Click here to view information on ISBT 128 and the Single European Code (SEC).
Click here to view the documents pertaining to the revised cellular therapy terminology.
Click here to view example implementation plans.
Click here to view the Circular of Information for the Use of Cellular Therapy Products.
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:
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-022 Implementation Guide: Product Coding [Data Structures 003 and 032] - Cellular Therapy v1.2.0 - 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] v1.2.0 – 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].
TB-018 - Labeling of clinical trial and manufactured cellular therapy (CT) final products using ISBT 128 - v1.0.0 PDF
This document helps users recognize various labeling scenarios that may apply to cellular therapy products.
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-024 Implementation Guide: Use of Flexible Date and Time [Data Structure 031] v1.2.0 – 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:
IG-031 Implementation Guide: Use of the Processing Facility Information Code [Data Structure 033] v1.1.0 - 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-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).
ISBT 128 Implementation Plan for Cellular Therapy – docx
This document provides a sample ISBT 128 implementation plan concerning cellular therapy. It is intended to assist cellular therapy centers in creating their own ISBT 128 implementation plan.
The revised ISBT 128 cellular therapy terminology was implemented in August of 2013. Previous terminology was re-evaluated due to regulatory concerns regarding the use of TC (“therapeutic cell”) terminology. As a result of this review, the terminology was revised to eliminate the “TC” class designation and to create a more consistent format for cellular therapy class terms. The revised terminology also takes into consideration consistency with nomenclature used for tissue products (e.g., removing modifiers). For more details on the reason for the changes, see the presentation by Zbigniew M Szczepiorkowski, MD, PhD, FCAP. The following document pertains to the implemented revised terminology.
Supplementary Information:
Action List Strategy - PDF
The Action List Strategy is a suggested list of actions that should be considered when a facility implements the updated ISBT 128 terminology for cellular therapy.
Validation Strategy - docx
The Validation Strategy is intended for facilities that have already implemented ISBT 128 labeling and are seeking to validate only the changes to the terminology, OR have implemented ISBT 128 terminology (not full labeling) and are seeking to validate only the changes to the terminology.
Circular of Information for the Use of Cellular Therapy Products – PDF
Last Modified: October 2018
This circular was prepared jointly by the AABB, America’s Blood Centers, the American Association of Tissue Banks, the American Red Cross, the American Society for Apheresis, the American Society for Blood and Marrow Transplantation, the College of American Pathologists, the Cord Blood Association, the Foundation for the Accreditation of Cellular Therapy, ICCBBA, the International Society for Cellular Therapy, the Joint Accreditation Committee of ISCT and EBMT, the National Marrow Donor Program, and Netcord. Federal law prohibits dispensing the cellular therapy products described in this circular without a prescription.
