IEC 60601-1:2005
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1:2005 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. The contents of the corrigenda of December 2006, December 2007 and December 2022, the interpretation sheets of April 2008, January 2009 and May 2013 have been included in this copy.
IEC 60601-1:2005 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. The contents of the corrigenda of December 2006, December 2007 and December 2022, the interpretation sheets of April 2008, January 2009 and May 2013 have been included in this copy.
This is the major revised and updated baseline of standards for the safety of all medical electrical equipment used by or under the supervision of qualified personnel in the general medical and patient environment. lt also contains certain requirements for reliable operation to ensure safety. Note the change of title from the first (1977) edition. (For particular requirements see series 601-2 below.)
The mainstay of safety standards in all the rapidly evolving technology of electromedical equipment, the second (1988) edition of IEC 601-1 called for updating through this first Amendment.
COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.
Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!
Request your free, no-obligation live demo
I discover COBAZ