BS EN 60601-2-27:2014 - Medical electrical equipment. Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

BS EN 60601-2-27:2014

Medical electrical equipment. Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

Status : Current, Work in hand   Published : September 2014

Format
PDF

Format
HARDCOPY



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.




Standard NumberBS EN 60601-2-27:2014
TitleMedical electrical equipment. Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
StatusCurrent, Work in hand
Publication Date30 September 2014
Normative References(Required to achieve compliance to this standard)EN 60601-1-8:2007, IEC 60601-1-8:2006, EN 60601-2-49, EN 60601-1-2:2007, EN 60601-1-8:2007/CORR:2010, EN 60601-2-2:2009, IEC 60601-2-2:2009, IEC 60601-2-49:2011, EN 60601-2-25, IEC 60601-2-25:2011, EN 60601-1-2:2007/CORR:2010, IEC 60601-1-2:2007, EN 60601-2-2:2009/A11:2011
Informative References(Provided for Information)93/42/EEC, ANSI/AAMI EC13:2002
ReplacesBS EN 60601-2-27:2006
International RelationshipsEN 60601-2-27:2014,IEC 60601-2-27:2011,IEC 60601-2-27:2011/COR1:2012
Draft Superseded By09/30169314 DC
DescriptorsMarking, Patient monitors, Test equipment, Measuring instruments, Electrocardiographs, Medical equipment, Safety measures, Cardiology, Safety engineering, Electronic equipment and components, Instructions for use, Clinical investigation instruments, Electrical medical equipment, Testing conditions, Leakage paths, Graphic symbols, Electrical equipment, Performance testing, Monitors, Electrical safety, Accuracy, Leakage currents, Equipment safety, Circuits
ICS11.040.50
11.040.55
Title in FrenchAppareils électromédicaux. Exigences particulières pour la sécurité de base et les performances essentielles des appareils de surveillance d’électrocardiographie
Title in GermanMedizinische elektrische Geräte. Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Elektrokardiographie-Überwachungsgeräten
CommitteeCH/62/4
ISBN978 0 580 59724 4
PublisherBSI
FormatA4
DeliveryYes
Pages78
File Size2.121 MB
Price£274.00


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