Active standard | Published: 02/07/2018

ISO/TS 19844:2018-ed.3.0

Health informatics — Identification of medicinal products (IDMP) — Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances
(Informatique de santé — Identification des médicaments — Lignes directrices pour·la·mise·en·oeuvre de l´ISO 11238 relative aux éléments de données et structures pour l´identification unique et l´échange d´informations réglementées sur les substances)

Available languages: English

Available design: electronic design (pdf), Print design

from 7 086.50 CZK show on eshop

Detail information

Designation: ISO/TS 19844:2018-ed.3.0

Publication date: 02/07/2018

Pages: 887

Country: International technical standard

Where to buy?

You can buy at www.mystandards.biz

Anotation

Description / Abstract: 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. ISO 11238 provides the conceptual framework for defining Substances and Specified Substances and for assigning unique identifiers in the context of the ISO IDMP standards. ISO 11238 describes general concepts for defining and distinguishing substances and a high-level model for the structuring of information for substances. This document provides detailed explanations of each type or grouping of substance information, an element-by-element description for implementation of ISO 11238, and examples for a variety of Substances and Specified Substances. This third edition of the document addresses Substances Groups 1 to 3 of the Specified Substances as defined in ISO 11238 and Annexes A, B, C, D, E, F, G, H, I, J and K. It is anticipated that Specified Substances Group 4, as defined in ISO 11238, will be addressed in a subsequent edition of this document. Some information that would typically fall under Specified Substances Group 4 is covered in the Annexes of this document. This information, although not defining of either a Substance or a Specified Substance Group 1, might be essential to distinguishing substances. This document addresses the following: - data elements necessary for defining Substances and Specified Substances Groups 1 to 3; - the logical use of data elements as defined in ISO 11238; - Substances and Specified Substances Groups 1 to 3 business rules for: - determining necessary data elements, - distinguishing and defining materials according to ISO 11238, - triggering the assignment of identifiers. This document does not address the following: - business processes for data management; - implementation of a specific data information system (e.g. a relational database schema); - normative messaging standards for substances; - the maintenance of controlled vocabularies; - the specific global identifier system that should be used; - nomenclature standards for substances.

Popular Publishers

full catalog