Streamlining IEC 60601-1 3rd Edition Compliance

Is your CE Marking up to scratch?

When you consider the technological changes that have taken place in the last ten years, it is hardly surprising that revisions to a fundamental standard for medical devices has left many manufacturers with serious issues of non-compliance.

Although your medical product may have been originally designed to be compliant with all relevant standards and guidelines in its original form, the CE marking could now be invalid because of a thorough revision of IEC 60601-1 which replaces the previous version, IEC 60601-1:1988 and its associated amendments. IEC 60601 refers to the series of technical standards for the safety and reliability of medical electrical equipment.

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