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IEC 80601-2-77-ed.1.1+Amd.1-CSV

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

STANDARD published on 15.11.2023

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The information about the standard:

Designation standards: IEC 80601-2-77-ed.1.1+Amd.1-CSV
Publication date standards: 15.11.2023
The number of pages: 230
Approximate weight : 721 g (1.59 lbs)
Country: International technical standard
Category: Technical standards IEC

Annotation of standard text IEC 80601-2-77-ed.1.1+Amd.1-CSV :

IEC 80601-2-77:2019+AMD1.2023 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 INTERACTION CONDITIONS and INTERFACE CONDITIONS. LIEC 80601-2-77:2019+AMD1.2023 sapplique a la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS CHIRURGICAUX ROBOTIQUEMENT ASSISTES (RASE) et des SYSTEMES CHIRURGICAUX ROBOTIQUEMENT ASSISTES (RASS), appeles APPAREILS EM et SYSTEMES EM, ainsi qua leurs CONDITIONS D’INTERACTION et leurs CONDITIONS D’INTERFACE.