IEC 60601-2-27:2005
Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment

Standard No.
IEC 60601-2-27:2005
Release Date
2005
Published By
International Electrotechnical Commission (IEC)
Status
Replace By
IEC 60601-2-27:2011
Latest
IEC 60601-2-27:2011/COR1:2012
Scope
Addition: This Particular Standard specifies the particular safety requirements, including essential performance, for ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT as defined in 2.101 and hereinafter also referred to as EQUIPMENT. This standard is applicable to EQUIPMENT used in a hospital environment. If the EQUIPMENT is used outside the hospital environment, such as in ambulances and air transport, the EQUIPMENT shall comply with this standard. NOTE Additional standards apply to the EQUIPMENT covering specifically use outside the hospital environment. 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. Ecg telemetry systems, ambulatory ("Holter") monitors and other ECG recording devices are outside the scope of this Particular Standard.

IEC 60601-2-27:2005 history

  • 2012 IEC 60601-2-27:2011/COR1:2012 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment; Corrigendum 1
  • 2011 IEC 60601-2-27:2011 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
  • 2005 IEC 60601-2-27:2005 Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment
  • 1994 IEC 60601-2-27:1994 Medical electrical equipment - Part 2: Particular requirements for the safety of electrocardiographic monitoring equipment
Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment



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