IEC EN 60601-2-68 Medical Electrical Equipment - Special Requirements for Basic Safety of Radiotherapy Equipment

Medical Device Tests

IEC EN 60601-2-68 Medical Electrical Equipment - Special Requirements for Basic Safety of Radiotherapy 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 60601-2-68 test. IEC EN 60601-2-68 applies to the essential safety and essential performance of X-ray-based image-guided radiotherapy (IGRT) equipment for use with External Beam Equipment (EBE).

IEC EN 60601-2-68 Medical Electrical Equipment - Special Requirements for Basic Safety of Radiotherapy Equipment

This particular standard covers the safety features of kilovoltage and megavoltage X-ray imaging devices for the purpose of IGRT, whose geometric relationship with the EBE is known. Covers aspects of communication and relationships between the EBE and X-ray imaging devices, whether fitted or not, but in the same radiation shielded area as the EBE and dedicated for use with the EBE only. This particular standard deals with real-time X-IGRT, online X-IGRT and offline X-IGRT equipment. It covers procedures to reduce the risk of over-reliance on X-IGRT EBE systems.

Modern radiotherapy practices use information from various imaging modalities obtained before starting treatment to plan treatment. Imaging provides information about the location of the target volume and other anatomical features so that a treatment plan can be developed that provides the optimum dose distribution that has the best chance of achieving the intended effect of the treatment while minimizing side effects.

However, difficulties arise when trying to apply radiation, as target volumes/critical structures are in constant motion in the body. For example, in respiratory parts of the body, target volumes/critical structures may change position or shape during radiation beam transmission through any fraction. Also, a course of therapy may span several days, during which the target volume/patient may shrink or enlarge or move. Therefore, the target volume/exact location of critical structures may vary between treatment planning imaging and actual delivery of therapy.

EUROLAB assists manufacturers with IEC EN 60601-2-68 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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