CELAB carries out tests on medical devices and for aesthetic purposes related to the CE marking.
The standard CEI EN 60601 is the normative reference for electrical safety of medical devices.
Tests which can be carried out include:
- 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 closed circuit physiological controllers
- EN 60601-1-11: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- EN 60601-2-X: Medical electrical equipment – Part 2: Special requirements for 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 Devices Directive