top of page

Certifications 

Certifications

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

 

  • CE mark approval by DEKRA

  • Approved by FDA.

  • ISO 13485:2016

  • EN 60601-1 Part 1:General requirements for basic safety and essential performance

  • EN 60601-1-2:2015 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: 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: Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators

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

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

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

  • EN 62366: 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: Biocompatibility evaluation of respiratory gas pathways in healthcare applications -- Part 1: Evaluation and testing within a risk management process

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

  • ISO/CD 18562-3: 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: Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements

  • ISO 17664: 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

bottom of page