DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
DIN EN IEC 80601-2-77
; VDE 0750-2-77:2024-09
Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment (IEC 80601-2-77:2019 + AMD1:2023); German version EN IEC 80601-2-77:2021 + A1:2023
Medizinische elektrische Geräte - Teil 2-77: Besondere Festlegungen an die Sicherheit, einschließlich der wesentlichen Leistungsmerkmale von durch Roboter unterstützte Chirurgiegeräte (IEC 80601-2-77:2019 + AMD1:2023); Deutsche Fassung EN IEC 80601-2-77:2021 + A1:2023
Overview
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), together with their interaction conditions and interface conditions. If the RASE or RASS or its accessories fall within the scope of other particular specifications, then the particular specifications apply in addition to this standard. The standard differs from DIN EN IEC 80601-2-77 (VDE 0750-2-77):2022-10 as follows: a) updating and supplementing terms and references; b) adapting the requirements for essential performance characteristics; c) Annex NA Relationship with European and international documents; d) subclause 201.4.3 Additions to the requirements for essential performance characteristics; e) subclause 201.7.2.2 Additions for marking and inscriptions, as well as for 201.7.9.2.2 Warning and safety instructions; f) subclause 201.7.8.1 Additions for colors of signal lamps; g) subclause 201.8.5 to subclause 201.8.6 Additions for patient connection separation, isolation, and protective grounding; h) subclause 201.9 Revision of risk control measures in several clauses; i) subclause 201.11 Additions in several clauses for protection against hazards; j) Clause 202 Additions for electromagnetic disturbances. 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) together with their interaction conditions and interface conditions. The minimum safety requirements specified in these particular requirements for robotically assisted surgical equipment are assumed to ensure that residual risks are reduced to acceptable levels, unless there is objective evidence to the contrary.
