VSI CLAROX plus - Safety Standards

V X - 100 User Manual(v01 )
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3.3 Safety Standards
IEC 60601-
1:2005+CORR.1:2006+CORR.2:2007+A1:2012
EN 60601-1:2006+A1:2013
Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance
IEC 60601-1-2:2014
EN 60601-1-2:2015
Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential
performance – Collateral Standard: Electromagnetic
disturbances - Requirements and tests
IEC 60601-1-3:2008+A1:2013
EN 60601-1-3:2010
Medical electrical equipment - Part 1-3: General
requirements for basic safety and essential
performance - Collateral Standard: Radiation
protection in diagnostic X-ray equipment
IEC 60601-1-6:2010+A1:2013
EN 60601-1-6:2010
Medical electrical equipment – Part 1-6: General
requirements for safety – Collateral standard :
usability
IEC 60601-2-28:2017
Medical electrical equipment - Part 2-28: Particular
requirements for the basic safety and essential
performance of X-ray tube assemblies for medical
diagnosis
IEC 60601-2-54:2009+A1:2015
Medical electrical equipment - Part 2-54: Particular
requirements for the basic safety and essential
performance of X-ray equipment for radiography and
radioscopy
IEC 62304:2008
EN 62304:2006+AC:2008
Medical device – Software life cycle
IEC 62366:2007+A1:2014
EN 62366:2008
Medical devices - Application of usability engineering
to medical devices