Malsch IMPULSE KL, Instruction Manual

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PRODUCT SAFET Y
This product bears the CE seal and therefore meets the requirements of the applicable German and European safety standards.
Standard Comment
MPDG Medical devices implementation act
Regulation (EU) 2017 / 745 Medical Device Regulation (MDR)
BS EN ISO 13485 Medical devices. Quality management systems
BS EN ISO 9001 Quality management systems
BS EN ISO 14001 Environmental management systems
BS EN ISO 14971 Risk analysis
BS EN 12182 Assistive products for persons with disability
BS EN 60601-2-52 Medical electrical equipment
BS EN 60601-1 Medical electrical equipment
BS EN 60601-1-2 EMC – electromagnetic compatibility
BS EN 12530 / BS EN 12531 Medical castors
BS EN ISO 15223-1 Symbols to be used with medical device labels
BS EN 1041 Symbols and information accompanying medical products
DIN 33402-1 Human body dimensions
DIN 68861-1 Furniture surfaces
BfArM recommendation German Federal Institute for Drugs and Medical Devices (BfArM)