HMM Diagnostics smartLAB Manual De Instrucciones página 65

Complied European Standards List
Risk Management
Labeling
User Manual
Generel Requirements for Safety
Electromagnetic Compatibility
Performance requirements
Clinical investigation
Usability
Software life-cycle processes
ISO/EN 14971:2012 Medical devices — Application of risk management
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+A1:2013 Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
EN 60601-1-11: 2010 Medical electrical equipment -- Part 1-11: General re-
quirements for basic safety and essential performance - Collateral standard:
Requirements for medical electrical equipment and medical electrical sys-
tems used in the home healthcare environment
EN 60601-1-2:2007 Medical electrical equipment Part 1-2: General require-
ments for basic safety and essential performance - Collateral
standard:Electromagnetic compatibility - Requirements and tests
EN ISO 81060-1:2012(new) Non-invasive
sphygmomanometers - Part 1: Requirements and test methods for non-
automated measurement type (ISO 81060-1:2007)
EN 1060-3:1997+A2:2009 Non-invasive blood pressure Part 3: Supplemen-
tary requirements for electromechanical blood pressure measuring system
EN 1060-4: 2004 Automatic Blood Pressure Monitor overall system Inter-
ventional accuracy of the testing process
EN 60601-1-6: 2010 Medical electrical equipment -- Part 1-6: General re-
quirements for basic safety and essential performance - Collateral Stan-
dard: Usability
EN 62366: 2007 Medical devices - Application of usability engineering to
medical devices
EN 62304:2006/AC: 2008 Medical device software -
Software life cycle processes
65