Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

Clause 1 of the general standard3 applies, except as follows:

201.1.1 Scope

Replacement:

This part of IEC 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT (RASE) and ROBOTICALLY ASSISTED SURGICAL SYSTEMS (RASS), hereafter referred to as ME EQUIPMENT and ME SYSTEMS together with their INTERACTION CONDITIONS and INTERFACE CONDITIONS. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

If RASE or RASS, or its ACCESSORIES fall within scope of another particular standard, then the particular standard applies in addition to this standard.

EXAMPLES IEC 60601-2-2[3] for HF SURGICAL EQUIPMENT; IEC 60601-2-18[4] for ENDOSCOPIC EQUIPMENT; IEC 60601-2-22[5] for laser equipment; IEC 60601-2-37[6] for ultrasound equipment; IEC 60601-2-46[7] for operating tables, etc.

201.1.2 Object

Replacement:

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for ROBOTICALLY ASSISTED SURGICAL EQUIPMENT and ROBOTICALLY ASSISTED SURGICAL SYST