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Category
Standard
Standard
ISBT128
Version
1.0.0
Access
Open
Status
Active
Created
February 2019
All medical products of human origin (MPHO) must be traceable from donor to recipient. This requires standardised product terminology and coding.

This document provides guidance on coding and labelling MPHO that are regulated as medical devices, or that form part of a medical device. It focuses on Unique Device Identification (UDI) labelling. It is relevant to staff of tissue banks and cellular therapy facilities, as well as related regulators, label vendors and software developers.

Main sections:

• Device identifier

• Production identifiers

• Compound messages

• Parsing the ISBT 128 UDI to extract the data items

• Labelling

• Internationally standardized product description codes

• Administrative processes
Access Coding and Labeling of Medical Devices Containing MPHO v1.0.0

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