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English 45
Mode of operation Continuous operation
Degree of protection Type BF applied part
Protection against ingress of water IP21
Software version V01
Device classification Internally Powered ME Equipment
complied European standards list
14
Risk management
EN ISO 14971: 2012 Medical devices - Application of risk management to medical devices
(ISO14971: 2007, Corrected version 2007-10-01)
Labelling EN 980: 2008 Symbols for use in the labelling of medical devices
User manual EN 1041: 2008 Information supplied by the manufacturer of medical devices
General requirements for safety
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 requirements for basic
safety and essential performance - Collateral standard: Requirements for medical electrical
equipment and medical electrical systems used in the home healthcare environment
IEC/EN 80601-2-30: 2009 Medical electrical equipment - Part 2-30: Particular
requirements for the basic safety and essential performance of automated non-invasive
sphygmomanometers
45


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