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.

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.

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.

This document is intended to provide instructions for the labeling of medical products of human origin (MPHO) with an approved International Nonproprietary Name (INN) and/or a United States Adopted Name (USAN).