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IEC 60601-2-27-ed.3.0
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
STANDARD published on 30.3.2011
The information about the standard:
Designation standards: IEC 60601-2-27-ed.3.0
Publication date standards: 30.3.2011
SKU: NS-410719
The number of pages: 149
Approximate weight : 478 g (1.05 lbs)
Country: International technical standard
Category: Technical standards IEC
The category - similar standards:
Annotation of standard text IEC 60601-2-27-ed.3.0 :
IEC 60601-2-27:2011 applies to electrocardiographic monitoring equipments used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. This particular standard also applies to ECG telemetry systems used in a hospital environment. Electrocardiographic monitoring equipments intended for use under extreme or uncontrolled environmental conditions outside the hospital environment, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply for those environments of use. This standard is not applicable to electrocardiographic monitors for home use. However, manufacturers should consider using relevant clauses of this standard as appropriate for their intended use. Ambulatory ("Holter") monitors, fetal heart rate monitoring, pulse plethysmographic devices, and other ECG recording equipment are outside the scope of this particular standard. The aim of this third edition is to bring this particular standard up to date with reference to the third edition of the general standard through reformatting and technical changes. The contents of the corrigendum of May 2012 have been included in this copy. La CEI 60601-2-27:2011 sapplique aux appareils de surveillance electrocardiographique utilises dans un environnement hospitalier, ainsi quen dehors de cet environnement, tels que dans les ambulances et les moyens de transport aerien. La presente norme particuliere sapplique egalement aux systemes de telemetrie ECG utilises dans un environnement hospitalier. Les appareils de surveillance electrocardiographique concus pour etre utilises dans des conditions extremes ou dans des conditions denvironnement non controlees a lexterieur de lenvironnement hospitalier, tels que dans les ambulances ou les moyens de transport aerien, doivent etre conformes a la presente norme particuliere. Des normes supplementaires peuvent sappliquer pour ces environnements dutilisation. La presente norme ne sapplique pas aux moniteurs delectrocardiographie pour une utilisation a domicile. Il convient cependant que les fabricants envisagent dutiliser les articles correspondants de la presente Norme, en fonction de leur application a lutilisation prevue. Les moniteurs ambulatoires (dits "Holter"), la surveillance de la frequence cardiaque foetale, les dispositifs plethysmographiques de pouls et les autres appareils denregistrement dECG nentrent pas dans le domaine dapplication de la presente norme particuliere. Lobjet de la presente troisieme edition est de mettre a jour la presente norme particuliere en prenant en compte la troisieme edition de la norme generale par un reformatage et des modifications techniques. Le contenu du corrigendum de mai 2012 a ete pris en consideration dans cet exemplaire.
These corrections apply to this standard:
IEC 60601-2-27-ed.3.0/Cor.1
Correction
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Corrigendum 1 - Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
(Corrigendum 1 - Appareils electromedicaux - Partie 2-27: Exigences particulieres pour la securite de base et les performances essentielles des appareils de surveillance d´electrocardiographie)
Correction published on 16.5.2012
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