Certifications 

The Panther line ventilators are complied  with the most updated medical standards. As of November 2020 here are is a  list of certifications and standards:

 

  • CE mark approval until 2024 by DEKRA

  • FDA Emergency Use Authorization

  • ISO 13485:2016

  • EN 60601-1:2006/A1:2013 + A12:2014 (Ed 3.1) Medical electrical equipment – Part 1:General requirements for basic safety and essential performance

  • EN 60601-1-2:2015 (Edition 4.0) Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

  • EN 60601-1-8:2007 + A11:2017 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

  • ISO 80601-2-12:2011 Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators

  • EN 62304:2006 + A1:2015 Medical device software - Software life-cycle processes

  • IEC 60601-2-49:2011 Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment

  • EN ISO 14971:2012 Medical devices - Application of risk management to medical devices

  • EN 62366:2015 Medical devices - Application of usability engineering to medical devices

  • ISO 80601-2-55:2011 Medical electrical equipment —Part 2-55:Particular requirements for the basic safety and essential performance of respiratory gas monitors

  • ISO/CD 18562-1:2017 Biocompatibility evaluation of respiratory gas pathways in healthcare applications -- Part 1: Evaluation and testing within a risk management process

  • ISO/CD 18562-2:2017 Biocompatibility evaluation of respiratory gas pathways in healthcare applications -- Part 2: Tests for emissions of particulate matter

  • ISO/CD 18562-3:2017 Biocompatibility evaluation of respiratory gas pathways in healthcare applications -- Part 3: Tests for emissions of volatile organic compounds (VOCs)

  • ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems

  • ISO 15223-1:2016 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements

  • ISO 17664:2017 Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medicaldevices

  • ISO 10993 Biological evaluation of medical devices (replaced for respiratory devices by ISO 18652 Parts 1-3

  • EN 1041:2008 +A1:2013  Information supplied by the manufacturer of medical devices

  • EU MDD 93/42/EEC Medical Devices Directive

  • DIRECTIVE 2002/96/EC Waste electrical and electronic equipment (WEEE)

  • Directive 2012/19/EU Waste electrical and electronic equipment (WEEE)

  • Directive 2011/65/EU ROHS

  • MEDDEV 2.7.1 Rev.4: 2016 Guidelines on medical devices: evaluation of clinical data

  • MEDDEV 2.12/1 rev.8: 2013 Guidelines on a medical devices vigilance system