domain
Medical Devices
(9 standards)Industries: Medical Devices
CE MarkingActive
CE Marking
Conformité Européenne — European Conformity
European UnionEuropean Economic Area
ISO 13485:2016Active
ISO 13485:2016
Medical devices — Quality management systems — Requirements for regulatory purposes
Global
ISO 14971:2019Active
ISO 14971:2019
Medical devices — Application of risk management to medical devices
Global
IEC 60601-1 Ed.3.2 (2020)Active
IEC 60601-1 Ed.3.2 (2020)
Medical electrical equipment — Part 1: General requirements for basic safety and essential performance
Global
IEC 62366-1:2015+AMD1:2020Active
IEC 62366-1:2015+AMD1:2020
Medical devices — Part 1: Application of usability engineering to medical devices
Global
RoHS 3 (2011/65/EU)Active
RoHS 3 (2011/65/EU)
Restriction of Hazardous Substances in Electrical and Electronic Equipment
European UnionEuropean Economic Area
UKCA MarkingActive
UKCA Marking
UK Conformity Assessed — United Kingdom Product Compliance
United Kingdom
EU MDR 2017/745Active
EU MDR 2017/745
European Medical Devices Regulation — Regulation (EU) 2017/745
European UnionEuropean Economic Area
FDA 510(k)Active
FDA 510(k)
Premarket Notification — US Medical Device Clearance Program
United States