ISO 80601-2-77:2019

Medical electrical equipment-- Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
Autor: ISO
Código ICS: 11.040.01
Vigente
$322.490

Alcance

Replacement:This part of IEC 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE ofROBOTICALLY ASSISTED SURGICAL EQUIPMENT (RASE) and ROBOTICALLY ASSISTED SURGICALSYSTEMS (RASS), hereafter referred to as ME EQUIPMENT and ME SYSTEMS together with theirINTERACTION CONDITIONS and INTERFACE CONDITIONS. If a clause or subclause is specificallyintended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content ofthat clause or subclause will say so. If that is not the case, the clause or subclause appliesboth to ME EQUIPMENT and to ME SYSTEMS, as relevant.If RASE or RASS, or its ACCESSORIES fall within scope of another particular standard, then theparticular 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] foroperating tables, etc.

Especificaciones de la Norma
Fecha de Publicación 11/07/2019
Título Secundario Appareils électromédicaux-- Partie 2-77: Exigences particulières pour la sécurité de base et les performances essentielles des appareils chirurgicaux robotiquement assistés
Páginas Técnicas 96
Idioma Inglés