![]() ![]() The second class of device is not connected directly to earth, so an increased effective protection against shock is required, to provide double insulation. For this class of device, only basic insulation is required. The first one considers that the device is earthed to protect users from a shock. However, the acceptance criteria of the immunity of the device (the maximum level of surrounding electromagnetic perturbation supported by the device) depend on a risk analysis.ĭifferent tests are conducted to prove that the emission of the device and its immunity conform to regulation.Ħ0601-1 Protection against electric shock The maximum level of emission is defined in the standard. Indeed, the effect of electromagnetic perturbation generated by the product (emission) must be verified as well as the effect of the electromagnetic perturbation generated by surrounding equipment (immunity). This electromagnetic compatibility is bidirectional. Tests reports from certified ISO 17025 test lab have to be presented to the Notified Body as part of the technical file (technical documentation). Tests must be conducted on the device to verify the compliance with the standard. Every point of the standard needs to be verified and referenced in a Compliance or Conformity Matrix. The other standards are related to the specific characteristic of all medical electrical equipment not fully addressed in the standard 60601-1, as standard 6 states for EMC and 6 for Alarms.Īn electrical medical device needs to comply with the IEC 60601-1. This standard specifies general requirements for basic safety and essential performance.Ĭollateral standards apply the 6 standard states for radiation protection in diagnostic X-ray equipment. IEC 60601: Safety and effectiveness of medical electrical equipment. ![]()
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