STN EN ISO 11616
Označenie: | STN EN ISO 11616 |
Platnosť: | Platná |
Počet strán: | 46 |
Jazyk: |
EN
|
Listinná verzia: | 18,90€ |
Elektronická verzia: |
a) Bez možnosti tlače, prenosu textu a obrázkov:
17,01€ b) Bez možnosti tlače, s prenosom textu a obrázkov: 18,90€ c) S možnosťou tlače, prenosu textu a obrázkov: 24,57€ |
Slovenský názov: | Zdravotnícka informatika. Identifikácia liekov. Dátové prvky a štruktúry na jednoznačnú identifikáciu a výmenu informácií o regulovanom farmaceutickom výrobku (ISO 11616: 2017) |
Anglický názov: | Health informatics - Identification of medicinal products - Data elements and structures for the Unique Identification and Exchange of regulated Pharmaceutical Product Information (ISO 11616:2017) |
Dátum vydania: | 01. 06. 2018 |
Dátum zrušenia: | |
ICS: | 35.240.80 |
Triediaci znak: | 84 8114 |
Úroveň zapracovania: | idt EN ISO 11616:2017, idt ISO 11616:2017 |
Vestník: | 05/18 |
Zmeny: | |
Nahradzujúce normy: | |
Nahradené normy: | STN EN ISO 11616:2013-04 (84 8114) |
Poznámka vo Vestníku: | |
Predmet normy: | This document 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, this document 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. ... |