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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 [New]

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 5840-1/A1

Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements - Amendment 1 (ISO 5840-1:2021/DAM 1:2024); German and English version EN ISO 5840-1:2021/prA1:2024
Edition 2024-03

Technical Specification [CURRENT]

DIN CEN ISO/TS 20443 ; DIN SPEC 13263:2018-11

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 11980

Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2012); German version EN ISO 11980:2012
Edition 2013-03

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

Standards [CURRENT]

DIN 58959-20

Quality management in medical microbiology - Part 20: Requirements for the use of control material for the examination of protozoae and microorganisms of higher order
Edition 1997-06

Standards [CURRENT]

DIN EN ISO 11979-7

Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia (ISO 11979-7:2024); German version EN ISO 11979-7:2024
Edition 2024-06

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