Terraillon Tensio Instruction Manual page 75

COMPLIED EUROPEAN STANDARDS LIST
Complied European Standards List
ISO/EN 14971:2012 Medical devices — Application of risk management
Risk management
to medical devices
Labeling EN 980 Symbols for use in the labelling of medical devices
User manual EN 1041: 2008 Medical equipment manufacturers to provide information
EN 60601-1: 2006 Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance IEC/EN 60601-1-11:
General
2010 Medical electrical equipment -- Part 1-11: General requirements for
Requirements
basic safety and essential performance - Collateral standard: Requirements
for Safety
for medical electrical equipment and medical electrical systems used in the
home healthcare environment
IEC/EN 60601-1-2:2007 Medical electrical equipment - Part 1-2: General
Electromagnetic
requirements for basic safety and essential performance - Collateral
compatibility
standard:Electromagnetic compatibility - Requirements and tests
EN 1060-1:1995+A2:2009 Non-invasive blood pressure Part 1: General
requirements
Performance
EN 1060-3:1997+A2:2009 Non-invasive blood pressure Part 3:
requirements
Supplementary requirements
for electromechanical blood pressure measuring system
Clinical EN 1060-4: 2004 Automatic Blood Pressure Monitor overall system
investigation Interventional accuracy of the testing process
IEC/EN 60601-1-6: 2010 Medical electrical equipment -- Part 1-6: General
requirements for basic safety and essential performance - Collateral
Usability
Standard: Usability IEC/EN 62366: 2007 Medical devices - Application of
usability engineering to medical devices
Software life-cycle IEC/EN 62304:2006+AC: 2008 Medical device software - Software life cycle
processes processes
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