USAN nonproprietary names v1.0.0
Category
Standard
Organisation
ICCBBA
ID
ICCBBA ST-016
Type
Standard
Version
1.0.0
Access
Open
Status
Active
Created
March 2018
This document provides instructions for the labelling of medical products of human origin that have an approved International Nonproprietary Name (INN) or a United States Adopted Name (USAN), or both.
ISBT 128 Standard - Labeling of Ocular Tissue v1.2.0
Category
Standard
Organisation
ICCBBA
ID
ICCBBA ST-009
Type
Standard
Version
1.2.0
Access
Open
Status
Active
Created
March 2023
This document provides guidance for facilities and label vendors on the design of labels for ocular tissue products following the standards in ISBT 128 Standard Technical Specification (ST001).
ISBT 128 Standard - Labeling of Reproductive Tissue and Cell Products v1.0.0
Category
Standard
Organisation
ICCBBA
ID
ICCBBA ST-019
Type
Standard
Version
1.0.0
Access
Open
Status
Active
Created
November 2022
This document provides guidance for facilities, hospitals, software developers and label vendors on the design of ISBT 128 labels for reproductive tissue and cell products.
ISBT 128 Standard - Labelling of Human Tissues v1.2.0
Category
Standard
Organisation
ICCBBA
ID
ICCBBA ST-003
Type
Standard
Version
1.2.0
Access
Open
Status
Active
Updated
February 2024
This document provides guidance to help facilities and software developers to design labels for tissue products in accordance with the ISBT 128 Standard Technical Specification.
ISBT 128 Standard - Product Description Code Database v7.1.1
Category
Standard
Organisation
ICCBBA
ID
ICCBBA ST-010
Type
Standard
Version
7.1.1
Access
Open
Status
Active
Created
June 2021
This document provides specifications and guidance for software developers and facilities on the structure of the ISBT 128 Product Description Code Database.
ISBT 128 Standard - Standard terminology for medical products of human origin v7.72
Category
Technical Specification
Organisation
ICCBBA
ID
ICCBBA ST-002
Type
Standard
Version
7.72
Access
Open
Status
Active
Created
January 2024
This document provides a standard terminology for describing transfusion and transplantation products. It helps users distinguish between products when required for safety, clinical practice, or inventory management.
ISBT 128 Standard - Technical specification v6.2.2
Category
Technical Specification
Organisation
ICCBBA
ID
ICCBBA ST-001
Type
Standard
Version
6.2.2
Access
Open
Status
Active
Created
April 2023
The ISBT 128 Standard is an international standard to convey information about medical products of human origin clearly and accurately. The standard is continually updated based on new and changing user needs.
ISBT 128 Standard - Use of Clinical Trials Product Description Codes (PDCs) v1.0.1
Category
Standard
Organisation
ICCBBA
ID
ICCBBA ST-022
Type
Standard
Version
1.0.1
Access
Open
Status
Active
Created
November 2022
This document provides guidance on the use of Clinical Trials Product Description Codes (PDCs) and describes the structure of the Clinical Trials PDC Database.
ISBT 128 Standard for base labels v1.0.1
Category
Standard
Organisation
ICCBBA
ID
ICCBBA ST-023
Type
Standard
Version
1.0.1
Access
Open
Status
Active
Created
August 2023
This document provides specifications for base labels that carry ISBT 128 Data Structures. It applies to base labels of containers that are intended to hold medical products of human origin, such as blood and cells.
ISBT 128 Standard for the Medical Products of Human Origin (MPHO) Unique Identifier v1.0.1
Category
Standard
Organisation
ICCBBA
ID
ICCBBA ST-026
Type
Standard
Version
1.0.1
Access
Open
Status
Active
Created
August 2023
This document provides standards for the coding of the Medical Products of Human Origin (MPHO) Unique Identifier.
ISBT 128 Standard for XML - Electronic messaging: Standardized XML elements for medical products of human origin v1.1.0
Category
Standard
Organisation
ICCBBA
ID
ICCBBA ST-020
Type
Standard
Version
1.1.0
Access
Open
Status
Active
Created
November 2021
This standard provides specifications of XML elements for use in electronic messages that provide information about medical products of human origin.
Manufacturer Identifier Codes - Table W1
Category
Reference Table
Organisation
ICCBBA
ID
RT016
Type
Standard
Access
Open
Status
Active
Created
December 2023
This table contains the identification codes assigned to manufacturers for use in the Container Manufacturer and Catalog Number (Data structure 017) and the Manufacturer and Catalog Number - Items other than Containers (Data structure 021).