ISBT 128 provides for unique identification of any donation worldwide and provides a comprehensive and highly flexible system for describing products and assigning Product Description Codes (PDCs).

ISBT 128 provides for unique identification of any donation worldwide and provides a comprehensive and highly flexible system for describing products and assigning Product Description Codes (PDCs).

ISBT 128 provides a standardized class name of FECAL MICROBIOTA with attributes to account for characteristics such as cryoprotectants, storage, temperature, processing status, and preparation.

To enhance infant safety, donor human milk should be clearly identified, accurately labeled, and fully traceable. The ISBT 128 Standard provides globally unique identification of donor human milk products and to support their traceability and biovigilance.

While traditional medical devices will fall outside the scope of ISBT 128, there are some human tissues and cellular products that are regulated as a medical device rather than being regulated as a biologic.

Ocular tissues—such as corneas and sclera—are widely used in transplantation to restore vision and support ocular health. To enhance patient safety, these products should be clearly identified, accurately labeled, and fully traceable.

ISBT 128 provides standardized terminology and product description codes for organs and vessels for transplantation. Globally harmonized terminology for organs and vessels can be found in Chapter 12 of ISBT 128 Standard Terminology for Medical Products of Human Origin (ST-002).

ISBT 128 provides terminology and coding for a small subset of plasma derivatives, primarily where the ABO blood group is of significance such as with Solvent Detergent Pooled Plasma.

Tissue-engineered products (TEPs) are an emerging category of medical products of human origin. As development in this field advances, it is essential that these products are identified clearly.

As sperm, eggs, and embryos are increasingly shared across international borders and stored for extended periods, it is essential that they are clearly identified and can be effectively traced.

A critical part of safe transplantation is knowing what the tissue is, where it came from, and where it goes. The ISBT 128 Standard provides globally unique identification of tissue products and to support their traceability and biovigilance.