Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of units of measurement (ISO 11240:2012)
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specifies rules for the usage and coded representation of units of measurement for the purpose of exchanging information about quantitative medicinal product characteristics that require units of measurement (e.g. strength) in the human medicine domain; establishes requirements for units in order to provide traceability to international metrological standards; provides rules for the standardized and machine-readable documentation of quantitative composition and strength of medicinal products, specifically in the context of medicinal product identification; defines the requirements for the representation of units of measurement in coded form; provides structures and rules for mapping between different unit vocabularies and language translations to support the implementation of ISO 11240:2012, taking into account that existing systems, dictionaries and repositories use a variety of terms and codes for the representation of units.
The scope of ISO 11240:2012 is limited to the representation of units of measurement for data interchange between computer applications.
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Sisällysluettelo
Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and abbreviated terms
3.1 Terms and definitions
3.2 Abbreviations
4 Structures and vocabularies
4.1 Overview
4.2 Metrological concepts
4.3 Semantics of units of measurement
4.4 Vocabulary for units of measurement
4.5 Domain model
4.6 Data elements and technical data model
4.7 Operational attributes
Annex A Using units of measurement for expression of medicinal product strength (informative)
Annex B Examples to describe data elements (informative)
Annex C Example - Controlled terminology mapping (informative)
ISO 11238:2012 Health informatics -- Identification of medicinal products -- Data elements and structures for the unique identification and exchange of regulated information on substances
ISO 11239:2012 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
ISO 21090:2011 Health informatics -- Harmonized data types for information interchange
ISO 11238:2012 Health informatics -- Identification of medicinal products -- Data elements and structures for the unique identification and exchange of regulated information on substances
ISO 11239:2012 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
ISO 21090:2011 Health informatics -- Harmonized data types for information interchange
ISO 3166-1:2006 Codes for the representation of names of countries and their subdivisions -- Part 1: Country codes
ISO 3166-1:2006/Cor 1:2007
ISO 3166-2:2007 Codes for the representation of names of countries and their subdivisions -- Part 2: Country subdivision code
ISO 3166-3:1999 Codes for the representation of names of countries and their subdivisions -- Part 3: Code for formerly used names of countries
ISO 639-1:2002 Codes for the representation of names of languages -- Part 1: Alpha-2 code
ISO 639-2:1998 Codes for the representation of names of languages -- Part 2: Alpha-3 code
ISO 639-3:2007 Codes for the representation of names of languages -- Part 3: Alpha-3 code for comprehensive coverage of languages
ISO 639-4:2010 Codes for the representation of names of languages -- Part 4: General principles of coding of the representation of names of languages and related entities, and application guidelines
ISO 639-5:2008 Codes for the representation of names of languages -- Part 5: Alpha-3 code for language families and groups
ISO 639-6:2009 Codes for the representation of names of languages -- Part 6: Alpha-4 code for comprehensive coverage of language variants
ISO/IEC Guide 99:2007 International vocabulary of metrology -- Basic and general concepts and associated terms (VIM)