This guidance document applies to the identification of human cells, tissues and cellular and tissue-based products (HCT/Ps) that are regulated as medical devices using a Unique Device Identifier (UDI) as required under the US Food and Drug Administration’s (FDA’s) Unique Device Identification System Final Rule (78 FR 58785; September 24, 2013).

The rationale that applies to the use of ISBT 128 for tissues regulated as medical devices applies equally to its use for traditional tissues. Therefore, ICCBBA also encourages the use of ISBT 128 for tissues regulated as biologics to provide a consistent means of coding all tissue for transplantation.

GS1 and ICCBBA, working within the terms of an existing Memorandum of Understanding, have developed this document to clarify the appropriate use of the GS1 and ISBT 128 unique device identifiers, and the interfaces between the standards.

The Boards of AABB, APBMT, ASFA, ASTCT, NMDP, EBMT, EMBMT, FACT, ICCBBA, ISBT, ISCT, JACIE, LABMT, WBMT, and WMDA issued an updated consensus statement in support of the use of ISBT 128 in the coding of hematopoietic progenitor cell and other therapeutic cell products. The Boards of the above organizations encourage cell therapy facilities to use ISBT 128 product coding and labeling. Please contact ICCBBA if you would like your society to be added to the list of supporting organizations.

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.

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.

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.