Technical Specification

Technical Specification - HCT/P Medical Devices

The following table can be used to view specific sections of the “ISBT 128 Standard Technical Specification” document (the full document is accessible at the bottom of this page) that pertain to data structures available for encoding UDI elements.

UDI Element	Section (of the “ISBT 128 Standard Technical Specification” document)
Device Identifier (DI)	2.4.34 “Processor Product Identification Code [Data Structure 034]”
Production Identifier (PI) – Distinct Identification Code	2.4.1 “Donation Identification Number [Data Structure 001]”
PI – Expiration Date	2.4.4 “Expiration Date [Data Structure 004]”
PI – Manufacturing Date	2.4.8 “Production Date [Data Structure 008]”
PI – Serial Number	2.4.32 “Product Divisions [Data Structure 032]”
PI – Lot or Batch Number	2.4.35 “MPHO Lot Number [Data Structure 035]”
Other Pertinent Information
The data structure that allows different data structures to be combined into a single message and may be used with high capacity delivery mechanisms such as 2-D bar codes and RFID tags.	Section 2.4.23 “Compound Message [Data Structure 023]”

This document is a comprehensive description of the rules surrounding the use of ISBT 128 as well as guidance in the interpretation of these rules.

Version 6.1.0: ST-001 ISBT 128 Standard Technical Specification – PDF (2 MB)

The purpose of this document is to provide standards and guidance for the coding and labeling of medical products of human origin (MPHO): blood, cellular therapy products, tissues, milk, and organs, as well as those plasma derivatives for which ABO is relevant.

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