smartheart 01-508EM Manual De Instrucciones página 35

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 device 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: General 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 standard: Electromagnetic compatibility -
Requirements and tests
Performance and clinical requirements
IEC 80601-2-30:2009+A1:2013 Medical electrical equipment- Part 2-30: Particular require-
ments for the basic safety and essential performance of automated non-invasive sphygmoma-
nometers ISO 81060-2:2013 Non-invasive 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
Clinical investigation:
ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2:
Clinical validation of automated measurement type
Usability:
IEC 60601-1-6:2010+A1:2013
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential
performance - Collateral standard: Usability
IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical
devices
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