Contact Information
Authorized European Representative:
Company:
MDSS - Medical Device Safety Service GmbH
Address:
Schiffgraben 41, 30175 Hannover, Germany
Athorized Component
Please use the Airon
authorized adaptor
Complied European Standards List
Risk management
Labeling
User manual
General
Requirements for
Safety
Electromagnetic
compatibility
Performance
requirements
Clinical investigation
Usability
Software life-cycle
processes
ISO/EN 14971:2012 Medical devices — Application of risk
management to medical devices
ISO/EN 15223-1:2012 Medical devices. Symbols to be
used with medical device labels, labelling and information to
be supplied. General requirements
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: 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 noninvasive
sphygmomanometers
IEC/EN 60601-1-2:2007 Medical electrical equipment -
Part 1-2: General requirements for basic safety and essential
performance - Collateral standard:Electromagnetic
compatibility - Requirements and tests
EN 1060-1:1995+A2:2009 Non-invasive blood pressure
Part 1: General requirements
EN 1060-3:1997+A2:2009 Non-invasive blood pressure
Part 3: Supplementary requirements for electromechanical
blood pressure measuring system
EN 1060-4: 2004 Automatic Blood Pressure Monitor
overall system 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 Standard: Usability
IEC/EN 62366: 2007 Medical devices - Application of
usability engineering to medical devices
IEC/EN 62304:2006+AC: 2008 Medical device software
- Software life cycle processes
ATHORIZED COMPONENT
COMPLIED EUROPEAN
STANDARDS LIST
26
27
100-240V 50-60Hz,400mA
6V 1A
Adaptor
Input:
Output:
AIRON AGENTURER AS
Øvre Slottsgate 18 - 20
0157 Oslo
NORWAY
Tel: +47 22 41 08 00
www.airon.no
