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Quality Policy

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The TLV-TRATO Group has shown its commitment to continuous improvement by implementing a quality management system.

This system is mainly based on the following standards :

  • ISO 9001 : Quality management systems
  • ISO 13485 : Medical devices — Quality management systems — Regulatory requirements
  • Compliance with Directive 93/42/EEC “Medical devices”
    • EN ISO 11197 :Medical supply units
    • EN ISO 7396-1 : Medical gas pipeline systems – Part 1: Pipelines for compressed medical gases and vacuum
    • EN 60601-1 : Medical electrical equipment Part 1: General requirements for basic safety and essential performance
    • EN 60601-1-2 :Medical electrical equipment Part 1-2: General safety requirements – Collateral Standard: Electromagnetic compatibility – Requirements and tests
    • EN ISO 14971 :Applying risk management to medical devices
    • CE Marking for Medical Devices
  • Compliance with Directive 2006/95/EC “Low Voltage”
    • EN 60598-1 : EN 60598-1: Luminaires – Part 1: general requirements and tests
  • Compliance with Directive 2004/108/EC on “Electromagnetic Compatibility”
  • Functional testing, ground continuity, dielectric strength, insulation resistance and leakage current