IEC 60601-2-27 Electrocardiographic Monitoring Equipment Testing
Medical electrical equipment – Part 2-27: the basic safety and essential performance of electrocardiographic monitoring equipment
IEC 60601-2-27 Scope:
IEC 60601 2 27 and EN 60601 2 27 testing applies to basic safety and essential performance of electrocardiographic (ECG) monitoring equipment as defined in 201.3.63 and hereinafter also referred to as medical electronic equipment. IEC 60601-2-27 testing applies to medical electronic equipment used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport.
EN 60601-2-27 tests also apply to ECG telemetry systems used in a hospital environment. medical electronic equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment, such as in ambulances and air transport, shall comply with IEC 60601-2-27. Additional standards may apply to medical electronic equipment for those environments of use.
EN 60601-2-27 testing 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.
Keystone Compliance assists manufacturers with IEC 60601-2-27 and EN 60601-2-27 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-2-27 test lab needs.