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Standards [CURRENT]

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

Standards [CURRENT]

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

Draft standard

DIN EN ISO 18113-4

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/DIS 18113-4:2021); German and English version prEN ISO 18113-4:2021
Edition 2021-09

Draft standard

DIN EN ISO 18113-3

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/DIS 18113-3:2021); German and English version prEN ISO 18113-3:2021
Edition 2021-09

Draft standard

DIN EN ISO 18113-5

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/DIS 18113-5:2021); German and English version prEN ISO 18113-5:2021
Edition 2021-09

Standards [CURRENT]

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

Draft standard

DIN EN ISO 18113-2

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO/DIS 18113-2:2021); German and English version prEN ISO 18113-2:2021
Edition 2021-09

Standards [CURRENT]

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

Technical Specification

DIN CEN ISO/TS 16791

Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers (ISO/TS 16791:2020); German version CEN ISO/TS 16791:2020
Edition 2021-02

Standards [CURRENT]

DIN EN ISO 20184-2

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins (ISO 20184-2:2018); German version EN ISO 20184-2:2018
Edition 2019-06

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