Standards Documents

List of ISBT 128 Standards Documents – PDF [16 Dec 2021]

This document is a comprehensive description of the rules surrounding the use of ISBT 128 as well as guidance in the interpretation of these rules. 

Version 6.1.0: ST-001 ISBT 128 Standard Technical Specification – PDF (2 MB)

The purpose of this document is to provide standards and guidance for the coding and labeling of medical products of human origin (MPHO): blood, cellular therapy products, tissues, milk, and organs, as well as those plasma derivatives for which ABO is relevant.

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-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-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.

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-010 ISBT 128 Standard Product Description Code Database v7.1.1 – PDF

The purpose of this document is to provide specifications and guidance for the use of the ISBT 128 Product Description Code Database. The document provides reference tables for the characteristics of each table comprising the database and describes the relationships between each of the database tables.

ST-011 ISBT 128 Standard Coding and Labeling of Medical Devices Using ISBT 128 v1.8.0 – 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:

• The Device Identifier Checker tool can be used to parse the various elements of the ISBT 128 Device Identifier (DI).
• The Multiple Device Identifier Checker tool can be used to check the validity of a list of ISBT 128 Device Identifiers (DIs) provided in a data file.
• The Unique Device Identifier (UDI) Generator tool can be used for creating the UDI for an ISBT 128 product.

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-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.

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-016 ISBT 128 Standard Labeling of Medical Products of Human Origin with INN and USAN Nonproprietary Names v1.0.0 – 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 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.

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.

ST-020 ISBT 128 Standard for XML v1.0.0 - 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-022 ISBT 128 Standard Use of Clinical Trials Product Description Codes (PDCs) v1.0.0 - 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.

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