easytech T CaRe Compact User Manual page 5


EN ISO 14971:
Medical devices - Application of risk management to medical devices

EN ISO 10993-1 :
Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk
management process

EN ISO 15223-1
Medical Devices - Symbols to be used with medical devices labels, labelling and
information to be supplied – Part 1: General Requirements

EN 1041
Information supplied by the manufacturer of medical devices

ISO 13485
Medical devices – Quality management systems – Requirements for regulatory
purposes
Easytech s.r.l. – User Manual T CaRe Compact rev. D Pag. 5 di 36