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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