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CEI EN 60601-1

Medical electrical equipment Part 1: General requirements for basic safety and essential performance

active, Most Current
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Organization: CEI
Publication Date: 1 September 2014
Status: active
Page Count: 280
ICS Code (Medical equipment): 11.040
scope:

The IEC 60601 series does not apply to: 

in vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT, which is covered by the IEC 61010 series [61];

implantable parts of active implantable medical devices covered by the ISO 14708 series [69]; or 

medical gas pipeline systems covered by ISO 7396-1 [68].

NOTE 2 ISO 7396-1 applies the requirement of IEC 60601-1-8 to certain monitoring and ALARM SIGNALS.

(*) N.d.R.: Per l'elenco delle Pubblicazioni si veda l'Allegato ZA.

Document History

August 1, 2015
Medical electrical equipment Part 1: General requirements for basic safety and essential performance
A description is not available for this item.
CEI EN 60601-1
September 1, 2014
Medical electrical equipment Part 1: General requirements for basic safety and essential performance
The IEC 60601 series does not apply to:  in vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT, which is covered by the IEC 61010 series [61]; implantable parts of...
July 1, 2014
Medical electrical equipment Part 1: General requirements for basic safety and essential performance
A description is not available for this item.
February 1, 2014
Medical electrical equipment Part 1: General requirements for basic safety and essential performance
A description is not available for this item.
March 1, 2012
Medical electrical equipment Part 1: General requirements for basic safety and essential performance
FOREWORD This document (EN 60601-1:2006/A11:2011) has been prepared by CLC/TC 62 "Electrical equipment in medical practice". The following dates are fixed: - Latest date by which this document has...
May 1, 2010
Medical electrical equipment Part 1: General requirements for basic safety and essential performance
La presente Variante recepisce il corrigendum EN 60601-1/EC:2010-03 che introduce una DOW al 2012-06-01 e cancella le frasi che non sono più valide.
May 1, 2007
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
La presente Norma si applica agli apparecchi elettromedicali e contiene le prescrizioni relative alla sicurezza fondamentale e le prestazioni essenziali. Questa nuova edizione è stata completamente...
December 1, 1998
Apparecchi elettromedicali - Parte 1: Norme generali per la sicurezza
La presente Norma si applica agli apparecchi elettromedicali e contiene le Norme generali per la sicurezza. Ad esse seguiranno le Norme particolari che via via saranno oggetto di Norme Europee in...
September 1, 1997
Apparecchi elettromedicali - Parte 1: Norme generali per la sicurezza
Variante 3 alla CEI EN 60601-1:1991-01/Ed.2 (fasc. 1445)
April 1, 1997
Apparecchi elettromedicali - Parte 1: Norme generali per la sicurezza
Variante 2 alla CEI EN 60601-1:1991-01/Ed.2 (fasc. 1445)
March 1, 1995
Apparecchi elettromedicali - Parte 1: Norme generali per la sicurezza
Errata corrige alla CEI EN 60601-1:1991-01/Ed.2 (fasc. 1445)
February 1, 1995
Apparecchi elettromedicali - Parte 1: Norme generali per la sicurezza
Errata corrige alla CEI EN 60601-1/A1:1994-04 (fasc. 2279 V)
April 1, 1994
Apparecchi elettromedicali - Parte 1: Norme generali per la sicurezza
Variante n. 1 alla CEI EN 60601-1:1991-01/Ed.2 (fasc. 1445)
January 1, 1991
Apparecchi elettromedicali. - Parte 1: Norme generali per la sicurezza
Allo scopo di allineare la normativa italiana a quella internazionale, viene emessa la presente Norma che recepisce la Norma Europea CENELEC EN 60601-1, contestuale alla Pubblicazione IEC 601-1...

References

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