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Standards [CURRENT]

DIN EN 1640

Dentistry - Medical devices for dentistry - Equipment; German version EN 1640:2009
Edition 2010-02

Standards [CURRENT]

DIN EN 1639

Dentistry - Medical devices for dentistry - Instruments; German version EN 1639:2009
Edition 2010-02

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

Draft standard [New]

DIN EN ISO 10993-23/A1

Biological evaluation of medical devices - Part 23: Tests for irritation - Amendment 1: Additional in vitro reconstructed human epidermis models (ISO 10993-23:2021/DAM 1:2024); German and English version EN ISO 10993-23:2021/prA1:2024
Edition 2024-10

Standards [CURRENT]

DIN EN 1641

Dentistry - Medical devices for dentistry - Materials; German version EN 1641:2009
Edition 2010-02

Draft standard [New]

DIN EN ISO 10993-17/A1

Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents - Amendment 1 (ISO 10993-17:2023/DAM 1:2024); German and English version EN ISO 10993-17:2023/prA1:2024
Edition 2024-09

Standards [CURRENT]

DIN ISO 15309

Implants for surgery - Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices (ISO 15309:2013)
Edition 2021-12

Standards [CURRENT]

DIN EN ISO 10993-9

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019); German version EN ISO 10993-9:2021
Edition 2022-03

Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015 + COR1:2016 + A1:2020); German version EN 62366-1:2015 + AC:2015 + A1:2020
Edition 2021-08

Standards [CURRENT]

DIN EN ISO 9626

Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016); German version EN ISO 9626:2016
Edition 2016-12

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