DIN EN 60601-2-19:2017
Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators (IEC 60601-2-19:2009 + Cor.:2012 + A1:2016); German version EN 60601-2-19:2009 + A11:2011 + A1:2016

Standard No.

DIN EN 60601-2-19:2017

Release Date

2017

Published By

German Institute for Standardization

Latest

DIN EN 60601-2-19:2017

Replace

DIN EN 60601-2-19:2010 DIN EN 60601-2-19/A1:2015

Scope

This particular standard specifies safety requirements for infant incubators but alternate methods of compliance with a specific clause by demonstrating equivalent safety will not be judged as non-compliant if the manufacturer has demonstrated in his risk management file that the risk presented by the hazard has been found to be of an acceptable level when weighed against the benefit of treatment from the device.

DIN EN 60601-2-19:2017 Referenced Document

• DIN EN 60601-1-10:2016 Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers (IEC 60601-1-10:2007 + A1:2013); German version EN ...
• DIN EN 60601-1-11:2016 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 6060
• DIN EN 60601-1-12:2016 Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical service
• DIN EN 60601-1-1:2002 Medical electrical equipment - Part 1-1: General requirements for safety; Collateral standard: Safety requirements for medical electrical systems (IEC 60601-1-1:2000); German version EN 60601-1-1:2001
• DIN EN 60601-1-2:2016 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests (IEC 60601-1-2:2014); German version EN 60601-1-2:2015
• DIN EN 60601-1-3:2014 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment (IEC 60601-1-3:2008 + A1:2013); German version EN 60601-1-3:2008 + Cor.:2010
• DIN EN 60601-1-4:2001 Medical electrical equipment - Part 1-4: General requirements for safety; Collateral standard: Programmable electrical medical systems (IEC 60601-1-4:1996 + A1:1999); German version EN 60601-1-4:1996 + A1:1999
• DIN EN 60601-1-6:2016 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010 + A1:2013); German version EN 60601-1-6:2010 + A1:2015
• DIN EN 60601-1-8:2014 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (IEC
• DIN EN 60601-1-9:2014 Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design (IEC 60601-1-9:2007 + A1:2013); German version EN 60601-1-9:2008 + A1:2013
• DIN EN 60601-1:2013 Medical electrical equipment.Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 + Cor. :2006 + Cor. :2007 + A1:2012); German version EN 60601-1:2006 + Cor. :2010 + A1:2013
• DIN EN 60601-2-1 Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV (IEC 60601-2-1:2009 + A1:2014); German version EN 60601-2-1:2015
• DIN EN 60601-2-10:2015 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators (IEC 60601-2-10:2012); German version EN 60601-2-10:2015
• DIN EN 60601-2-1:2016 Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV (IEC 60601-2-1:2009 + A1:2014); German version EN 60601-2-1:2015
• DIN EN 60601-2-2:2010 Medical electrical equipment - Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (IEC 60601-2-2:2009); German version EN 60601-2-2:2009
• DIN EN 60601-2-3:2016 Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment (IEC 60601-2-3:2012); German version EN 60601-2-3:2015
• DIN EN 60601-2-4:2012 Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators (IEC 60601-2-4:2010); German version EN 60601-2-4:2011
• DIN EN 60601-2-5:2016 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment (IEC 60601-2-5:2009); German version EN 60601-2-5:2015
• DIN EN 60601-2-6:2016 Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment (IEC 60601-2-6:2012); German version EN 60601-2-6:2015
• DIN EN 60601-2-8:2016 Medical electrical equipment - Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV (IEC 60601-2-8:2010 + A1:2015); German version EN 60601-2-8:2015 + A1:2016

DIN EN 60601-2-19:2017 history

• 2017 DIN EN 60601-2-19:2017 Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators (IEC 60601-2-19:2009 + Cor.:2012 + A1:2016); German version EN 60601-2-19:2009 + A11:2011 + A1:2016
• 2010 DIN EN 60601-2-19:2010 Medical electrical equipment - Part 2-19: Particular requirements for basic safety and essential performance of infant incubators (IEC 60601-2-19:2009); German version EN 60601-2-19:2009
• 0000 DIN EN 60601-2-19:2007
• 0000 DIN EN 60601-2-19:1998