Legislation/Applicable standard

ReferenceTitle
LVS EN 45502-2-1:2005Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
LVS EN 45502-2-2:2008Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
LVS EN 60118-13:2005Electroacoustic - Hearing aids - Part 13: Electromagnetic compatibility (EMC)
LVS EN 60522:2003Determination of the permanent filtration of X-ray tube assemblies
LVS EN 60580:2002Medical electrical equipment - Dose area product meters
LVS EN 60601-1-10:2008Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
LVS EN 60601-1-1:2002Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
LVS EN 60601-1:1990 +A1:1993, +A2:1995, +A13:1996Medical electrical equipment - Part 1: General requirements for safety
LVS EN 60601-1:2007Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
LVS EN 60601-1-2:2003Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
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