
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
NORMA vydaná dňa 20.8.2012
Designation standards: IEC 60601-1-ed.3.1+Amd.1-CSV
Publication date standards: 20.8.2012
The number of pages: 803
Approximate weight : 2440 g (5.38 lbs)
Country: International technical standard
Kategória: Technické normy IEC
IEC 60601-1:2005+A1:2012 contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Where particular standards exist, this standard should not be used alone. This consolidated version consists of the third edition (2005) and its amendment 1 (2012). Therefore, there is no need to order the amendment in addition to this publication. This document includes the contents of the corrigenda 1 (2006), 2 (2007) and 3 (2022), the contents of the corrigendum to Amendment 1 (2014), as well as the interpretation sheets 1 (2008), 2 (2009), 3 (2013) and interpretation sheet to amendment 1 (2021). IEC TR 62348:2012 provides a tool to assist users of IEC 60601-1:2005 to assess the impact of the most significant changes in Amendment 1:2012, and to trace requirements between the third edition and the amended second edition. LIEC 60601-1:2005+A1:2012 contient les exigences concernant la securite de base et les performances essentielles qui sont generalement applicables aux appareils electromedicaux. Pour certains types dappareil electromedicaux, ces exigences sont soit completees soit modifiees par des exigences specifiques donnees dans une norme collaterale ou une norme particuliere. Lorsquil existe une norme particuliere, il est recommande de ne pas utiliser la presente norme generale seule. Cette version consolidee comprend la troisieme edition (2005) et son amendement 1 (2012). Il nest donc pas necessaire de commander lamendement avec cette publication. Ce document inclut le contenu des corrigenda 1 (2006), 2 (2007) et 3 (2022), le contenu du corrigendum a lAmendement 1 (2014), ainsi que les feuilles dinterpretation 1 (2008), 2 (2009), 3 (2013) et de la feuille dinterpretation de lamendement 1 (2021).