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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

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 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

Standards [CURRENT]

DIN EN ISO 17523

Health informatics - Requirements for electronic prescriptions (ISO 17523:2016); German version EN ISO 17523:2016
Edition 2016-12

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

Technical Specification

DIN CEN ISO/TS 23758

Guidelines for the validation of qualitative screening methods for the detection of residues of veterinary drugs in milk and milk products (ISO/TS 23758:2021); German version CEN ISO/TS 23758:2021
Edition 2022-02

Standards [CURRENT]

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

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

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