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IEC 60601-1-2:2014+AMD1:2020 CSV

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

Edition date: 2020-09-01
In Force
Available languages: English, French
Summary: 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.

L'IEC 60601-1-2:2014+A1:2020 s'applique à la sécurité de base et aux performances essentielles des appareils Electro Médicaux (EM) et systèmes EM en présence de perturbations électromagnétiques, ainsi qu'aux perturbations électromagnétiques émises par les appareils EM et systèmes EM. La présente norme collatérale à la norme générale IEC 60601-1 a pour objet de spécifier des exigences générales et des essais applicables à la sécurité de base et aux performances essentielles eu égard aux perturbations électromagnétiques et pour les émissions électromagnétiques des appareils EM et des systèmes EM. Ils viennent en complément des exigences de la norme générale IEC 60601-1 et servent de base pour les normes particulières. Cette quatrième édition annule et remplace la troisième édition de l'IEC 60601-1-2, dont elle constitue une révision technique. Les modifications majeures par rapport à l'édition précédente sont les suivantes:
- spécification des niveaux d'essai d'immunité selon les environnements d'utilisation prévue catégorisés selon les emplacements qui sont harmonisés avec l'IEC 60601-1-11: l'environnement d'un établissement de soins de santé professionnel, l'environnement de soins de santé a domicile et les environnements spéciaux;
- spécification des essais et des niveaux d'essai pour améliorer la sécurité des appareils électromédicaux et des systèmes électromédicaux lorsque des appareils de communication portatifs RF sont utilisés plus près des appareils électromédicaux qu'il n'a été recommandé sur la base des niveaux d'essai d'immunité qui ont été spécifiés dans la troisième édition;
- spécification des essais d'immunité et des niveaux d'essai d'immunité selon les accès des appareils électromédicaux ou des systèmes électromédicaux;
- spécification des niveaux d'essai d'immunité basés sur le niveau maximum raisonnablement prévisible des perturbations électromagnétiques dans les environnements d'utilisation prévue, résultant en des niveaux d'essai d'immunité qui sont supérieurs à ceux de l'édition précédente; et
- une meilleure harmonisation avec les concepts de risque de sécurité de base et des performances essentielles incluant la suppression du terme défini "maintien de la vie". Cette nouvelle édition inclut les ajouts majeurs suivants:
- lignes directrices pour la détermination des niveaux d'essai d'immunité pour les environnements spéciaux;
- lignes directrices pour l'ajustement des niveaux d'essai d'immunité lorsque des considérations spéciales d'atténuation ou d'utilisation prévue sont applicables;
- lignes directrices relatives à la gestion des risques pour la sécurité de base et les performances essentielles eu égard aux perturbations électromagnétiques; et
- lignes directrices relatives à l'identification des critères d'échec/réussite à l'essai d'immunité.
ICS: 33.100.20-Immunity, 11.040.01-Medical equipment in general, 33.100.10-Emission
CTN: TC 62/SC 62A - 1359

Standards Cancellations

Anula a IEC 60601-1-2:2007

Anula a IEC 60601-1-2:2007/ISH1:2010

Modificaciones Normas

Es modificada por IEC 60601-1-2:2014/AMD1:2020

Otras Relaciones

Acuerdo de Frankfurt FprEN 60601-1-2:2013

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