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EVS-EN 60601-2-25:2015

Elektrilised meditsiiniseadmed. Osa 2-25: Erinõuded elektrokardiograafide esmasele ohutusele ja olulistele toimimisnäitajatele

Üldinfo
Kehtiv alates 04.11.2015
Alusdokumendid
EN 60601-2-25:2015; IEC 60601-2-25:2011
Tegevusala (ICS grupid)
11.040.50 Radiograafiaseadmed
Direktiivid või määrused
puuduvad
Standardi ajalugu
Staatus
Kuupäev
Tüüp
Nimetus
04.11.2015
Põhitekst
15.12.2003
Põhitekst
01.12.2001
Põhitekst
IEC 60601-2-25:2011 applies to the basic safety and essential performance of electrocardiographs intended by themselves or as a part of a medical electrical system, for the production of electrocardiogram reports for diagnostic purposes. The equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician's office, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply to Medical electrical equipment for those environments of use. Not included within the scope of this particular standard are: a) the part of Medical electrical equipment that provides vectorcardiographic loops; b) ambulatory electrocardiographic medical electrical equipment covered by IEC 60601-2-47 where not intended for obtaining electrocardiogram reports for diagnostic purposes; c) cardiac monitors covered by IEC 60601-2-27 where not intended for obtaining electrocardiographic reports for diagnostic purposes. This second edition cancels and replaces the first edition of IEC 60601-2-25, published in 1993 and the first edition of IEC 60601-2-51, published in 2003. Updating the particular standards to refer to the third edition of the general standard provided the opportunity to merge the first editions of IEC 60601-2-25 and IEC 60601-2-51 into one standard. Reformatting and technical changes were both made. This second edition of IEC 60601-2-25 constitutes a technical revision of both those standards.
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EVS-EN 60601-2-27:2014

Elektrilised meditsiiniseadmed. Osa 2-27: Erinõuded elektrokardiograafiliste seireseadmete esmasele ohutusele ja olulistele toimimisnäitajatele
Uusim versioon Kehtiv alates 03.09.2014
Põhitekst

EVS-EN 60601-2-47:2015

Elektrilised meditsiiniseadmed. Osa 2-47: Erinõuded ambulatoorsete elektrokardiograafiasüsteemide esmasele ohutusele ja olulistele toimimisnäitajatele
Uusim versioon Kehtiv alates 08.06.2015
Põhitekst

EVS-EN 62366-1:2015

Meditsiiniseadmed. Osa 1: Kasutatavusprojekteerimise rakendamine meditsiiniseadmetele
Uusim versioon Kehtiv alates 07.05.2015
Muudatus

EVS-EN 62304:2006/A1:2015

Meditsiiniseadmete tarkvara. Tarkvara elutsükli protsessid
Kehtiv alates 04.11.2015