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IEC 80601-2-26:2019+AMD1:2024 CSV

Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs

Edition date: 2024-02-14
In Force
Available languages: English, French
Summary: 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 s'applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des ELECTROENCEPHALOGRAPHES définis en 201.3.204, aussi appelés APPAREILS EM ou SYSTEMES EM dans la présente norme. Le présent document est applicable aux ELECTROENCEPHALOGRAPHES destinés à être utilisés dans les établissements de soins professionnels, l'ENVIRONNEMENT DES SERVICES MEDICAUX D'URGENCE ou l'ENVIRONNEMENT DES SOINS A DOMICILE.
Les exigences propres à d'autres appareils également utilisés en électroencéphalographie ne relèvent pas du domaine d'application du présent document, par exemple:
- stimulateurs phonophotiques;
- appareils de stockage et restitution d'informations d'EEG;
- APPAREILS EM destinés particulièrement à la surveillance au cours d'une thérapie électro-convulsive.
Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux APPAREILS EM ou uniquement aux SYSTEMES EM, le titre ou le contenu de cet article ou de ce paragraphe l'indique. Si ce n'est pas le cas, l'article ou le paragraphe s'applique à la fois aux APPAREILS EM et aux SYSTEMES EM, comme suit.
L'article ou le paragraphe s'applique aux APPAREILS EM, par défaut. Pour les APPAREILS EM dont la mesure ou la fonction de sécurité correspondante n'est pas complètement intégrée dans l'APPAREIL EM, mais plutôt mise en œuvre dans un SYSTEME EM, le FABRICANT de l'APPAREIL EM spécifie dans les DOCUMENTS D'ACCOMPAGNEMENT les exigences de fonctionnalité et de sécurité qu'assure le SYSTEME EM pour être conforme au présent document. Le SYSTEME EM est vérifié en conséquence.
Les DANGERS inhérents à la fonction physiologique prévue des APPAREILS EM ou des SYSTEMES EM dans le cadre du domaine d'application du présent document ne sont pas couverts par des exigences spécifiques contenues dans le présent document.
Cette édition constitue une révision technique destinée à s'aligner sur l'Amendement 1:2012 de l'IEC 60601-1:2005 et sur les nouvelles versions des normes collatérales et leurs amendements.
ICS: 11.040.01-Medical equipment in general
CTN: TC 62/SC 62D - 1365

Correcciones Normas

Es corregida por IEC 80601-2-26:2019/COR1:2021

Modificaciones Normas

Es modificada por IEC 80601-2-26:2019/AMD1:2024

Otras Relaciones

Acuerdo de Frankfurt prEN 60601-2-26:2017

Reemplazo Normas

Reemplaza a IEC 60601-2-26:2012

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