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Standards [CURRENT]

DIN EN 62359

Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields (IEC 62359:2010 + Cor.:2011 + A1:2017); German version EN 62359:2011 + A1:2018
Edition 2018-09

Draft standard [Pre-order]

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

Draft standard [New]

DIN EN ISO 10993-7

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO/DIS 10993-7:2024); German and English version prEN ISO 10993-7:2024
Edition 2024-08

Technical rule [CURRENT]

VDI 5703 Blatt 1

Systematical development for a model-based testing of medical devices - Fundamentals
Edition 2021-12

Technical rule [CURRENT]

VDI 2310 Blatt 12

Maximum ambient concentrations referring to human health - Maximum ambient concentrations for nitrogen dioxide
Edition 2004-12

Technical rule [CURRENT]

VDI 5701

Biomaterials in medicine - Classification, requirements, and applications
Edition 2018-05

Publication

Risikomanagement und Biologische Sicherheit von Medizinprodukten

Am Beispiel der biologischen Bewertung und unter Einbeziehung der DIN EN ISO 10993-1 und DIN EN ISO 14971
Edition 2022-01

Publication

Aseptische Herstellung

 
Edition 2016-10

Publication

Nicht aktive Medizinprodukte

Horizontale Europäische Normen in Anlehnung an entsprechende EU-Richtlinien und -Verordnungen
Edition 2022-06

Publication

Klinische Prüfung von Medizinprodukten

Kommentar zu DIN EN ISO 14155
Edition 2024-01

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