Accuracy and traceability are non-negotiable in healthcare settings where blood products are collected, stored, and transfused. That’s why ISBT-128 was developed—a global standard designed to bring consistency, safety, and clarity to labeling medical products of human origin, including blood, plasma, stem cells, tissues, and more.
Complying with ISBT-128 isn’t just about checking boxes for blood banks and labs. It’s about protecting patients, supporting clinical teams, and creating systems that work under pressure. Whether you’re managing thousands of blood units or processing a single donor collection, understanding the key ISBT-128 labeling requirements can help you stay compliant and error-free.
ISBT-128 stands for International Society of Blood Transfusion 128, the global standard for identifying, coding, and labeling blood and related products. The system ensures that every product has a globally unique identifier, enabling full traceability from donor to recipient, which is crucial for patient safety and international consistency.
It also standardizes the layout of barcodes, text, and critical information like blood type, expiration date, and product type, reducing the chance of confusion when handling blood products from different facilities, vendors, or countries.
1. Globally Unique Donation Identification Number (DIN)
Each label must include a 13-character DIN that is unique worldwide. This number ensures every unit of blood or product can be traced back to its source.
2. Standardized Product Codes
Each blood product must be labeled with a code that identifies what it is—whether it’s red blood cells, plasma, or another component.
3. Expiration Date and Time
Labels must display in both barcode and human-readable text formats when a product is no longer safe to use.
4. ABO and RhD Blood Type
For transfusion compatibility, the blood group must be marked on every label, both in text and barcode.
5. Special Testing Information
If a unit has been tested or processed in a special way (e.g., irradiated, CMV-negative), that info must be clearly labeled and encoded.
6. Barcode Standards and Placement
Barcodes must use Code 128 symbology, follow size/spacing rules, and be placed in specific “zones” outlined by ICCBBA.
7. Human-Readable Text
Every barcode must be accompanied by readable text so data can still be verified if scanning fails.
8. Durability and Print Compatibility
Labels must withstand cold storage, transport, and handling—without peeling, smudging, or becoming unreadable.
9. Specimen Collection Compatibility
Labs often need to label associated specimens for cross-matching or confirmatory testing. These labels must integrate seamlessly into the ISBT-128 system.
Understanding ISBT-128 labeling requirements is only part of the equation—meeting them in real-world conditions depends on using the right materials. From formatting and barcode standards to durability in refrigeration and lab handling, every detail matters when patient safety is on the line.
At Nev’s Ink, you’ll find a range of labeling solutions developed specifically for the demands of blood banks and laboratories. That includes:
Whether you’re labeling blood units for transfusion, managing donor samples, or preparing specimens for cross-matching, we provide the tools that help keep your operation accurate, compliant, and efficient.
Need to update your labeling process? Start with labels that do the job right the first time.
