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ISBT 128 Blood Labels
PDC Healthcare can help you meet the ISBT Blood Bank Standards with our complete line of blank and pre-printed labels. Available in single quadrant, double quadrant, and full-face configurations, our labels are precisely sized to run easily through your thermal printer to produce accurate bar codes and easy-to-read information.
ISBT 128 is a global barcode standard used for the identification, labeling and information processing of human blood, tissue and organ products across international borders and disparate health care systems. ISBT 128 is more secure, scans more accurately and can encode more information than the previous barcode system ABC CODABAR. ISBT 128 barcodes for blood products are copyrighted by ICCBBA (International Council for Commonality in Blood Bank Automation) who manages the standards. Use of ISBT 128 requires registration with ICCBBA. If you are a member of ICCBBA or AABB, you are required to use ISBT 128 for labeling blood products.
The ISBT 128 label is divided into 4 quadrants with 5 barcodes. Each quadrant is 2" X 2" in size. The upper left quadrant has the Donor Identification Number barcode. The upper right quadrant has the ABO/Rh Blood Group barcode. The lower left quadrant has the Product Code barcode (to identify blood product such as whole blood, red blood cells, plasma, platelets, etc.). The lower right quadrant has the Expiration Date and Special Testing barcodes.
If you're printing your own ISBT 128 labels, you will need blank labels. The label sizes available are 4" X 4" (to print all four quadrants), 4" X 2" (to print two quadrants) and 2" X 2" (to print one quadrant). Otherwise, if you do not print your own labels or want certain ABO/Rh Blood Groups or Product Code to be pre-printed, then you will need pre-printed labels.
For printing your own ISBT 128 labels, we recommend thermal transfer printing technology because the images and text generated are better quality and more durable.
Direct thermal printing technology is commonly used in printing retail store receipts that fade over time. Direct thermal labels are not recommended for blood bag labeling application because of its short shelf life and environmental instability. The generated barcode will deteriorate over time, causing scanning errors and information to be misread.
For ISBT 128 labels that go directly onto the blood bag, the FDA requires the label raw material manufacturer to submit a 510(k) application containing safety data to ensure the product composition is safe. For labels that go on the blood bag base label, the FDA requires the label material to comply with FDA 21 CFR 175.105. All PDC Healthcare ISBT 128 blood bag labels are approved for direct blood bag application.