TECHNICAL DOCUMENTS

Here you will find technical documents and files available to the public. Please select from the following subject areas below to view their respective documents. Alternatively, learn how ISBT 128 is used in a field other than your own! Browse through the Committees section to learn how ICCBBA’s volunteer advisors are helping to advance the ISBT 128 Standard.

ICCBBA acknowledges the importance of registered vendors to the process of delivering quality services to patients. Information affecting suppliers of products licensed to utilize ISBT 128 can be found in the Vendors section.  

 
BLOOD TRANSFUSION

IN-003 ISBT 128 for Blood Components, An Introduction – PDF

This document provides an overview of the ISBT 128 Standard and how it applies to blood products. It also describes the elements needed to achieve standardization and how the standard is used to encode information into machine-readable form.

ST-005 ISBT 128 Standard Labeling of Blood Components – PDF

This document is intended to help facilities, label vendors, and software developers design appropriate ISBT 128 labels for blood products.

ST-023 ISBT 128 Standard for Base Labels – PDF

The purpose of this document is to provide specifications for blood and cellular therapy base labels that carry ISBT 128 Data Structures.  The specifications contained in this document on the standardized placement of linear bar codes on the base label were previously defined in the documents ISBT 128 Standard Labeling of Blood Components (ST-005) and ISBT 128 Standard Labeling of Cellular Therapy Products (ST-004).

IG-002 United States Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 – PDF

The purpose of this document is to provide guidance on labeling requirements in the US for blood and blood components.

IG-021 Implementation Guide: Use of Product Code [Data Structure 003] - Blood - PDF

The purpose of this document is to provide guidance for the use of the Product Code [Data Structure 003] and its supporting database in the coding of blood components.

IG-027 Implementation Guide: Use of Red Cell Antigens with Test History [Data Structure 030] – PDF

The purpose of this document is to provide implementation guidance for users and software developers who wish to implement Red Cell Antigens with Test History [Data Structure 030]. This document provides background information and examples of the use of Red Cell Antigens with Test History [Data Structure 030]. It provides supplementary information only and is therefore intended to be used in conjunction with the ISBT 128 Standard Technical Specification (ST-001).


JP-003 Blood Bag Identification Using ISBT 128 and GS1 – PDF
This document is intended to provide guidance to blood bag manufacturers, their customers, and software developers on the bar coding of blood bags and their shipping containers. It deals with the relationship between information held in the GS1 carton codes and the ISBT 128 blood container label codes, and recommends ways to simplify the mapping between this information.

TB-003 Apheresis Platelets - US Guidance – PDF

This document provides information regarding ICCBBA’s current understanding for labeling Apheresis Platelets in the US. In addition, the document addresses items not covered in the United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128, Version 3.0.0.

CS-001 US Implementation of ISBT 128 – PDF
This case study looks at the methods and organizations involved in adopting the ISBT 128 international standard for blood transfusion in the United States.

CS-002 Scandinavia Case Study – PDF

This case study looks at the collaborations that were utilized when adopting the ISBT 128 international standard for blood transfusion in Scandinavia.

 
 
 
 
 
 
 
 
CELLULAR THERAPY

IN-005 ISBT 128 for Cellular Therapy, An Introduction – PDF

This document provides an overview of the ISBT 128 Standard and how it applies to cellular therapy products. It also describes the elements needed to achieve standardization and how the standard is used to encode information into machine-readable form.

ST-004 ISBT 128 Standard Labeling of Cellular Therapy Products – PDF

This document is intended to help facilities, label vendors, and software developers design appropriate ISBT 128 labels for cellular therapy products. Greater detail is given for labeling than that provided in the ISBT 128 Technical Specification.

ST-012 ISBT 128 and the Single European Code (SEC) – PDF

This document provides specific rules and guidance in the implementation of the SEC for ISBT 128 labeled products. This standard must be read in conjunction with the relevant EC and national legislation and regulatory requirements. It is the responsibility of the tissue establishment (TE) applying the SEC to ensure that labels comply with applicable regulation.

Note: A tool for creating the SEC for an ISBT 128 product can be found in the Lookup Tools section of the website. 
Click here to access the Single European Code (SEC) Builder Tool. 

 

ST-015 Standard Global Registration Identifier for Donors: ION Database and GRID Rules – PDF

The purpose of this document is to provide:

  • specifications for the structure of the Global Registration Identifier for Donors (GRID) and the Issuing Organization Number (ION);

  • information on how to obtain and update an ION; and,

  • rules on the use of the GRID.

Note: A tool for calculating the checksum based on the Issuing Organization Number (ION) and Registration Donor Identifier (RDI) entries can be found in the Lookup Tools section of the website. Click here to access the GRID Checksum Calculator.

ST-018 ISBT 128 Standard Labeling of Collection Products for Cellular Therapy Manufacturing – PDF

This document provides instructions for the labeling of apheresis collection products for sponsor cellular therapy clinical trials and manufacturing. 

ST-023 ISBT 128 Standard for Base Labels – PDF

The purpose of this document is to provide specifications for blood and cellular therapy base labels that carry ISBT 128 Data Structures.  The specifications contained in this document on the standardized placement of linear bar codes on the base label were previously defined in the documents ISBT 128 Standard Labeling of Blood Components (ST-005) and ISBT 128 Standard Labeling of Cellular Therapy Products (ST-004).

IG-003 United States Consensus Guidance for the Uniform Labeling of Cellular Therapy Products Using ISBT 128 – PDF

This document provides guidance for users, software developers, and label vendors in the US in those areas of cellular therapy product labeling that are not internationally defined.

IG-022 Implementation Guide: Product Coding [Data Structures 003 and 032] - Cellular Therapy – PDF

The purpose of this document is to provide guidance in the use of the Product Code [Data Structure 003] and its supporting database in the coding of cellular therapy products. This document also discusses Product Divisions [Data Structure 032] and its role in traceability when used in conjunction with Data Structure 003.

IG-023 Implementation Guide: Use of Product Divisions [Data Structure 032] – PDF

The purpose of this document is to provide guidance in the use of Product Divisions [Data Structure 032] so that software may be developed to support it. 

This document is a guidance document to be used in conjunction with the ISBT 128 Standard Technical Specification (ST-001). It provides information about the format and use of the Product Divisions [Data Structure 032] when used in conjunction with the Product Code [Data Structure 003].

 

IG-024 Implementation Guide: Use of Flexible Date and Time [Data Structure 031] – PDF

The purpose of this document is to provide guidance in the use of the Flexible Date and Time [Data Structure 031]. This document is a supplement to the ISBT 128 Standard Technical Specification (ST-001). It:

  • Provides specific guidance for cellular therapy, ocular tissue, regenerated tissues, and organ transplantation in the use of the Flexible Date and Time [Data Structure 031].

  • Provides guidance on printing bar codes and text for dates on labels.

  • Addresses some concerns for software developers.

 

IG-031 Implementation Guide: Use of the Processing Facility Information Code [Data Structure 033] – PDF

The purpose of this document is to provide guidance in the implementation and use of the Processing Facility Information Code [Data Structure 033]. This data structure is designed for use by Cellular Therapy and Tissues facilities to convey information about the facility that assigned the Product Code and may include a facility Product Code assigned by the processing or labeling facility.

JP-005 Consensus Statement on Terminology, Coding and Labeling of Cellular Therapy Products – PDF

The Boards of AABB, APBMT, ASFA, ASTCT, Be The Match (NMDP), EBMT, EMBMT, FACT, ICCBBA, ISBT, ISCT, JACIE, LABMT, WBMT, and WMDA issued an updated consensus statement in support of the use of ISBT 128 in the coding of hematopoietic progenitor cell and other therapeutic cell products. The Boards of the above organizations encourage cell therapy facilities to use ISBT 128 product coding and labeling. Please contact ICCBBA if you would like your society to be added to the list of supporting organizations.

 
 
 
 
 
 
 
 
 
 
 
MEDICAL DEVICES

ST-011 ISBT 128 Standard Coding and Labeling of Medical Devices Using ISBT 128 – PDF

The purpose of this document is to provide requirements and guidance for the labeling of medical devices containing a human tissue or cellular component using the ISBT 128 Standard. The document addresses US regulations for medical device identification.

Note: The following tools can be found in the Lookup Tools section of the website:

Coding and Labeling of Medical Devices Containing MPHO

 

ST-016 ISBT 128 Standard Labeling of Medical Products of Human Origin with INN and USAN Nonproprietary Names – PDF

This document is intended to provide instructions for the labeling of medical products of human origin (MPHO) with an approved International Nonproprietary Name (INN) and/or a United States Adopted Name (USAN).

ST-017 ISBT 128 Standard Coding and Labeling of Medical Devices Containing MPHO – PDF

This document is intended to help facilities with labeling medical devices that contain Medical Products of Human Origin (MPHO) that are regulated as medical devices. It focuses on Unique Device Identification (UDI) labeling.

JP-002 GS1 and ICCBBA Guidance: Identification of medical devices containing an HCT/P in the United States – PDF

This guidance document applies to the identification of human cells, tissues and cellular and tissue-based products (HCT/Ps) that are regulated as medical devices using a Unique Device Identifier (UDI) as required under the US Food and Drug Administration’s (FDA’s) Unique Device Identification System Final Rule (78 FR 58785; September 24, 2013).

The rationale that applies to the use of ISBT 128 for tissues regulated as medical devices applies equally to its use for traditional tissues. Therefore, ICCBBA also encourages the use of ISBT 128 for tissues regulated as biologics to provide a consistent means of coding all tissue for transplantation.   

GS1 and ICCBBA, working within the terms of an existing Memorandum of Understanding, have developed this document to clarify the appropriate use of the GS1 and ISBT 128 unique device identifiers, and the interfaces between the standards.

 

IG-014 Implementation Guide: Use of Data Matrix Symbols with ISBT 128 – PDF

The purpose of this document is to assist users and software developers to implement Data Matrix two-dimensional (2-D) symbology for delivery of ISBT 128 data structures for labeling of medical products of human origin as well as for patient wristbands. Labeling includes affixed, attached, and accompanying labeling.

 

IG-020 Implementation Guide: Encoding Product Information [Data Structures 003, 032, 033, and 034] - Tissues – PDF

The purpose of this document is to provide detailed information about ISBT 128 product coding for tissues. Specifically, it:

  • Describes the data structures used in product coding

  • Compares two methods of encoding product information

  • Describes the database that supports the internationally standardized Product Description Codes (PDC)

  • Explains how to select an appropriate PDC

  • Explains how to request new PDCs

  • Explains the use of the Facility-Defined Product Code (FPC)

  • Provides guidance on the coding of divisions (or packs)

 
 
 
 
 
MILK BANKING

ST-013 ISBT 128 Standard Labeling of Human Milk Banking Products – PDF

This document is intended to help facilities and software developers design appropriate ISBT 128 labels for human milk banking products. Greater detail is given for labeling than that provided in the ISBT 128 Technical Specification.

 

IN-031 ISBT 128 For Human Milk, An Introduction – PDF

This document provides an overview of the ISBT 128 Standard and how it applies to milk banking. It also describes the elements needed to achieve standardization and how the standard is used to encode information into machine-readable form.

International Consensus Statement on the Terminology, Coding and Labeling of Human Milk Donations – PDF

 
 
 
 
OCULAR

ST-009 ISBT 128 Standard Labeling of Ocular Tissue – PDF

This document is intended to help facilities and software developers design appropriate ISBT 128 labels for ocular tissue products. Greater detail is given for labeling than that provided in the ISBT 128 Technical Specification.

  

ST-012 ISBT 128 and the Single European Code (SEC) – PDF

This document provides specific rules and guidance in the implementation of the SEC for ISBT 128 labeled products. This standard must be read in conjunction with the relevant EC and national legislation and regulatory requirements. It is the responsibility of the tissue establishment (TE) applying the SEC to ensure that labels comply with applicable regulation.

Note: A tool for creating the SEC for an ISBT 128 product can be found in the Lookup Tools section of the website. 
Click here to access the Single European Code (SEC) Builder Tool. 

IG-024 Implementation Guide: Use of Flexible Date and Time [Data Structure 031] – PDF

The purpose of this document is to provide guidance in the use of the Flexible Date and Time [Data Structure 031]. This document is a supplement to the ISBT 128 Standard Technical Specification (ST-001). It:

  • Provides specific guidance for cellular therapy, ocular tissue, regenerated tissues, and organ transplantation in the use of the Flexible Date and Time [Data Structure 031].

  • Provides guidance on printing bar codes and text for dates on labels.

  • Addresses some concerns for software developers.

 

IG-032 Implementation Guide: Use of Product Code [Data Structure 003] - Ocular Tissue – PDF

The purpose of this document is to provide detailed information about ISBT 128 product coding for ocular tissue. Specifically, it:

  • Explains the Product Code [Data Structure 003] in detail

  • Provides a reference to information about the structure of the Product Description Code (PDC) database

  • Explains how to select an appropriate PDC

  • Explains how to request new PDCs

ORGAN TRANSPLANT

IG-024 Implementation Guide: Use of Flexible Date and Time [Data Structure 031] – PDF

The purpose of this document is to provide guidance in the use of the Flexible Date and Time [Data Structure 031]. This document is a supplement to the ISBT 128 Standard Technical Specification (ST-001). It:

  • Provides specific guidance for cellular therapy, ocular tissue, regenerated tissues, and organ transplantation in the use of the Flexible Date and Time [Data Structure 031].

  • Provides guidance on printing bar codes and text for dates on labels.

  • Addresses some concerns for software developers.

IN-032 ISBT 128 For Human Organs, An Introduction – PDF

This document provides an overview of the ISBT 128 Standard and how it applies to human organ products. It also describes the elements needed to achieve standardization and how the standard is used to encode information into machine-readable form.

PLASMA  DERIVATIVES

JP-001 Bar Coding Plasma Derivatives, Implementation Guide, Issue #1.0 – PDF

ISBT 128 defines Plasma Derivatives as, "A product that contains concentrated fractions of plasma proteins that have been separated using physico-chemical or other fractionation processes. It is made from pooling plasma from large numbers of donors and is traced based on the lot or batch number of the pooled product.”

It is recommended that those products for which ABO blood groups is not relevant (e.g., Rh Immune Globulin or Gamma Globulin) be labeled with GS1 bar codes. Conversely, plasma derivatives for which the ABO blood group is relevant should be labeled with ISBT 128. 

REGENERATIVE MEDICINE

IG-023 Implementation Guide: Use of Product Divisions [Data Structure 032] – PDF

The purpose of this document is to provide guidance in the use of Product Divisions [Data Structure 032] so that software may be developed to support it. 

This document is a guidance document to be used in conjunction with the ISBT 128 Standard Technical Specification (ST-001). It provides information about the format and use of the Product Divisions [Data Structure 032] when used in conjunction with the Product Code [Data Structure 003].

 
 
 
 
REPRODUCTIVE PRODUCTS

ISBT 128 Standard Terminology for ART

ICCBBA has published a paper in the journal "Human Reproduction Open". The paper addresses standard terminology for reproductive tissue and cell products for use in Assisted Reproductive Technology (ART). Please click here to view the article.
 

ST-012 ISBT 128 and the Single European Code (SEC) v1.4.0 – PDF
This document provides specific rules and guidance in the implementation of the SEC for ISBT 128 labeled products. This standard must be read in conjunction with the relevant EC and national legislation and regulatory requirements. It is the responsibility of the tissue establishment (TE) applying the SEC to ensure that labels comply with applicable regulation.

Note: A tool for creating the SEC for an ISBT 128 product can be found in the Lookup Tools section of the website. 
Click here to access the Single European Code (SEC) Builder Tool. 

TB-014 - Revised Reproductive Terminology v1.0.0 – PDF

The purpose of this document is to provide guidance to users on the changes made to the Reproductive Terminology in version 7.32 of the ISBT 128 Standard Terminology for Medical Products of Human Origin (ST-002).

TISSUES

IN-007 ISBT 128 for Tissues, An Introduction – PDF

This document provides an overview of the ISBT 128 Standard and how it applies to tissue products. It also describes the elements needed to achieve standardization and how the standard is used to encode information into machine-readable form.

ST-003 ISBT 128 Standard Labeling of Human Tissues v1.1.0 – PDF

This document is intended to help facilities and software developers design appropriate ISBT 128 labels for tissue products.

ST-012 ISBT 128 and the Single European Code (SEC) v1.4.0 – PDF

This document provides specific rules and guidance in the implementation of the SEC for ISBT 128 labeled products. This standard must be read in conjunction with the relevant EC and national legislation and regulatory requirements. It is the responsibility of the tissue establishment (TE) applying the SEC to ensure that labels comply with applicable regulation.

Note: A tool for creating the SEC for an ISBT 128 product can be found in the Lookup Tools section of the website. 
Click here to access the Single European Code (SEC) Builder Tool. 

IG-014 Implementation Guide: Use of Data Matrix Symbols with ISBT 128 – PDF

The purpose of this document is to assist users and software developers to implement Data Matrix two-dimensional (2-D) symbology for delivery of ISBT 128 data structures for labeling of medical products of human origin as well as for patient wristbands. Labeling includes affixed, attached, and accompanying labeling.

IG-020 Implementation Guide: Encoding Product Information [Data Structures 003, 032, 033, and 034] - Tissues – PDF

The purpose of this document is to provide detailed information about ISBT 128 product coding for tissues. Specifically, it:

  • Describes the data structures used in product coding

  • Compares two methods of encoding product information

  • Describes the database that supports the internationally standardized Product Description Codes (PDC)

  • Explains how to select an appropriate PDC

  • Explains how to request new PDCs

  • Explains the use of the Facility-Defined Product Code (FPC)

  • Provides guidance on the coding of divisions (or packs)

IG-024 Implementation Guide: Use of Flexible Date and Time [Data Structure 031] – PDF

The purpose of this document is to provide guidance in the use of the Flexible Date and Time [Data Structure 031]. This document is a supplement to the ISBT 128 Standard Technical Specification (ST-001). It:

  • Provides specific guidance for cellular therapy, ocular tissue, regenerated tissues, and organ transplantation in the use of the Flexible Date and Time [Data Structure 031].

  • Provides guidance on printing bar codes and text for dates on labels.

  • Addresses some concerns for software developers.

IG-028 Implementation Guide: Use of ISBT 128 by North American Tissue Banks – PDF

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:

  • Donation identification numbering

  • Data structures that may be useful to tissue banks

  • Label design options

  • Software design

IG-031 Implementation Guide: Use of the Processing Facility Information Code [Data Structure 033] – PDF

The purpose of this document is to provide guidance in the implementation and use of the Processing Facility Information Code [Data Structure 033]. This data structure is designed for use by Cellular Therapy and Tissues facilities to convey information about the facility that assigned the Product Code and may include a facility Product Code assigned by the processing or labeling facility.

TB-013 - Revised Tissues Terminology Products That Contain Bone and Soft Tissue Combinations – PDF

The purpose of this document is to provide guidance to users on the changes made to the tissues terminology in version 7.35 of the ISBT 128 Standard Terminology for Medical Products of Human Origin (ST-002).

GS1 and ICCBBA Guidance: Identification of medical devices containing an HCT/P in the United States – PDF

This guidance document applies to the identification of human cells, tissues and cellular and tissue-based products (HCT/Ps) that are regulated as medical devices using a Unique Device Identifier (UDI) as required under the US Food and Drug Administration’s (FDA’s) Unique Device Identification System Final Rule (78 FR 58785; September 24, 2013).

The rationale that applies to the use of ISBT 128 for tissues regulated as medical devices applies equally to its use for traditional tissues. Therefore, ICCBBA also encourages the use of ISBT 128 for tissues regulated as biologics to provide a consistent means of coding all tissue for transplantation.   

GS1 and ICCBBA, working within the terms of an existing Memorandum of Understanding, have developed this document to clarify the appropriate use of the GS1 and ISBT 128 unique device identifiers, and the interfaces between the standards.

 

JP-002 GS1 and ICCBBA Guidance: Identification of medical devices containing an HCT/P in the United States – PDF

This guidance document applies to the identification of human cells, tissues and cellular and tissue-based products (HCT/Ps) that are regulated as medical devices using a Unique Device Identifier (UDI) as required under the US Food and Drug Administration’s (FDA’s) Unique Device Identification System Final Rule (78 FR 58785; September 24, 2013).

The rationale that applies to the use of ISBT 128 for tissues regulated as medical devices applies equally to its use for traditional tissues. Therefore, ICCBBA also encourages the use of ISBT 128 for tissues regulated as biologics to provide a consistent means of coding all tissue for transplantation.   

GS1 and ICCBBA, working within the terms of an existing Memorandum of Understanding, have developed this document to clarify the appropriate use of the GS1 and ISBT 128 unique device identifiers, and the interfaces between the standards.

 
 
 
 
 
 
CLINICAL TRIALS

ST-022 ISBT 128 Standard Use of Clinical Trials Product Description Codes (PDCs) – PDF

This standard provides guidance on the use of a new category of Product Description Codes (PDCs) specifically developed for clinical trials products. These Clinical Trials PDCs are standardized global identifiers allocated by ICCBBA, which may be used by organizations licensed with ICCBBA, including clinical trials facilities, clinical trial sponsors, and cell and gene therapy manufacturers.

TB-018 - Labeling of Clinical Trial and Manufactured Cellular Therapy (CT) Final Products Using ISBT 128 – PDF

This document helps users recognize various labeling scenarios that may apply to cellular therapy products.

ELECTRONIC MESSAGING DOCUMENTS

ST-020 ISBT 128 Standard for XML – PDF

The purpose of this standard is to provide specifications of XML elements for use in electronic messages in order to provide information regarding MPHO in a consistent and standardized format.

ST-027 ISBT 128 Dictionary of Standard Data Elements – PDF

The purpose of this document is to provide a dictionary of standard data elements. The document describes the data elements defined within ISBT 128 and identifies the corresponding unique resource identifier for each element. These data elements are for use in electronic messages.

 
 
GENERAL GUIDANCE DOCUMENTS

IG-008 Technical Bulletin 5: Bar Code Scanner Implementation of ISBT 128 Concatenation – PDF

The purpose of this document is to discuss the concatenation function as outlined in the ISBT 128 Application Specification and its impact on the three major type of scanning devices: contact scanners (“wands,” “pens”), near-contact scanners (CCDs), and non-contact scanners (lasers, “guns” and non-contact CCDs).

IG-010 Implementation Guide: Use of Flags in the Donation Identification Number for Process Control of Critical Points During Processing and Distribution – PDF

This document provides an overview of one way in which flag characters of the ISBT 128 Donation Identification Number [Data Structure 001] can be used for process control.

IG-011 Technical Bulletin 8: Specification for ISBT 128 Data Structures to support the secure bedside matching of patient and transfusion/transplant product identification – PDF

This specification defines new data structures that carry both the transfusion information and its location. These data structures will allow new systems to be developed using standardized coding that will enhance patient safety.

IG-013 Implementation Guide: ISBT 128 Bar Codes: Valid and Invalid Examples – PDF

This guidance should be used in conjunction with the latest version of the ISBT 128 Standard Technical Specification (ST-001), and the intended audience should already be familiar with the specifications of the Standard and have a comprehensive understanding of ISBT 128 data structures.

IG-015 Implementation Guide: Use of the Manufacturers Data File – PDF

The purpose of this document is to provide implementation guidance on the use of the Manufacturers Data File. Specifications pertaining to the Manufacturers Data File are contained in the ISBT 128 Standard Technical Specification (ST-001) and this information must be read for a complete understanding of the subject.

IG-017 Implementation Guide: Length of the Product Code Bar Code and Concatenation – PDF

The purpose of this document is to provide additional guidance recommending optimal bar code length and placement of Product Code [Data Structure 003] for concatenation.

IG-019 Implementation Guide: Manufacturer's Catalog Number and Lot Number (Items Other Than Containers) – PDF

This document is a supplement to the ISBT 128 Standard Technical Specification. It provides specific guidance for bar code placement to allow for concatenation. This document also addresses concerns for printer setup of the Auto 128 feature.

IG-020 Implementation Guide: Encoding Product Information [Data Structures 003, 032, 033, and 034] - Tissues – PDF

The purpose of this document is to provide detailed information about ISBT 128 product coding for tissues. Specifically, it:

  • Describes the data structures used in product coding

  • Compares two methods of encoding product information

  • Describes the database that supports the internationally standardized Product Description Codes (PDC)

  • Explains how to select an appropriate PDC

  • Explains how to request new PDCs

  • Explains the use of the Facility-Defined Product Code (FPC)

  • Provides guidance on the coding of divisions (or packs)​​

IG-025 Implementation Guide: US Guidance on Printing Text Associated with Red Cell Antigens – PDF

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.

IG-026 Implementation Guide: Use of Dimensions [Data Structure 029] – PDF

The purpose of this document is to provide implementation guidance for users and software developers who wish to implement Dimensions [Data Structure 029]

IG-029 Implementation Guide: Choosing an On-Demand Label Printer - PDF

The purpose of this document is to provide guidance for users who wish to procure on-demand label printers.

IG-031 Implementation Guide: Use of the Processing Facility Information Code [Data Structure 033] - PDF

The purpose of this document is to provide guidance in the implementation and use of the Processing Facility Information Code [Data Structure 033]. This data structure is designed for use by Cellular Therapy and Tissues facilities to convey information about the facility that assigned the Product Code and may include a facility Product Code assigned by the processing or labeling facility.​

IG-033 Implementation Guide: Use of the Donation Identification Number [Data Structure 001] – PDF

The purpose of this document is to provide guidance for the use of the Donation Identification Number [Data Structure 001].

IG-034 Implementation Guide: ISBT 128 Facility Identification Number – PDF

The purpose of this document is to provide guidance for the use of Facility Identification Numbers found in a number of ISBT 128 data structures.

IG-040 Implementation Guide: Use of ISBT 128 in North American Eye Banks – PDF

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.

IG-041 Implementation Guide: Use of ISBT 128 in Resource-Limited Countries – PDF

The purpose of this document is to provide guidance for implementation of the ISBT 128 Standard for blood transfusion in resource-limited countries. It is intended to provide options allowing facilities to promote safety, traceability, and efficiency without needing to implement all features of the ISBT 128 Standard.

IG-043 Implementation Guide: A Validation Tool for ISBT 128 Data Structures – PDF

The purpose of this document is to provide a mechanism to validate software reading bar-coded labels. Regulatory and compliance staff, as well as software developers, may find this guidance document helpful when developing certain validation test plans.

IG-045 Applying ISBT 128 Labels to Collection Products for Further Manufacture – PDF

The purpose of this document is to provide guidance to help users implementing standardized labeling of collection products for further manufacture in compliance with the ISBT 128 Standard Labeling of Collection Products for Cellular Therapy Manufacturing (ST-018)

IG-046 Shipping ISBT 128 Labeled Products Through a GS1 Supply Chain – PDF
This document is intended to provide guidance to help users distribute ISBT 128 labeled products through a GS1 supply chain. It outlines how the ISBT 128 products can be packaged using a GS1 Serial Shipping Container Code (SSCC) and the associated ISBT 128 information can be incorporated into GS1 electronic dispatch information.

 
 
 
 
 
 
 
GENERAL TECHNICAL BULLETINS

TB-004 ISBT 128 and Traceability – PDF

This document provides information on how ISBT 128 supports traceability through the combined use of a globally unique Donation Identification Number (DIN) and a Product Code.

TB-006 What is an ISBT 128 Donation Identification Number?  – PDF

This document provides information regarding the ISBT 128 Donation Identification Number (DIN). In addition, the document provides a brief description on Flag Characters and the Check Character.

TB-015 Bacterial testing strategies for Platelets - US Guidance – PDF

The purpose of this interim guidance is to assist US based blood facilities in the selection of the correct labels for labeling platelets in the US based on the FDA Guidance: Bacterial Risk Control Strategies for Blood Collection Establishment and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion (September 2019).

TB-016 Improving Quality of Care through Traceability – PDF

ICCBBA has published a new technical bulletin, TB-016 Improving Quality of Care through Traceability, to describe how the use of ISBT 128 facilitates the inclusion of product identifiers into patient electronic health records.  Developments described within this document would have an immediate beneficial impact on traceability and would facilitate the electronic exchange of health information to improve quality of care for patients around the world.

GENERAL JOINT PUBLICATIONS

JP-004 Assigning a Patient Identification Number – PDF

This document visits two mechanisms for assigning patient identification numbers – a globally unique option using the GS1 Global Service Relation Number (GSRN) and a locally assigned number using the ISBT 128 data structure. 

GENERAL INTRODUCTORY DOCUMENTS

IN-037 ISBT 128 Implementation Plan – PDF

This is a comprehensive implementation plan and the applicable steps may vary due to different needs in facilities. Therefore, facilities should use it as a guide or checklist of things to consider rather than attempting to follow it precisely.