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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

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Organization: ISO
Publication Date: 1 October 2017
Status: active
Page Count: 56
ICS Code (IT applications in health care technology): 35.240.80
scope:

This document defines the concepts required to associate pharmaceutical products with an appropriate set of PhPID(s) in accordance with ISO 11616.

Pharmaceutical identifiers and elements are to represent pharmaceutical products as represented in a Medicinal Product as indicated by a Medicines Regulatory Authority. The suite of ISO IDMP standards can be applied to off-label usage of Medicinal Products, but is currently outside of the scope of this document.

Reference to ISO 11238, ISO 11239, ISO 11240 and ISO 11615 and HL7 messaging standards, HL7 Reference Information Model (RIM), HL7 V3 Common Product Model (CPM) and HL7 V3 Structured Product Labelling (SPL) can be applied for pharmaceutical product information in the context of this document.

Document History

ISO TS 20451
October 1, 2017
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
This document defines the concepts required to associate pharmaceutical products with an appropriate set of PhPID(s) in accordance with ISO 11616. Pharmaceutical identifiers and elements are to...

References

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:
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 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 ISO on October 1, 2017
This document defines concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products....
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:
ENV 12610 - Medical Informatics - Medicinal Product Identification
Published by CEN on April 1, 1997
A description is not available for this item.
This document references:
ENV 13607 - Health Informatics - Messages for the Exchange of Information on Medicine Prescriptions
Published by CEN on May 1, 2000
A description is not available for this item.
This document references:
ISO 1087-1 - Terminology Work - Vocabulary - Part 1: Theory and Application
Published by ISO on October 15, 2000
This International Standard establishes a basic vocabulary for the theory and application of terminology work. It does not embrace the vocabulary dealing with computer applications in terminology...
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:
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 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 ISO on October 1, 2017
This document defines concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products....
This document is referenced by:
DIN CEN ISO/TS 19844 - Health informatics - Identification of medicinal products - Implementation guidelines for data elements and structures for the unique identification and exchange of regulated information on substances (ISO/TS 19844:2016); English version CEN ISO/TS 19844:2017, only on CD-ROM
Published by DIN on December 1, 2017
This document is used in the implementation of ISO 11238. This document defines substances based on their scientific identity (i.e. what they are) rather than on their use or method of production....
This document is referenced by:
BS EN ISO 11615 - Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information
Published by BSI on January 31, 2018
A description is not available for this item.
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