Cellular Therapy Documents
*You must be logged on to view this document
This document explains the new terminology and how it impacts the Product Description Code Database. It also includes crosswalk tables that compare the codes from v4.25.0 to the new codes in v4.26.0.
This document tells how the information standard is used to encode cellular therapy products and gives the background behind the development of the ISBT 128 information standard. It describes the elements needed to achieve standardization and explains how the standard is used to encode product information into machine readable form.
This document provides a labeling guideline for ISBT 128 cellular therapy products. Greater detail is given for labeling than that provided in the Technical Specification.
This will in part replace the Product Code Structure and Labeling Document.
The purpose of this document is to provide detailed information about ISBT 128 product coding for cellular therapy. Specifically, it explains:
• the Product Code Data Structure  in detail,
• the structure of the data base that supports the product description code,
• how to select an appropriate product description code, and
• how to request new product description codes.
This will in part replace the Product Code Structure aspect of the Product Code Structure and Labeling Document.
This guidance bulletin provides advice on implementation of ISBT 128 in such situations when cellular therapy processors may be receiving some donations that are not identified using ISBT 128.