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Standards [CURRENT]

DIN EN ISO 20417

Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12); German version EN ISO 20417:2021
Edition 2022-03

Standards [CURRENT]

DIN EN ISO 10993-5

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); German version EN ISO 10993-5:2009
Edition 2009-10

Standards [CURRENT]

DIN EN ISO 12417-1

Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2024); German version EN ISO 12417-1:2024
Edition 2024-08

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 13979

Dentistry - Cement spatulas
Edition 2009-05

Medical device software - Software life-cycle processes (IEC 62304:2006 + A1:2015); German version EN 62304:2006 + Cor.:2008 + A1:2015
Edition 2016-10

Standards [CURRENT]

DIN EN 556-2

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2024
Edition 2025-01

Standards [CURRENT]

DIN EN 556-1

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2024
Edition 2024-09

Draft standard

DIN EN ISO 20417

Medical devices - Information to be supplied by the manufacturer (ISO/DIS 20417:2024); German and English version prEN ISO 20417:2024
Edition 2024-12

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