Standard Svensk standard · SS-EN ISO 11615:2017

Hälso- och sjukvårdsinformatik - Identifiering av läkemedel - Dataelement och strukturer för identifiering och utbyte av information på reglerade medicinska produkter (ISO 11615:2017)

Status: Gällande

Omfattning
ISO 11615:2017 establishes definitions and 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, the standards listed in the Introduction define, characterise and uniquely identify regulated Medicinal Products for human use during their entire life cycle, i.e. from development to authorisation, 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 use of other normative IDMP messaging standards is included, which are to be applied in the context of ISO 11615:2017.

Ämnesområden

Hälso- och sjukvårdsinformatik (35.240.80)


Produktinformation

Språk: Engelska

Framtagen av: Hälso- och sjukvårdsinformatik, SIS/TK 334

Internationell titel: Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2017)

Artikelnummer: STD-8030062

Utgåva: 2

Fastställd: 2017-12-13

Antal sidor: 96

Ersätter: SS-EN ISO 11615:2012