This section consists of documents that pertain to reproductive products.
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.
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.