Ocular Documents

This section consists of documents that pertain to ocular products.


 

ST-009 ISBT 128 Standard Labeling of Ocular Tissue v1.1.0 – PDF

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-012 ISBT 128 and the Single European Code (SEC) v1.3.1 – PDF

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.

 

IG-024 Implementation Guide: Use of Flexible Date and Time [Data Structure 031] v1.1.0 – PDF

You must be logged in to view this document.

The purpose of this document is to provide guidance in the use of the Flexible Date and Time [Data Structure 031]. This document is a supplement to the ISBT 128 Standard Technical Specification (ST-001). It:

  • Provides specific guidance for cellular therapy, ocular tissue, regenerated tissues, and organ transplantation in the use of the Flexible Date and Time [Data Structure 031].
  • Provides guidance on printing bar codes and text for dates on labels.
  • Addresses some concerns for software developers.

 

IG-032 Implementation Guide: Use of Product Code [Data Structure 003] - Ocular Tissue v1.2.0 – PDF

You must be logged in to view this document.

The purpose of this document is to provide detailed information about ISBT 128 product coding for ocular tissue. Specifically, it:

  • Explains the Product Code [Data Structure 003] in detail
  • Provides a reference to information about the structure of the Product Description Code (PDC) database
  • Explains how to select an appropriate PDC
  • Explains how to request new PDCs

 

Example Implementation Plan – PDF

This example plan was meant to be comprehensive, and not all steps may be needed by all facilities. Therefore, facilities should use it as a guide or checklist of things to consider rather than attempting to follow it precisely.