Background: ISBT 128 is an international standard for the terminology, coding, labeling, and identification of medical products of human origin (MPHO). Full implementation of ISBT 128 improves traceability, transparency, vigilance and surveillance, and interoperability.
Methods: ICCBBA maintains the ISBT 128 standard through the activities of a network of expert volunteers, including representatives from professional scientific societies, governments and users, to standardize and maintain MPHO identification. These individuals are organized into Technical Advisory Groups and work within a structured framework as part of a quality-controlled standards development process.
Results: The extensive involvement of international scientific and professional societies in the development of the standard has ensured that ISBT 128 has gained widespread recognition. The user community has developed confidence in the ability of the standard to adapt to new developments in their fields of interest. The standard is fully compatible with Single European Code requirements for tissues and cells and is utilized by many European tissue establishments. ISBT 128's flexibility and robustness has allowed for expansions into subject areas such as cellular therapy, regenerative medicine, and tissue banking.
Conclusion: ISBT 128 is the internationally recognized standard for coding MPHO and has gained widespread use globally throughout the past two decades.
Keywords: Labeling; Standardization; Traceability; Transplantation.