IEC 60601-1-6-ed.3.0

Podrobné informácie

Označenie: IEC 60601-1-6-ed.3.0

Dátum vydania: 27.01.2010

Stránok: 51

Krajina: Medzinárodná technická norma

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Anotácia

IEC 60601-1-6:2010 specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to basic safety and essential performance of medical electrical equipment. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e., normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use. If the usability engineering process detailed in this collateral standard has been complied with and the acceptance criteria documented in the usability validation plan have been met (see 5.9 of IEC 62366:2007), then the residual risks, as defined in ISO 14971, associated with usability of me equipment are presumed to be acceptable, unless there is objective evidence to the contrary (see 4.1.2 of IEC 62366:2007). The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards. This document cancels and replaces the second edition of IEC 60601-1-6 which has been technically revised. It was revised to align with the usability engineering process in IEC 62366. To allow for equipment manufacturers and testing organizations to make products and to equip themselves for conducting revised tests in accordance with this third edition, it is recommended by SC 62A that the content of this document not be adopted for mandatory implementation earlier than 3 years from the date of publication for equipment newly designed and not earlier than 5 years from the date of publication for equipment already in production. La CEI 60601-1-6:2010 specifie un processus destine a un fabricant pour analyser, specifier, concevoir, verifier et valider laptitude a lutilisation, ayant trait a la securite de base et aux performances essentielles des appareils electromedicaux. Ce processus dingenierie daptitude a lutilisation evalue et reduit les risques provoques par les problemes daptitude a lutilsation associes a une utilisation correcte et a des erreurs dutilisation, cest-a-dire une utilisation normale. Il peut etre utilise pour identifier mais nevalue pas et ne reduit pas les risques associes a une utilisation anormale. Si le processus dingenierie de laptitude a lutilisation detaille dans la presente norme collaterale a ete satisfait et si les criteres dacceptation documentes dans le plan de validation de laptitude a lutilisation ont ete satisfaits (voir le 5.9 de la CEI 62366:2007), les risques residuels definis dans lISO 14971 associes a laptitude a lutilisation dun appareil em sont alors presumes acceptables, sauf sil existe une preuve tangible du contraire (voir le 4.1.2 de la CEI 62366:2007). La presente norme collaterale est destinee a specifier des exigences generales qui viennent completer celles de la norme generale et a servir de base pour les normes particulieres. Ce document annule et remplace la deuxieme edition de la CEI 60601-1-6, et constitue une revision technique. La presente edition de la CEI 60601-1-6 a ete revisee pour etre mise en conformite avec le processus dingenierie de laptitude a lutilisation de la CEI 62366. De maniere a permettre aux fabricants dappareils et aux organismes dessai de realiser les produits et de sequiper afin deffectuer les essais revises conformement a cette troisieme edition, le SC 62A recommande que le contenu de ce document ne soit adopte, et que son application ne devienne obligatoire avant 3 ans apres la date de publication, pour les appareils nouvellement concus, et avant 5 ans apres la date de publication pour les appareils deja en production.