Mediana A16M-DF-0E, Руководство оператора

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MEDIANA
HEART ON
AED A16
Automated External Defibrillator
55
55
Compliance
Item Standard Description
Classification IEC 60601-1:2005+A1:2012
EN 60601-1:2006 A1:2013 Internally powered (on battery power)
Type of
protection IEC 60601-1:2005+A1:2012
EN 60601-1:2006 A1:2013 Type CF
–
Applied part
Mode of
operation IEC 60601-1:2005+A1:2012
EN 60601-1:2006 A1:2013 Continuous
Degree of
protection IEC 60529:1989+A1:1999 +A2:2013
EN 60529:1991+A1:2000 +A2:2013 IP55 (provided by enclosures)
General ISO 13485:2003/Cor 1:2009
EN ISO 13485:2012/AC:2012 Quality systems - Medical devices -
Requirements for regulating purposes
ISO 14971:2007
EN ISO 14971:2012 Application of risk management to Medical
devices
IEC 62304:2006+A1:2015
EN 62304:2006/AC:2008 Medical device software - Software life-cycle
processes
IEC 60601-1-6:2010 +A1:2013
EN 60601-1-6:2010 Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential
performance - Collateral standard: Usability
IEC 62366-1:2015
EN 62366-1:2015 Medical devices - Application of usability
engineering to Medical devices
IEC60601-1-11:2015 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
Ambulance EN 1789:2007 +A2:2014 Medical vehicles and their equipment
–
road ambulance
Defibrillator IEC 60601-2-4:2010
EN 60601-2-4:2011 Medical electrical equipment - Part 2-4: Particular
requirements for the basic safety and essential
performance of cardiac defibrillators
EMC
IEC 60601-1-2:2014
EN 60601-1-2:2015 Electromagnetic compatibility-requirements & test
Package ISTA (Procedure 2A, 2001) Pre-Shipment test procedures (Package)
Battery IEC 60086-4:2014 Primary batteries – Part 4: Safety of lithium
batteries