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Category
Standard
Standard
ICCBBA ST-011
Version
1.9.0
Access
Open
Status
Active
Created
April 2024 
This document provides requirements and guidance to facilities, software developers and label vendors on how to use the ISBT 128 Standard to label medical devices that contain a human tissue or cellular component. It focuses on Unique Device Identification (UDI) labelling.

Main sections:

• Device identifier

• Production identifiers

• Compound messages

• Parsing the ISBT 128 UDI to extract the data items required by 45 CFR part 170

• Labelling

• Internationally standardised product description codes (PDCs)
Access ISBT 128 Standard Coding and Labeling of Medical Devices Using ISBT 128 v1.9.0

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