scope:

This clause of the General Standard applies except as follows: 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. 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. The object of this Particular Standard is to specify particular requirements for the safety, including essential performance, of EQUIPMENT as defined in 2.101. This Particular Standard refers to IEC 60601-1:1988, Medical electrical equipment - Part 1: General requirements for safety as amended by its Amendment 1 (1991) and Amendment 2 (1995). The General Standard takes into account IEC 60601-1-1:2000, Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems, IEC 60601-1-2:2001, Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests and IEC 60601-1-4:1996, Medical electrical equipment - Part 1: General requirements for safety - 4. Collateral standard: Programmable electric medical systems and its Amendment 1 (1999). For brevity, Part 1 is referred to in this Particular Standard either as the "General Standard" or as the "General Requirement(s)", and IEC 60601-1-1, IEC 60601-1-2 and IEC 60601-1-4 as the "Collateral Standards".