Verkkokauppa
CEN ISO/TS 20451:2018:en
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 (ISO/TS 20451:2017)
Soveltamisala
Suomenkielistä soveltamisalaa ei ole saatavissa.
ISO/TS 20451:2017 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 ISO/TS 20451:2017.
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 ISO/TS 20451:2017.
Tämän julkaisun valmistelusta Suomessa vastaa SFS Suomen Standardit, puh. 09 149 9331.
ISO/TS 20451:2017 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 ISO/TS 20451:2017.
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 ISO/TS 20451:2017.
Tämän julkaisun valmistelusta Suomessa vastaa SFS Suomen Standardit, puh. 09 149 9331.
Sidokset
Velvoittavat viittaukset
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 11240:2012 Health informatics -- Identification of medicinal products -- Data elements and structures for the unique identification and exchange of units of measurement
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 11240:2012 Health informatics -- Identification of medicinal products -- Data elements and structures for the unique identification and exchange of units of measurement
Tekninen komitea
Vahvistuspäivä
25.05.2018
Julkaisupäivä
29.05.2018
Painos
1
Sivumäärä
53
Julkaisun kieli
englanti