IEC 60601-1-11-ed.2.1+Amd.1-CSV

Detail information

Designation: IEC 60601-1-11-ed.2.1+Amd.1-CSV

Publication date: 22/07/2020

Pages: 257

Country: International technical standard

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Anotation

IEC 60601-1-11:2015+A1:2020 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment. It applies regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. The home healthcare environment includes: - the dwelling place in which a patient lives; - other places where patients are present both indoors and outdoors, excluding professional healthcare facility environments where operators with medical training are continually available when patients are present. This second edition cancels and replaces the first edition of IEC 60601-1-11, published in 2010, and constitutes a technical revision. The most significant changes with respect to the previous edition include the following modifications: - correction of test method for relative humidity control at temperatures above 35 °C; - redrafting of subclauses that altered instead of adding to the general standard or other collateral standards; and - harmonizing with the changes to the amendments to the general standard and other collateral standards. This consolidated version consists of the second edition (2015) and its amendment 1 (2020). Therefore, no need to order amendment in addition to this publication. IEC 60601-1-11:2015+A1:2020 sapplique a la securite de base et aux performances essentielles des appareils electromedicaux et des systemes electromedicaux, destines a etre utilises dans lenvironnement des soins a domicile. Elle sapplique sans distinguer si lappareil electromedical ou le systeme electromedicalest prevu pour etre utilise par un operateur non specialiste ou par du personnel de sante qualifie. Lenvironnement des soins a domicile comprend: - lhabitation dans laquelle un patient vit; - dautres environnements ou des patients sont presents a linterieur comme a lexterieur, a lexclusion des environnements des etablissements de soins ou des operateurs ayant une formation medicale sont disponibles de facon continue lorsque des patients sont presents. Cette deuxieme edition annule et remplace la premiere edition de lIEC 60601-1-11, parue en 2010. Cette edition constitue une revision technique. Les modifications majeures par rapport a ledition precedente sont les suivantes: - correction de la methode dessai pour le controle de lhumidite relative a des temperatures superieures a 35 °C; - reformulation des paragraphes qui modifient plus quils ne completent la norme generale ou dautres normes collaterales; et - harmonisation avec les modifications apportees aux amendements de la norme generale et aux autres normes collaterales. Cette version consolidee comprend la deuxieme edition (2015) et son amendement 1 (2020). Il nest donc pas necessaire de commander lamendement avec cette publication.