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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

Draft standard [New]

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/DIS 11615:2025); German and English version prEN ISO 11615:2025
Edition 2025-10

Draft standard [New]

DIN EN ISO 11616

Health informatics - Identification of medicinal products - Data elements and structures for unique identification and exchange of regulated pharmaceutical product information (ISO/DIS 11616:2025); German and English version prEN ISO 11616:2025
Edition 2025-11

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 14155

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/DIS 14155:2024); German and English version prEN ISO 14155:2024
Edition 2024-09

Standards [CURRENT]

DIN EN ISO 14155

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020
Edition 2021-05

Draft standard

DIN EN ISO 22532

Health informatics - Identification of medicinal products - Core vocabulary (terms and definitions) for the IDMP Standards (ISO/DIS 22532:2025); German and English version prEN ISO 22532:2025
Edition 2025-04

Standards [CURRENT]

DIN EN ISO 14155/A11

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020); German version EN ISO 14155:2020/A11:2024
Edition 2025-03

Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11615 data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO/TS 20443:2017); English version CEN ISO/TS 20443:2018
Edition 2018-11

Standards [CURRENT]

DIN EN ISO 11979-10

Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes (ISO 11979-10:2018); German version EN ISO 11979-10:2018
Edition 2018-08

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