IEC EN 60601-2-62 Medical Electrical Equipment - Special Requirements for Basic Safety of High Intensity Therapeutic Ultrasound (HITU) Equipment

Medical Device Tests

IEC EN 60601-2-62 Medical Electrical Equipment - Special Requirements for Basic Safety of High Intensity Therapeutic Ultrasound (HITU) Equipment

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of IEC EN 60601-2-62 testing. IEC EN 60601-2-62 applies to the essential safety and essential performance of high-intensity therapeutic ultrasound equipment. This International Standard adds or replaces the clauses listed in IEC EN 60601-1 specifically for high intensity therapeutic ultrasound equipment.

IEC EN 60601-2-62 Medical Electrical Equipment - Special Requirements for Basic Safety of High Intensity Therapeutic Ultrasound (HITU) Equipment

If an article or sub-clause is specifically applicable to such equipment only or to related systems only, the title and content of that article or sub-article shall indicate so. If this is not the case, the substance or sub-clause applies to both individual equipment and systems as relevant.

This standard can also be applied to:

  • Therapeutic equipment for thrombolysis through exposure to high-intensity therapeutic ultrasound;
  • Therapeutic equipment for the treatment of occluded feeding vessels through exposure to high-intensity focused ultrasound;
  • Equipment intended for use for the relief of cancer pain due to bone metastasis.

This particular standard does not apply to:

  • Ultrasound Equipment intended to be used for Physiotherapy;
  • Ultrasound Equipment intended for use for lithotripsy;
  • Ultrasound Equipment intended to be used for special hyperthermia devices; And
  • Ultrasound Equipment intended for use for phacoemulsification.

In the absence of a corresponding clause or subclause in this particular standard, the clause or subclause of the general standard or applicable auxiliary standard, although possibly not relevant, applies without modification; Where any part of the general standard or applicable auxiliary standard, although possibly relevant, is intended not to be applied, a statement to that effect is given in this particular standard.

EUROLAB assists manufacturers with IEC EN 60601-2-62 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.

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