Malsch AYLEEN CARE BED, Instruction Manual

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This product bears the CE seal and therefore meets the requirements of the applicable German and European safety standards.
Laws and standards Title
Regulation (EU) 2017 / 745 European Medical Device Regulation
MPDG Medical devices implementation act
DIN EN ISO 13485 Quality management for medical devices – Requirements for regulatory purposes
BS EN ISO 9001 Quality management systems
DIN EN ISO 14001 Environmental management systems
IEC 60601-2-52 Medical electrical equipment – Particularly requirements for safety
DIN EN 60601-1 Medical electrical equipment – General requirements for safety
DIN EN 60601-1-2 Medical electrical equipment – Electromagnetic (EM) disturbances
IEC 60601-1-6 Medical electrical equipment – Usability
DIN EN ISO 14971 Risk management for medical devices
IEC 62366 Medical devices – Application of usability engineering to medical devices
DIN EN ISO 20417 Medical devices – Requirements for the information to be supplied by the manufacturer
DIN EN ISO 15223-1 Symbols to be used for labelling medical devices
DIN EN 12182 Technical aids for disabled persons
DIN EN 12530 / DIN EN 12531 Medical castors / hospital bed castors
DIN 33402-1 Ergonomics – Body dimensions of people
DIN 68861-1 Furniture surfaces – Resistance to chemical attack
PRODUCT SAFETY