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ANSI/AAMI/IEC 80601-2-77:2020
Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
Applies to the basic safety and essential performance of robotically assisted surgical equipment (RASE) and robotically assisted surgical systems (RASS), referred to as ME equipment and ME systems together with their interface conditions. This particular standard does not apply to X-ray-based image-guided radiotherapy equipment. Hazards inherent in the intended physiological function of ME equipment within the scope of this standard are not covered by specific requirements in this standard.
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Association for the Advancement of Medical Instrumentation [aami]
Association for the Advancement of Medical Instrumentation [aami]