FAQ details

Are all safety standards complied with?

This product bears the CE seal and therefore meets the requirements of German and European safety standards applicable to the product.

Norm Kommentar
VO (EU) 2017/745 European Medical Device Regulation (MDR)
MPDG Medical Devices Implementation Act
DIN EN ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes
DIN EN ISO 9001 Quality management systems
DIN EN ISO 14001 Environmental management systems
IEC 60601-2-52 Medical electrical equipment – Particular requirements for basic safety
IEC 60601-1 Medical electrical equipment – General requirements for basic safety
IEC 60601-1-2 Medical electrical equipment – General requirements for basic safety –
Collateral standard: Electromagnetic disturbances
IEC 60601-1-6 Medical electrical equipment – General requirements for basic safety and essential performance –
Collateral standard: Usability
DIN EN ISO 14971 Application of risk management to medical devices
IEC 62366 Medical devices – Application of usability engineering to medical devices
DIN EN ISO 20417 Medical devices – Information to be supplied by the manufacturer
DIN EN ISO 15223-1 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied –
Generel requirements
DIN EN 12182 Assistive products for persons with disability
DIN EN 12530/
DIN EN 12531
Castors and wheels – Hospital bed castors
DIN 33402-1 Ergonomics – Body dimensions of people
DIN 68861-1 Furniture surfaces – Behaviour at chemical influence

 

Last update on 15. March 2022 by Florian Schmelz.

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