Standards Documents

List of ISBT 128 Standards Documents  PDF [22 September 2017]

 


Technical Specification

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 5.8.0: 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.


Standard Terminology

The Standard Terminology document provides definitions to all ISBT 128 terminology. The document should be used in conjunction with the ISBT 128 Product Description Code Database.

The version number of the Standard Terminology document will coincide with the first two numbers of the version of the applicable ISBT 128 Product Description Code Database. For example, Version 7.1 of the Standard Terminology shall coincide with Version 7.1.x of the ISBT 128 Product Description Code Database. 

Version 7.8: ST-002 ISBT 128 Standard Terminology for Medical Products of Human Origin – PDF

Standard Terminology Version Control Sheet 2017 – PDF

Standard Terminology Version Control Sheet 2016 – PDF
Standard Terminology Version Control Sheet 2015 – PDF 
Standard Terminology Version Control Sheet 2014 – PDF
Standard Terminology Version Control Sheet 2013 – PDF
Standard Terminology Version Control Sheet 2012 – PDF   
Standard Terminology Version Control Sheet 2011 – PDF
Standard Terminology Version Control Sheet (Prior to 2011) – PDF


Standard Labeling - Human Tissues

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.

 

Standard Labeling - Cellular Therapy Products

ST-004 ISBT 128 Standard Labeling of Cellular Therapy Products v1.1.0 – 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.

 

Standard Labeling - Blood Components

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.

 

Standard Labeling - Ocular Tissue

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.

 

Product Description Code Database

ST-010 ISBT 128 Standard Product Description Code Database v7.0.0 – 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.

 

Standard Coding and Labeling - 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.

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

 

ISBT 128 and the Single European Code

ST-012 ISBT 128 and the Single European Code (SEC) v1.3.1 – 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. 

 

Standard Labeling - Human Milk Banking Products

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.

 

Global Registration Identifier for Donors: ION Database and GRID Rules

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.