TECHNICAL LIBRARY - PUBLIC ACCESS

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 v1.1.0 – PDF

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

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.


JP-003 Blood Bag Identification Using ISBT 128 and GS1 v1.0.1 – 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 v1.0.0 – 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.

TB-012 ISBT 128 Implementation Plan v1.0.0 – PDF
This example plan was meant to be comprehensive, and not all steps may be needed by all facilities. Therefore, facilities should use it as a guide or checklist of things to consider rather than attempting to follow it precisely.

 
 
 
 
 
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 v1.2.1 – 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) 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. 

 

ST-015 Standard Global Registration Identifier for Donors: ION Database and GRID Rules v3.2.0 – 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 v1.0.0 – PDF

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

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.

JP-005 Consensus Statement on Terminology, Coding and Labeling of Cellular Therapy Products v1.0.1 – 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.

 
 
 
 
FECAL MICROBIOTA
 

TB-012 ISBT 128 Implementation Plan v1.0.0 – PDF

This example plan was meant to be comprehensive, and not all steps may be needed by all facilities. Therefore, facilities should use it as a guide or checklist of things to consider rather than attempting to follow it precisely.

 
IN VIVO DIAGNOSTIC MPHO

TB-012 ISBT 128 Implementation Plan v1.0.0 – PDF

This example plan was meant to be comprehensive, and not all steps may be needed by all facilities. Therefore, facilities should use it as a guide or checklist of things to consider rather than attempting to follow it precisely.

 
MEDICAL DEVICES

ST-011 ISBT 128 Standard Coding and Labeling of Medical Devices Using ISBT 128 v1.7.0 – 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-017 ISBT 128 Standard Coding and Labeling of Medical Devices Containing MPHO v1.0.0 – 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.

 

TB-012 ISBT 128 Implementation Plan v1.0.0 – PDF

This example plan was meant to be comprehensive, and not all steps may be needed by all facilities. Therefore, facilities should use it as a guide or checklist of things to consider rather than attempting to follow it precisely.

 
 
 
MILK BANKING

ST-013 ISBT 128 Standard Labeling of Human Milk Banking Products v1.0.0 – 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

TB-012 ISBT 128 Implementation Plan v1.0.0 – PDF

This example plan was meant to be comprehensive, and not all steps may be needed by all facilities. Therefore, facilities should use it as a guide or checklist of things to consider rather than attempting to follow it precisely.

 
OCULAR
 

ST-009 ISBT 128 Standard Labeling of Ocular Tissue v1.1.0 – 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) 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-012 ISBT 128 Implementation Plan v1.0.0 – PDF

This example plan was meant to be comprehensive, and not all steps may be needed by all facilities. Therefore, facilities should use it as a guide or checklist of things to consider rather than attempting to follow it precisely.

 
ORGAN TRANSPLANT

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.

TB-012 ISBT 128 Implementation Plan v1.0.0 – PDF

This example plan was meant to be comprehensive, and not all steps may be needed by all facilities. Therefore, facilities should use it as a guide or checklist of things to consider rather than attempting to follow it precisely.

 
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. 

TB-012 ISBT 128 Implementation Plan v1.0.0 – PDF

This example plan was meant to be comprehensive, and not all steps may be needed by all facilities. Therefore, facilities should use it as a guide or checklist of things to consider rather than attempting to follow it precisely.

 
REGENERATIVE MEDICINE

TB-012 ISBT 128 Implementation Plan v1.0.0 – PDF

This example plan was meant to be comprehensive, and not all steps may be needed by all facilities. Therefore, facilities should use it as a guide or checklist of things to consider rather than attempting to follow it precisely.

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-012 ISBT 128 Implementation Plan v1.0.0 – PDF
This example plan was meant to be comprehensive, and not all steps may be needed by all facilities. Therefore, facilities should use it as a guide or checklist of things to consider rather than attempting to follow it precisely.

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. 

TB-011 Revised Bone Tissue Terminology v1.0.0 – PDF

The purpose of this document is to provide guidance and cross reference between bone terminology used prior to August 2015 (in version 6.7.0 of the database and before) and that used after September 2015 (version 6.8.0 of the database and after). This document is intended to provide users with information that will help them transition from the old terminology to the new.

 

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.

 

TB-012 ISBT 128 Implementation Plan v1.0.0 – PDF

This example plan was meant to be comprehensive, and not all steps may be needed by all facilities. Therefore, facilities should use it as a guide or checklist of things to consider rather than attempting to follow it precisely.

TB-013 - Revised Tissues Terminology Products That Contain Bone and Soft Tissue Combinations v1.0.0 – 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).

 
 
 
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.

GENERAL GUIDANCE DOCUMENTS
 

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-045 Applying ISBT 128 Labels to Collection Products for Further Manufacture v1.1.0 – 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 v1.6.0 – 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? v1.4.0 – 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-012 ISBT 128 Implementation Plan v1.0.0 – PDF

This example plan was meant to be comprehensive, and not all steps may be needed by all facilities. Therefore, facilities should use it as a guide or checklist of things to consider rather than attempting to follow it precisely.

TB-015 Bacterial testing strategies for Platelets - US Guidance v1.0.0 - 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).