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ISO TS 16791

Health informatics — Requirements for international machine-readable coding of medicinal product package identifiers

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Organization: ISO
Publication Date: 1 September 2020
Status: active
Page Count: 44
ICS Code (IT applications in health care technology): 35.240.80
scope:

This document provides guidelines on identification and labelling of medicinal products from the point of manufacture of packaged medicinal product to the point of dispensing the product.

This document outlines best practice for AIDC barcoding solutions for applications. Users can, however, consider the coding interoperability requirements for other AIDC technologies, e.g. Radio Frequency Identification (RFID).

Document History

ISO TS 16791
September 1, 2020
Health informatics — Requirements for international machine-readable coding of medicinal product package identifiers
This document provides guidelines on identification and labelling of medicinal products from the point of manufacture of packaged medicinal product to the point of dispensing the product. This...
ISO TS 16791
April 1, 2014
Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers
A description is not available for this item.

References

This document references:
11615 AMD 1 - Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information AMENDMENT 1
Published by ISO on August 1, 2022
A description is not available for this item.
This document references:
ISO 11616 - Health informatics - Identification of medicinal products - Data elements and structures for unique identification and exchange of regulated pharmaceutical product information
Published by ISO on October 1, 2017
This document is intended to provide specific levels of information relevant to the identification of a Medicinal Product or group of Medicinal Products. It defines the data elements, structures and...
This document references:
ISO 11238 - Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances
Published by ISO on July 1, 2018
This document provides an information model to define and identify substances within medicinal products or substances used for medicinal purposes, including dietary supplements, foods and cosmetics....
This document references:
11239 - Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging
Published by ISO on June 1, 2023
This document specifies: — the data elements, structures and relationships between the data elements required for the exchange of information, which uniquely and with certainty identify...
This document references:
ISO 11240 - Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement
Published by ISO on November 1, 2012
This International Standard: - specifies rules for the usage and coded representation of units of measurement for the purpose of exchanging information about quantitative medicinal product...
This document references:
11615 AMD 1 - Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information AMENDMENT 1
Published by ISO on August 1, 2022
A description is not available for this item.
This document references:
ISO 11616 - Health informatics - Identification of medicinal products - Data elements and structures for unique identification and exchange of regulated pharmaceutical product information
Published by ISO on October 1, 2017
This document is intended to provide specific levels of information relevant to the identification of a Medicinal Product or group of Medicinal Products. It defines the data elements, structures and...
This document is referenced by:
BS EN ISO 11616 - Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
Published by BSI on January 31, 2018
A description is not available for this item.
This document is referenced by:
BS EN ISO 17523 - Health informatics - Requirements for electronic prescriptions
Published by BSI on July 31, 2016
A description is not available for this item.
This document is referenced by:
BS PD CEN ISO/TS 19293 - Health Informatics - Requirements for a record of the dispense of a medicinal product
Published by BSI on June 30, 2018
A description is not available for this item.
This document is referenced by:
BS PD CEN ISO/TS 20443 - Health informatics – Identification of medicinal products – Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information
Published by BSI on May 31, 2018
A description is not available for this item.
This document is referenced by:
BS PD CEN ISO/TS 20451 - Health informatics – Identification of medicinal products – Implementation guidelines for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information
Published by BSI on May 31, 2018
A description is not available for this item.
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