Medical electrical equipment safety

IEC 60601 is a series of technical standards that ensure the safety of medical electrical equipment. Public health authorities in many countries recognise the standard as a prerequisite for the commercialisation of electrical medical equipment, so its requirements must be met in different markets around the globe.

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It is relevant to manufacturers of medical electrical equipment and systems, and those that manufacture components of medical electrical equipment.

The standard series includes, but is not limited to, requirements regarding electrical hazards, mechanical hazards, the spread of fire from the equipment, as well as laser sources and sonic and ultrasonic pressure. It is also applicable for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes.

This standard adds further product-specific requirements for IVD medical equipment to the general standard, such as biohazards and hazardous chemical substances.

The rapid technological changes in medical equipment have necessitated prompt revisions to safety standards...


Read the full article in DPA's December 2024 issue


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