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IEC 62353:2014

Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment

Edition date: 2014-09-04
In Force
Available languages: English, French, Spanish
Summary: IEC 62353:2014 applies to testing of medical electrical equipment and medical electrical systems, hereafter referred to as ME equipment and ME systems, or parts of such equipment or systems, which comply with IEC 60601-1:1988 (second edition) and its amendments and IEC 60601-1:2005 (third edition) and its amendments, before putting into service, during maintenance, inspection, servicing and after repair or on occasion of recurrent tests to assess the safety of such ME equipment or ME systems or parts thereof. For equipment not built to IEC 60601-1 these requirements may be used taking into account the safety standards for the design and information in the instructions for use of that equipment. This standard contains tables with allowable values relating to different editions of IEC 60601-1. For the purpose of this standard, the application of measuring methods is independent of the edition according to which the ME equipment or ME system is designed. This standard contains "general requirements", which contain clauses of general concern, and "particular requirements", further clauses handling special types of ME equipment or ME systems and applying in connection with the "General requirements". This standard is not suitable to assess whether ME equipment or ME systems or any other equipment comply with the relevant standards for their design. This standard is not applicable to the assembly of ME systems. For assembling ME systems see Clause 16 of IEC 60601-1:2005 + IEC 60601-1:2005/AMD1:2012. This standard does not define requirements for repair, exchange of components and modification of ME equipment or ME systems. All maintenance, inspection, servicing, and repair done in accordance with the manufacturer's instructions maintain the conformity to the standard used for the design of the equipment. Otherwise conformity to applicable requirements should be assessed and verified, before the tests of this standard are performed. This standard is also applicable to tests after repair. This second edition cancels and replaces the first edition of IEC 62353 published in 2007. This edition constitutes a technical revision including the following main revisions:
- clarification in 5.3.4.1 that measurements of leakage currents based on test configurations derived from IEC 60601-1 are an allowable alternative method and the inclusion of informative explanation in Annex A;
- revision of the protective earth resistance requirements for ME systems using multiple socket outlets to take account of IEC 60601-1:2005/AMD1:2012 on the safe allowed values of protective earth resistance of plugged-in equipment;
- the inclusion of expected minimum insulation resistance values in Table 2; and
- a reordering of the sequence of testing in Annex B.

L'IEC 62353:2014 s'applique aux essais des appareils électromédicaux et des systèmes électromédicaux, ci-après dénommés appareils EM et systèmes EM, ou des parties de ces appareils ou systèmes, conformes à l'IEC 60601-1:1988 (deuxième édition) et à ses amendements et à l'IEC 60601-1:2005 (troisième édition) et à ses amendements, avant leur mise en service, pendant la maintenance, l'inspection, l'entretien courant et après leur réparation ou à l'occasion d'essais récurrents afin d'évaluer la sécurité de ces appareils EM ou systèmes EM ou de leurs parties. Pour les appareils non construits conformément à l'IEC 60601-1, ces exigences peuvent être utilisées en tenant compte des normes de sécurité pour la conception et les informations contenues dans les instructions d'utilisation de ces appareils. La présente norme comprend des tableaux donnant des valeurs admissibles se rapportant aux différentes éditions de l'IEC 60601-1. Pour les besoins de la présente norme, l'application des méthodes de mesure est indépendante de l'édition selon laquelle les appareils EM ou les systèmes EM sont conçus. La présente norme comprend des "exigences générales", contenant des articles de portée générale, et des "exigences particulières", d'autres articles traitant de types spéciaux d'appareils EM ou de systèmes EM et s'appliquant en conjonction avec les "exigences générales". La présente norme n'est pas appropriée pour évaluer si des appareils EM ou des systèmes EM ou d'autres appareils satisfont ou non aux normes correspondantes relatives à leur conception. La présente norme ne s'applique pas à l'assemblage des systèmes EM. Pour l'assemblage des systèmes EM, voir l'Article 16 de l'IEC 60601-1:2005 + IEC 60601-1:2005/AMD1:2012. La présente norme ne définit pas d'exigence pour la réparation, l'échange des composants et la modification des appareils EM ou des systèmes EM. Toutes les opérations de maintenance, inspection, entretien courant et réparation effectuées conformément aux instructions du fabricant conservent la conformité à la norme utilisée pour la conception de l'appareil. Sinon, il convient d'évaluer et de vérifier la conformité aux exigences applicables avant d'effectuer les essais de la présente norme. La présente norme s'applique également aux essais après réparation. Cette deuxième édition annule et remplace la première édition de l'IEC 62353 parue en 2007. Cette édition constitue une révision technique qui contient les principales modifications suivantes:
- clarification en 5.3.4.1 que les mesurages des courants de fuite sur la base des configurations d'essai dérivées de l'IEC 60601-1 représentent une autre méthode acceptable, et ajout d'explications informatives en Annexe A;
- révision des exigences relatives à la résistance de terre de protection pour les systèmes EM utilisant des socles de prises multiples, de façon à prendre en compte l'IEC 60601-1 Amendement 1 concernant les valeurs admises sûres de la résistance de terre de protection des appareils branchés;
- ajout des valeurs minimales attendues de la résistance d'isolement dans le Tableau 2;
- et nouvel ordre pour la séquence des essais en Annexe B. La version française de cette norme n'a pas été soumise au vote.
ICS: 11.040.01-Medical equipment in general
CTN: TC 62/SC 62A - 1359

Standards Cancellations

Anula a IEC 62353:2007

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Acuerdo de Frankfurt FprEN 62353:2014

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