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ISO 11615:2017

Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information
19. 10. 2017.

Опште информације

90.92     29. 11. 2023.

ISO

ISO/TC 215

Međunarodni standard

35.240.80  

engleski   francuski  

Kupovina

Objavljen

Jezik na kome želite da primite dokument.

Apstrakt

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.

Životni ciklus

PRETHODNO

POVUČEN
ISO 11615:2012

TRENUTNO

OBJAVLJEN
ISO 11615:2017
90.92 Odluka o izmeni ili reviziji standarda
29. 11. 2023.

ISPRAVKE / IZMENE

OBJAVLJEN
ISO 11615:2017/Amd 1:2022

REVIDIRAN OD

PROJEKAT
ISO/DIS 11615

Nacionalna preuzimanja

SRPS EN ISO 11615:2018  
ISS

Informatika u zdravstvu – Identifikacija medicinskih proizvoda – Elementi i strukture podataka za jedinstvenu identifikaciju i razmenu regulisanih informacija o medicinskim proizvodima

60.60   Standard objavljen

I215 Saznaj više