What is BS EN IEC 80601‑2‑78 about?
BS EN IEC 80601 discusses medical electrical equipment. BS EN IEC 80601‑2‑78 outlines general requirements for basic safety and essential performance of medical robots that physically interact with a patient with an impairment to support or perform rehabilitation, assessment, or compensation. Or alleviation related to the patient’s movement functions, as intended by the manufacturer.
Note: BS EN IEC 80601‑2‑78 does not apply to external limb prosthetic devices (use ISO 22523), electric wheelchairs (use ISO 7176 (all parts)), diagnostic imaging equipment (e.g., MRI, use IEC 60601-2-33), and personal care ROBOTS (use ISO 13482).
Who is BS EN IEC 80601‑2‑78 for?
BS EN IEC 80601‑2‑78 on medical robots is useful for:
- Manufacturer of medical robots
- Test centres for medical robots
- healthcare regulatory authorities
Why should you use BS EN IEC 80601‑2‑78?
BS EN IEC 80601‑2‑78 was created when the technical evolution of medical robots was in rapid progress. A medical robot intended to be used as ME equipment or ME system consists of movement function of one or more sensory, neuromusculoskeletal, or movement-related body functions that comprise patient motor control.
BS EN IEC 80601‑2‑78 discusses an acceptable degree of basic safety, essential performance, and protection against electrical hazards, mechanical hazards, unwanted and excessive radiation hazards, and excessive temperatures and other hazards. This minimizes hazards to the patient and operator for medical robots that physically interact with a patient. The requirements are followed by specifications for the relevant tests.
