IEC EN 60601-2-75 Medical Electrical Equipment - Special Requirements for Photodynamic Therapy and Basic Safety of Photodynamic Diagnostic 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 60601-2-75 testing. IEC EN 60601-2-75 applies to the basic safety and basic performance of photodynamic therapy and photodynamic diagnostic equipment.

This standard applies to photodynamic therapy and photodynamic diagnostic equipment used for the compensation or alleviation of disease, injury or disability. In the case of combined equipment (e.g. equipment with an additional function or applied part for the target area), such equipment also complies with any specific standard that specifies safety requirements for the additional function.

Photodynamic therapy (PDT) is a medical treatment that involves the use of photosensitizing agents and light to destroy or selectively target abnormal cells, such as cancer cells. Photodynamic diagnosis (PDD) is a diagnostic technique that uses similar principles in which photosensitizing agents are used to improve the visualization of tissues or structures under certain lighting conditions. These treatments and diagnostic methods have applications in various medical fields, including oncology.

This particular standard does not apply to:

• Light therapy equipment intended for use in photothermal ablation, coagulation and hyperthermia;
• Low level laser therapy equipment not intended for use with a photosensitizer;
• Lighting equipment not intended for use with a photosensitizer, but intended for use in observation, monitoring and diagnosis.

In the IEC EN 60601 series, specific standards can modify or delete the requirements contained in the general standard and the assurance standards applicable to the associated ME equipment, and add other essential safety and essential performance requirements.

EUROLAB assists manufacturers with IEC EN 60601-2-75 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.