ISBT 128 sets a global standard for the identification, labeling and information processing of human blood, tissue and organ products across international borders and disparate health care systems.
In addition to specifying the requirements for the electronic coding of information, ISBT 128 provides a standard labeling format that insures a consistent layout of product labels with the bar codes and critical eye readable information such as blood type, product description, and expiration appearing in fixed positions on the label.
Any transfusion service that applies ISBT 128 labels to blood products must request a labeling variance from the FDA.
Download a sample letter for this in plain text format:
Sample Letter for FDA (text file)
For AABB members whose software will not be capable of labeling with ISBT 128 by the May deadline, read (AABB solution)
Download ISBT 128 product codes (PDF File)
Download informational posters and flyers in PDF format:
(requires Adobe Acrobat reader)
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