Users Manual Part 2

21
Harmonised Standards
EN 60601-1:2006/A1:2013
Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance
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
EN ISO 14971:2012
Medical devices - Application of risk management to medical
devices
EN 61000-3-3:2013
Electromagnetic compatibility (EMC) - Part 3-3: Limits -
Limitation of voltage changes, voltage fluctuations and flicker
in public low-voltage supply systems, for equipment with rated
current <= 16 A per phase and not subject to conditional
connection
EN 50581:2012
Technical documentation for the assessment of electrical and
electronic products with respect to the restriction of hazardous