GOST R ISO 18113-1-2015 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 1. Terms, definitions and general requirements
IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
ISO 1000:1992 SI units and recommendations for the use of their multiples and of certain other units
ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 14971:2007 Medical devices - Application of risk management to medical devices
ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
GOST R ISO 18113-1-2015 history
2015GOST R ISO 18113-1-2015 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 1. Terms, definitions and general requirements