List Of Complied European Standards - Soehnle SYSTO MONITOR CONNECT 400 Instrucciones De Manejo

Risk management
Labeling
User manual
General Require-
ments for Safety
Electromagnetic
compatibility
Performance
requirements
Clinical investi-
gation
Usability
Software life-cycle
processes

LIST OF COMPLIED EUROPEAN STANDARDS

EN ISO 14971:2012 Medical devices - Application of risk manage-
ment to medical devices
EN 980:2008 Symbols for use in the labelling of medical devices
EN 1041:2008 Information supplied by the manufacturer of medical
devices
EN 60601-1:2006 Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
EN 60601-1-11:2015 Medical electrical equipment - Part 1-11:
General requirements for basic safety and essential performance -
Collateral standard: Requirements for medical electrical equipment
and medical electrical systems used in the home healthcare
environment
EN 60601-1-2:2007 Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance - Collateral
standard: Electromagnetic compatibility - Requirements and tests
EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1:
Requirements and test methods for non-automated measurement
type
EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers -
Part 3: Supplementary requirements for electro-mechanical blood
pressure measuring systems
EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test
procedures to determine the overall system accuracy of automated
non-invasive sphygmomanometers
EN 60601-1-6:2010 Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential performance - Collateral
standard: Usability
EN 62366:2008 Medical devices - Application of usability engineering
to medical devices
EN 62304:2006/AC: 2008 Medical device software - Software
life-cycle processes
EN
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