ISO 80601-2-72:2015

Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients

Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients

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Referenced standards

ASTM F2761-09EN 13718-1:2008EN 15986:2011EN 1789:2007IEC 60038:2009IEC 60065:2001IEC 60335-1:2001IEC 60364-1:2005IEC 60364-4-41:2005IEC 60364-4-42:2010
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Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients

ISO 80601-2-72:2015 applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as me equipment:

  • intended for use in the home healthcare environment;
  • intended for use by a lay operator;
  • intended for use with patients who are dependent on mechanical ventilation for their life support.

ISO 80601-2-72:2015 is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system or to a ventilator where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator.

ISO 80601-2-72:2015 is a particular International Standard in the IEC 60601-1 and ISO/IEC 80601 series of standards.

Edition2015
Standard Part No74
Published Date2015
Published ByInternational Standardization Organisation
Page Count87