Technical Library

JP-007 Second Joint Statement on Terminology, Coding and Labeling of Human Donor Ocular Tissue

Joint statement between:

  • EBAA
  • EBAANZ
  • EEBA
  • ICCBBA
ST-009 ISBT 128 Standard Labeling of Ocular Tissue

This document is intended to help facilities and software developers design appropriate ISBT 128 labels for ocular tissue products. Greater detail is given for labeling than that provided in the ISBT 128 Technical Specification.

ST-010 ISBT 128 Standard Product Description Code Database
ST-011 ISBT 128 Standard Coding and Labeling of Medical Devices Using ISBT 128

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.

ST-012 ISBT 128 Standard ISBT 128 and the Single European Code (SEC)

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.

ST-017 ISBT 128 Standard Coding and Labeling of Medical Devices Containing MPHO

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.

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