Medical and Beauty Devices

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CELAB performs tests on medical and beauty devices relative to the CE marking.
The CEI EN 60601 standard is the reference about the electric safety of the electromedical equipments.
The tests that we can perform include the tests of:
  • EN 60601-1:Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
                EN 60601-1-2: Electromagnetic compatibility
                EN 60601-1-6: Usability
                EN 60601-1-8: Alarm Systems
                EN 60601-1-10: Requirements for the development of physiologic closed-loop controllers
                EN 60601-1-11: Requirements for medical electrical equipment and medical electrical systems used in the healthcare home environment
  • EN 60601-2-X:Medical electrical equipment – Part 2: Particular requirements for the basic safety and essential performance
Including all the standards of the series:
  • EN ISO 14971: Application of risk management to medical devices
  • MDD 93/42/EEC: Medical Device Directive

 

 

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