IEC 80601-2-26-ed.1.1+Amd.1-CSV

Podrobné informace

Označení: IEC 80601-2-26-ed.1.1+Amd.1-CSV

Datum vydání: 14.02.2024

Stran: 158

Země: Mezinárodní technická norma

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Anotace

IEC 80601-2-26:2019+AMD1:2024 CSV applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROENCEPHALOGRAPHS as defined in 201.3.204, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. This document is applicable to ELECTROENCEPHALOGRAPHS intended for use in professional healthcare facilities, the EMERGENCY MEDICAL SERVICES ENVIRONMENT or the HOME HEALTHCARE ENVIRONMENT. This document does not cover requirements for other equipment used in electroencephalography such as: - phono-photic stimulators; - EEG data storage and retrieval; - ME EQUIPMENT particularly intended for monitoring during electro-convulsive therapy. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title or 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 follows. The clause or subclause applies to ME EQUIPMENT, as default. For ME EQUIPMENT with the corresponding safety measure or function not completely integrated into the ME EQUIPMENT but instead implemented in an ME SYSTEM, the ME EQUIPMENT MANUFACTURER specifies in the ACCOMPANYING DOCUMENTS which functionality and safety requirements are provided by the ME SYSTEM to comply with this document. The ME SYSTEM is verified accordingly. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document. This edition constitutes a technical revision to align with Amendment 1:2012 of IEC 60601-1:2005, new versions of collateral standards and amendments thereto. IEC 80601-2-26:2019+AMD1:2024 CSV sapplique a la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des ELECTROENCEPHALOGRAPHES definis en 201.3.204, aussi appeles APPAREILS EM ou SYSTEMES EM dans la presente norme. Le present document est applicable aux ELECTROENCEPHALOGRAPHES destines a etre utilises dans les etablissements de soins professionnels, lENVIRONNEMENT DES SERVICES MEDICAUX DURGENCE ou lENVIRONNEMENT DES SOINS A DOMICILE. Les exigences propres a dautres appareils egalement utilises en electroencephalographie ne relevent pas du domaine dapplication du present document, par exemple: - stimulateurs phonophotiques; - appareils de stockage et restitution dinformations dEEG; - APPAREILS EM destines particulierement a la surveillance au cours dune therapie electro-convulsive. Si un article ou un paragraphe est specifiquement destine a etre applicable uniquement aux APPAREILS EM ou uniquement aux SYSTEMES EM, le titre ou le contenu de cet article ou de ce paragraphe lindique. Si ce nest pas le cas, larticle ou le paragraphe sapplique a la fois aux APPAREILS EM et aux SYSTEMES EM, comme suit. Larticle ou le paragraphe sapplique aux APPAREILS EM, par defaut. Pour les APPAREILS EM dont la mesure ou la fonction de securite correspondante nest pas completement integree dans lAPPAREIL EM, mais plutot mise en ouvre dans un SYSTEME EM, le FABRICANT de lAPPAREIL EM specifie dans les DOCUMENTS DACCOMPAGNEMENT les exigences de fonctionnalite et de securite quassure le SYSTEME EM pour etre conforme au present document. Le SYSTEME EM est verifie en consequence. Les DANGERS inherents a la fonction physiologique prevue des APPAREILS EM ou des SYSTEMES EM dans le cadre du domaine dapplication du present document ne sont pas couverts par des exigences specifiques contenues dans le present document. Cette edition constitue une revision technique destinee a saligner sur lAmendement 1:2012 de lIEC 60601-1:2005 et sur les nouvelles versions des normes collaterales et leurs amendements.