What is BS EN 60601-2-27 - Safety and performance of electrocardiographic monitoring equipment about?
BS EN 60601 is a European standard that discusses medical electrical equipment. BS EN 60601-2-27 provides basic safety and essential performance of electrocardiographic (ECG) monitoring equipment to ensure the practical degree of safety in the operation of endoscopic equipment.
BS EN 60601-2-27 is the twenty-seventh subpart of the second part of a multi-part series that applies to ME equipment used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport.
BS EN 60601-2-27 also applies to ECG telemetry systems used in a hospital environment.
ME EQUIPMENT intended for use under extreme or uncontrolled environmental conditions outside the hospital environment, such as in ambulances and air transport, shall comply with BS EN 60601-2-27. Additional standards may apply to ME EQUIPMENT for those environments of use.
Note 1: BS EN 60601-2-27 does not apply to electrocardiographic monitors for home use. however, manufacturers should consider using relevant clauses of this standard as appropriate for their intended use.
Note 2: Ambulatory ("Holter") monitors, fetal heart rate monitoring, pulse plethysmographic devices, and other ECG recording equipment are outside the scope of BS EN 60601-2-27.
Who is BS EN 60601-2-27 - Safety and performance of electrocardiographic monitoring equipment for?
BS EN 60601-2-27 on Safety and performance of electrocardiographic monitoring equipment is useful for:
- Manufacturers of electrocardiographic monitoring equipment
- Operators and technical staff for electrocardiographic monitoring equipment
- Medical test laboratories
- Regulatory authorities
Why should you use BS EN 60601-2-27 - Safety and performance of electrocardiographic monitoring equipment?
Electrocardiographic (ECG) monitoring medical electrical equipment device including electrodes, lead wires, and interconnecting means for the monitoring and/or recording of heart action potentials from one patient and displaying the resultant data.
BS EN 60601-2-27 guideline assists you with the general requirements for testing of medical electrical equipment, protection against electrical hazards, protection against mechanical hazards, protection against unwanted, protection against excessive radiation hazards, protection against excessive temperatures, and other hazards for basic safety and essential performance of electrocardiographic monitoring equipment.
BS EN 60601-2-27 also guides on the accuracy of controls, protection against hazardous outputs, hazardous situations, fault conditions, programmable electrical medical systems, and electromagnetic compatibility for electrocardiographic monitoring equipment.
With obedience and compliance to BS EN 60601-2-27, you can enhance the efficacy and standardise the performance of electrocardiographic monitoring equipment. In addition, ensures the health and safety of patients and operators.
