Tagasi

EVS-EN ISO 11616:2017

Health informatics - Identification of medicinal products - Data elements and structures for the Unique Identification and Exchange of regulated Pharmaceutical Product Information (ISO 11616:2017)

Üldinfo
Kehtiv alates 18.12.2017
Alusdokumendid
ISO 11616:2017; EN ISO 11616:2017
Direktiivid või määrused
puuduvad
Standardi ajalugu
Staatus
Kuupäev
Tüüp
Nimetus
18.12.2017
Põhitekst
05.12.2012
Põhitekst
ISO 11616:2017 is intended to provide specific levels of information relevant to the identification of a Medicinal Product or group of Medicinal Products. It defines the data elements, structures and relationships between data elements that are required for the exchange of regulated information, in order to uniquely identify pharmaceutical products. This identification is to be applied throughout the product lifecycle to support pharmacovigilance, regulatory and other activities worldwide. In addition, ISO 11616:2017 is essential to ensure that pharmaceutical product information is assembled in a structured format with transmission between a diverse set of stakeholders for both regulatory and clinical (e.g. e-prescribing, clinical decision support) purposes. This ensures interoperability and compatibility for both the sender and the recipient. ISO 11616:2017 is not intended to be a scientific classification for pharmaceutical products. Rather, it is a formal association of particular data elements categorised in prescribed combinations and uniquely identified when levelling degrees of information are incomplete. This allows for Medicinal Products to be unequivocally identified on a global level. References to other normative IDMP and messaging standards for pharmaceutical product information are included in Clause 2, to be applied in the context of ISO 11616:2017. Medicinal products for veterinary use are out of scope of ISO 11616:2017.
*
*
*
PDF
18,48 € koos KM-ga
Paber
18,48 € koos KM-ga
Hind: 2,40 € koos KM-ga
Standardi monitooring
Teised on ostnud veel
Põhitekst

EVS-EN ISO 11615:2017

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2017)
Uusim versioon Kehtiv alates 18.12.2017
Põhitekst

CEN ISO/TS 20443:2018

Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO/TS 20443:2017)
Uusim versioon Kehtiv alates 04.06.2018
Põhitekst

CEN ISO/TS 20451:2018

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)
Uusim versioon Kehtiv alates 04.06.2018
Põhitekst

EVS-EN ISO 11238:2012

Meditsiiniinformaatika. Ravimite identifitseerimine. Andmeelemendid ja andmestruktuur aine normitud teabe üheseks identifitseerimiseks ning infovahetuseks (ISO11238:2012)
Kehtetu alates 16.08.2018