IEC 60601-1-2-ed.4.1+Amd.1-CSV

Podrobné informace

Označení: IEC 60601-1-2-ed.4.1+Amd.1-CSV

Datum vydání: 01.09.2020

Stran: 216

Země: Mezinárodní technická norma

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Anotace

IEC 60601-1-2:2014+A1:2020 applies to the basic safety and essential performance of Medical Equipment (ME) equipment and ME systems in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by me equipment and me systems. This collateral standard to IEC 60601-1 specifies general requirements and tests for basic safety and essential performance with regard to electromagnetic disturbances and for electromagnetic emissions of ME equipment and ME systems. They are in addition to the requirements of the general standard IEC 60601-1 and serve as the basis for particular standards. This fourth edition cancels and replaces the third edition of IEC 60601-1-2, and constitutes a technical revision. The most significant changes with respect to the previous edition include the following modifications: - specification of immunity test levels according to the environments of intended use, categorized according to locations that are harmonized with IEC 60601-1-11: the professional healthcare facility environment, the home healthcare environment and special environments; - specification of tests and test levels to improve the safety of medical electrical equipment and medical electrical systems when portable RF communications equipment is used closer to the medical electrical equipment than was recommended based on the immunity test levels that were specified in the third edition; - specification of immunity tests and immunity test levels according to the ports of the medical electrical equipment or medical electrical system; - specification of immunity test levels based on the reasonably foreseeable maximum level of electromagnetic disturbances in the environments of intended use, resulting in some immunity test levels that are higher than in the previous edition; and - better harmonization with the risk concepts of basic safety and essential performance, including deletion of the defined term "life-supporting". This new edition includes the following main additions: - guidance for determination of immunity test levels for special environments; - guidance for adjustment of immunity test levels when special considerations of mitigations or intended use are applicable; - guidance on risk management for basic safety and essential performance with regard to electromagnetic disturbances; and - guidance on identification of immunity pass/fail criteria. LIEC 60601-1-2:2014+A1:2020 sapplique a la securite de base et aux performances essentielles des appareils Electro Medicaux (EM) et systemes EM en presence de perturbations electromagnetiques, ainsi quaux perturbations electromagnetiques emises par les appareils EM et systemes EM. La presente norme collaterale a la norme generale IEC 60601-1 a pour objet de specifier des exigences generales et des essais applicables a la securite de base et aux performances essentielles eu egard aux perturbations electromagnetiques et pour les emissions electromagnetiques des appareils EM et des systemes EM. Ils viennent en complement des exigences de la norme generale IEC 60601-1 et servent de base pour les normes particulieres. Cette quatrieme edition annule et remplace la troisieme edition de lIEC 60601-1-2, dont elle constitue une revision technique. Les modifications majeures par rapport a ledition precedente sont les suivantes: - specification des niveaux dessai dimmunite selon les environnements dutilisation prevue categorises selon les emplacements qui sont harmonises avec lIEC 60601-1-11: lenvironnement dun etablissement de soins de sante professionnel, lenvironnement de soins de sante a domicile et les environnements speciaux; - specification des essais et des niveaux dessai pour ameliorer la securite des appareils electromedicaux et des systemes electromedicaux lorsque des appareils de communication portatifs RF sont utilises plus pres des appareils electromedicaux quil na ete recommande sur la base des niveaux dessai dimmunite qui ont ete specifies dans la troisieme edition; - specification des essais dimmunite et des niveaux dessai dimmunite selon les acces des appareils electromedicaux ou des systemes electromedicaux; - specification des niveaux dessai dimmunite bases sur le niveau maximum raisonnablement previsible des perturbations electromagnetiques dans les environnements dutilisation prevue, resultant en des niveaux dessai dimmunite qui sont superieurs a ceux de ledition precedente; et - une meilleure harmonisation avec les concepts de risque de securite de base et des performances essentielles incluant la suppression du terme defini "maintien de la vie". Cette nouvelle edition inclut les ajouts majeurs suivants: - lignes directrices pour la determination des niveaux dessai dimmunite pour les environnements speciaux; - lignes directrices pour lajustement des niveaux dessai dimmunite lorsque des considerations speciales dattenuation ou dutilisation prevue sont applicables; - lignes directrices relatives a la gestion des risques pour la securite de base et les performances essentielles eu egard aux perturbations electromagnetiques; et - lignes directrices relatives a lidentification des criteres dechec/reussite a lessai dimmunite.