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UNE-EN ISO 27953-1
Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 1: Framework for adverse event reporting (ISO 27953-1:2011) (Endorsed by AENOR in January of 2012.)
Edition
2012-01-01
UNE-EN ISO 27953-2
Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 2: Human pharmaceutical reporting requirements for ICSR (ISO 27953-2:2011) (Endorsed by AENOR in January of 2012.)
Edition
2012-01-01
DIN EN ISO 27953-2
Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 2: Human pharmaceutical reporting requirements for ICSR (ISO 27953-2:2011); German and English version EN ISO 27953-2:2011, only on CD-ROM
Edition
2012-09
DIN EN ISO 27953-1
Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 1: Framework for adverse event reporting (ISO 27953-1:2011); German and English version EN ISO 27953-1:2011, only on CD-ROM
Edition
2012-09
DIN EN ISO 11616
Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information (ISO 11616:2017); German version EN ISO 11616:2017
Edition
2018-04
DIN EN ISO 11240
Health informatics - Identification of medicinal products - Data elements and structures for unique identification and exchange of units of measurement (ISO 11240:2012); German version EN ISO 11240:2012
Edition
2013-03
DIN EN ISO 11615
Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO 11615:2017 + Amd 1:2022); German version EN ISO 11615:2017 + A1:2022
Edition
2022-12
DIN ISO 13022
Medical products containing viable human cells - Application of risk management and requirements for processing practices (ISO 13022:2012)
Edition
2014-06
DIN EN ISO 11238
Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances (ISO 11238:2018); German version EN ISO 11238:2018
Edition
2018-11
DIN EN ISO 11239
Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging (ISO 11239:2023); German version EN ISO 11239:2023
Edition
2023-10