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