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Medical Devices

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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
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