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