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Standards [CURRENT]

SN EN 1641

Dentistry - Medical devices for dentistry - Materials
Edition 2010-03

Standards [CURRENT]

SN EN ISO 10993-18

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
Edition 2020-11

Technical rule [CURRENT]

VDI 5700 Blatt 1

Reprocessing hazards - Risk management in reprocessing of medical devices - Measures for risk control
Edition 2022-01

Standards [CURRENT]

SN EN ISO 14155

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
Edition 2020-10

Standards [CURRENT]

OENORM EN ISO 10993-18

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
Edition 2021-02-15

Standards [CURRENT]

SN EN ISO 16571

Systems for evacuation of plume generated by medical devices (ISO 16571:2024)
Edition 2024-04

Standards [CURRENT]

SN EN ISO 10993-9

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
Edition 2021-10

Standards [CURRENT]

SN EN ISO 10993-18/A1

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Determination of the uncertainty factor (ISO 10993-18:2020/Amd 1:2022); Amendment A1
Edition 2023-07

Standards [CURRENT]

SN EN ISO 12417-1

Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2024)
Edition 2024-03

Spezielle Regeln für die Akkreditierung im Bereich Medizinprodukte "Materialien tierischen Ursprungs"
Edition 2013-10-16

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