DS/CEN ISO/TS 20443:2018

Sundhedsinformatik – Identifikation af lægemidler – Vejledning i implementering af ISO 11615-baserede dataelementer og -strukturer til unik identifikation og udveksling af reguleret lægemiddelinformation


Status:
Gældende
Type:
Standard
Sprog:
Engelsk
Kategori:
Pris fra:
kr. 1.129,00

Beskrivelse

ISO/TS 20443:2017 defines concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products.

Taken together, all ISO IDMP standards (ISO 11615, ISO 11616, ISO 11238, ISO 11239 and ISO 11240) define, characterise, and uniquely identify regulated Medicinal Products for human use from approval, to post-marketing and renewal or withdrawal from the market, where applicable.

Furthermore, to support successful information exchange in relation to the unique identification and characterisation of Medicinal Products, the normative use of HL7 common product model (CPM) and structured product labeling (SPL) messaging is described. References to the use of other relevant standards for Medicinal Product information are included in ISO/TS 20443:2017 to support successful information exchange.

Antal sider: 214

Udgivet: 2018-05-23

Godkendelsesdato: 2018-05-22

Internationale relationer : CEN ISO/TS 20443:2018 IDT ISO/TS 20443:2017 IDT

ICS: 35.240.80 - Anvendelse af IT inden for sundhedssektoren

Varenummer: M322487


Udvalg og komiteer

Komite

  • CEN/TC 251
  • CEN/TC 251/WG 1
  • ISO/TC 215
  • ISO/TC 215/WG 6

Dansk udvalg

DS/S-273