Category
Standard
ID
ICCBBA ST-016
Type
Standard
Version
1.0.0
Access
Open
Status
Active
Created
March 2018
This document provides instructions for the labelling of medical products of human origin (MPHO) that have an approved International Nonproprietary Name (INN) or a United States Adopted Name (USAN), or both.
This standard is not intended to replace or modify existing labelling information such as the trade name, nonproprietary name and national identifiers. Instead, it is designed to capture essential product information in an electronically readable format, to ensure the unique identification of MPHO and to support traceability across international borders.
Main sections:
- Background
- Terminology
- Data structures
- Label design
- Label examples
This standard is not intended to replace or modify existing labelling information such as the trade name, nonproprietary name and national identifiers. Instead, it is designed to capture essential product information in an electronically readable format, to ensure the unique identification of MPHO and to support traceability across international borders.
Main sections:
- Background
- Terminology
- Data structures
- Label design
- Label examples
Access ISBT 128 Standard - Labeling of medical products of human origin with INN and USAN nonproprietary names v1.0.0
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