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.

This document provides instructions for the labeling of apheresis collection products for sponsor cellular therapy clinical trials and manufacturing.

This document is intended to help facilities and software developers design appropriate ISBT 128 labels for reproductive tissue and cell products.

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.

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.

The purpose of this document is to provide specifications for blood and cellular therapy base labels that carry ISBT 128 Data Structures.  The specifications contained in this document on the standardized placement of linear bar codes on the base label were previously defined in the documents ISBT 128 Standard Labeling of Blood Components (ST-005) and ISBT 128 Standard Labeling of Cellular Therapy Products (ST-004).