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.
|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 –
|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 17. January 2023 by Florian Schmelz.