IEC 62366-1-ed.1.1+Amd.1-CSV

Detail information

Designation: IEC 62366-1-ed.1.1+Amd.1-CSV

Publication date: 17/06/2020

Pages: 246

Country: International technical standard

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Anotation

IEC 62366-1:2015+A1:2020 specifies a process for a manufacturer to analyse, specify, develop and evaluate the usability of a medical device as it relates to safety. This usability engineering (human factors engineering) process permits the manufacturer to assess and mitigate risks 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. This first edition of IEC 62366-1, together with the first edition of IEC 62366-2 (not published yet), cancels and replaces the first edition of IEC 62366 published in 2007 and its Amendment 1:2014. Part 1 has been updated to include contemporary concepts of usability engineering, while also streamlining the process. It strengthens links to ISO 14971:2007 and the related methods of risk management as applied to safety related aspects of medical device user interfaces. Part 2, once published, will contain tutorial information to assist manufactures in complying with Part 1, as well as offering more detailed descriptions of usability engineering methods that can be applied more generally to medical devices that go beyond safety-related aspects of medical device user interfaces. The contents of the corrigendum of July 2016 have been included in this copy. This consolidated version consists of the first edition (2015) and its amendment 1 (2020). Therefore, no need to order amendment in addition to this publication. LIEC 62366-1:2015+A1:2020 specifie un processus permettant a un fabricant danalyser, de specifier, de developper et devaluer laptitude a lutilisation dun dispositif medical, concernant la securite. Ce processus dingenierie de laptitude a lutilisation (ingenierie des facteurs humains) permet au fabricant devaluer et de reduire les risques associes a une utilisation correcte et a des erreurs dutilisation, cest-a-dire une utilisation normale. Il peut etre utilise pour identifier les risques associes a une utilisation anormale mais ne les evalue pas et ne les reduit pas. La premiere edition de lIEC 62366-1, ainsi que la premiere edition de lIEC 62366-2 (a paraitre), annulent et remplacent la premiere edition de lIEC 62366 parue en 2007 et son Amendement 1:2014. La Partie 1 a ete mise a jour afin dinclure des concepts contemporains dingenierie de laptitude a lutilisation, tout en rationalisant le processus. Elle renforce aussi les liens avec lISO 14971:2007 et les methodes connexes de gestion des risques appliquees aux aspects relatifs a la securite des interfaces utilisateur des dispositifs medicaux. A sa parution, la Partie 2 contiendra des informations didactiques pour aider les fabricants a se conformer a la Partie 1 et fournira des descriptions plus detaillees des methodes dingenierie de laptitude a lutilisation qui peuvent etre appliquees dune facon plus generale aux dispositifs medicaux et qui vont au-dela des aspects relatifs a la securite des interfaces utilisateur des dispositifs medicaux. Le contenu du corrigendum de juillet 2016 a ete pris en consideration dans cet exemplaire. Cette version consolidee comprend la premiere edition (2015) et son amendement 1 (2020). Il nest donc pas necessaire de commander lamendement avec cette publication.