Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment
This National Standard of Canada is equivalent to International Standard CEI/IEC 60601-2-27:2005. 1 Scope and object This clause of the General Standard applies except as follows: *1.1 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.