BS EN 60601-2-27:2006 - Medical electrical equipment. Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment – BSI British Standards

BS EN 60601-2-27:2006

Medical electrical equipment. Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment

Status : Superseded, Withdrawn   Published : May 2006 Replaced By : BS EN 60601-2-27:2014,

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BS EN 60601-2-27:2006 Medical electrical equipment. Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment

BS EN 60601-2-27 concerns the safety of electrocardiographic monitoring equipment. It introduces general guidance and rationale for the essential performance of equipment such as defibrillator protection, performance requirements and alarming.

Contents include:

  • protection against electric shock hazards
  • separation
  • dielectric strength
  • protection against mechanical hazards
  • protection against hazards from unwanted or excessive radiation
  • electromagnetic compatibility
  • protection against hazards of ignition of flammable anaesthetic mixtures
  • protection against excessive temperatures and other safety hazards
  • overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection
  • interruption of the power supply
  • accuracy of operating data
  • protection against hazardous output
  • abnormal and fault conditions
  • environmental tests
  • constructional requirements
  • components and general assembly

BS EN 60601-2-27:2006 supersedes BS EN 6061-2-27:1995 which has been withdrawn.




Standard NumberBS EN 60601-2-27:2006
TitleMedical electrical equipment. Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment
StatusSuperseded, Withdrawn
Publication Date31 May 2006
Withdrawn Date17 July 2018
Normative References(Required to achieve compliance to this standard)EN 60529:1991, EN 60601-1:1990, IEC 60601-2-2:1998, IEC 60601-1:1988, EN 60601-1-4:1996, IEC 60529:1989, EN 60601-1:1990/Corrigendum:1994, IEC 60601-1:1988/AMD 2:1995, EN 60601-1-1:2001, EN 60601-1-2:2001, IEC 60601-1-1:2000, EN 60601-1:1990/AMD 2:1995, IEC 60601-1:1988/AMD 1:1991, IEC 60601-1-4:1996/AMD 1: 1999, EN 60529:1991/Corrigendum:1993, IEC 60601-1-2:2001, EN 60601-2-2:2000, EN 60601-1:1990/AMD 13:1996, EN 60601-1:1990/AMD 1:1993, IEC 60601-1:1988/Corrigendum:1995, IEC 60601-1-4:1996/AMD 1:1999, IEC 60601-1-4:1996, EN 60601-1-4:1996/AMD 1:1999
Informative References(Provided for Information)93/42/EEC
ReplacesBS EN 60601-2-27:1995, BS 5724-2.127:1995,IEC 60601-2-27:1994
International RelationshipsEN 60601-2-27 Corr 1 (12/06)
Amended ByCorrigendum, December 2007
DescriptorsLeakage paths, Marking, Safety engineering, Leakage currents, Electrocardiographs, Graphic symbols, Electrical equipment, Electrical medical equipment, Circuits, Accuracy, Medical equipment, Patient monitors, Equipment safety, Electronic equipment and components, Measuring instruments, Test equipment, Performance testing, Instructions for use, Cardiology, Clinical investigation instruments, Monitors, Testing conditions, Electrical safety, Safety measures
ICS11.040.50
Title in FrenchAppareils electromedicaux. Exigences particulieres de securite, incluant les performances essentielles, des appareils de surveillance d'electrocardiographie
Title in GermanMedizinische elektrische Geraete. Besondere Festlegungen fuer die Sicherheit einschliesslich der wesentlichen Leistungsmerkmale von Elektrokardiographie-Ueberwachungsgeraeten
CommitteeCH/62/4
ISBN978 0 580 60888 9
PublisherBSI
FormatA4
DeliveryYes
Pages74
File Size1.027 MB
Price£274.00


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