Summary

ISBT 128 provides for unique identification of any donation worldwide and provides a comprehensive and highly flexible system for describing products and assigning Product Description Codes (PDCs). The scope of cellular therapy products labeled with ISBT 128 are products with cells in suspension. The PDCs assigned to cellular therapy products will begin with S (e.g., S1234). The class names and attributes used for coding cellular therapy products can be found in chapter 3 of the ST-002 ISBT 128 Standard Terminology for Medical Products of Human Origin document.

Related Technical Documentation

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. 

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.

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 7.86 of the Standard Terminology shall coincide with Version 7.86.x of the ISBT 128 Product Description Code Database.

This document provides a general introduction to the ISBT 128 Standard.

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.

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).

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.​

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