Complied Standards - smartheart 01-542 Manual De Instrucciones

COMPLIED STANDARDS

Risk Management
ISO 14971:2007 Medical devices — Application of risk management to
medical devices
Labeling
ISO 15223-1:2016 Medical devices. Symbols to be used with medical de-
vice labels, labeling and information to be supplied. General requirements
User manual
EN 1041: 2008 Medical equipment manufacturers to provide information
General Requirements for Safety
IEC 60601-1: 2005+A1:2012 Medical electrical equipment - Part 1:
General requirements for basic safety and essential performance
IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: Gen-
eral requirements for basic safety and essential performance - collateral
standard: requirements for medical electrical systems used in the home
healthcare environment
Electromagnetic compatibility
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance - Collateral stan-
dard: Electromagnetic compatibility - Requirements and tests
Performance and clinical requirements
IEC 80601-2-30:2009+A1:2013 Medical electrical equipment- Part 2-30:
Particular requirements for the basic safety and essential performance of
automated non-invasive sphygmomanometers ISO 81060-2:2013 Non-in-
vasive sphygmomanometers - Part 2: Clinical validation of automated
measurement type
Software life-cycle processes
IEC 62304:2006+A1:2015 Medical device software - Software life cycle
processes
ENGLISH • 33