Complied Standards - smartheart 01-508 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 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 environ-
ment
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: Par-
ticular requirements for the basic safety and essential performance of automated
non-invasive sphygmomanometers ISO 81060-2:2013 Non-invasive sphygmo-
manometers - Part 2: Clinical validation of automated measurement type
Software life-cycle processes
IEC 62304:2006+A1:2015 Medical device software - Software life cycle
processes
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