Easytech s.r.l. – User Manual T CaRe Compact
rev. D
Pag. 5 di 36
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
