Medical electrical equipment – Part 2-86: Particular requirements for basic safety and essential performance of electrocardiographs, including diagnostic equipment, monitoring equipment, ambulatory equipment, electrodes, cables and leadwires

201.1 * Scope, object and related standards

Clause 1 of the general standard1) applies, except as follows:

201.1.1 * Scope

Replacement:

This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of ECG ME EQUIPMENT and ACCESSORIES (including ECG ELECTRODES, TRUNK CABLES, and LEAD WIRES) as defined in 201.3.9, hereinafter also referred to as ECG ME EQUIPMENT. Additional specific requirements apply to the ECG ME EQUIPMENT based on the INTENDED USE claimed by the MANUFACTURER for equipment intended for ECG PATIENT monitoring, diagnostic, or ambulatory use as defined in 201.3.20, 201.3.7 and 201.3.1 respectively. This particular standard applies to ECG ME EQUIPMENT for use in professional healthcare facilities as well as in EMERGENCY MEDICAL SERVICE ENVIRONMENTS and HOME HEALTHCARE ENVIRONMENTS.

The scope for each of these types of ECG ME EQUIPMENT are described as follows:

ECG ME EQUIPMENT

Any ELECTROCARDIOGRAPHic device or system that acquires an ECG signal from the body surface of one PATIENT and displays, records, analyzes, or transmits the resultant data for the purpose of diagnosing, treating, or monitoring that PATIENT. This includes any device or system that meets the definition of MONITORING, DIAGNOSTIC, or AMBULATORY ECG ME EQUIPMENT as well as any other device that acquires an ECG signal for the purpose of diagnosing, treating or monitoring a PATIENT based on the acquired body surface ECG signal. This does not include devices that are used for diagnosing, treating or monitoring PATIENTS based on acquisition of other types of cardiac signals such as magnetocardiographic signals or derived from other cardiac signals such as heart rate  monitors derived from a photo plethysmograph. In addition, ECG ME EQUIPMENT does not include devices that are used for health and wellness (e.g. phone based or mobile heart rate monitors and fitness devices). This does not include external defibrillators unless they have an INTENDED USE for making a diagnosis, monitoring or treatment from the ECG waveform in addition to the function of delivering a defibrillation shock based on the ECG.

DIAGNOSTIC ECG ME EQUIPMENT

Any ELECTROCARDIOGRAPHic device or system that acquires a 12 lead ECG signal for the purpose of diagnosis from the interpretation of the cardiac rhythm, conduction, and waveform contour. This includes any device that acquires diagnostic resting ECG as well as any other type of ECG ME EQUIPMENT that claims to have the capability of acquiring a diagnostic 12 lead ECG. Although derived 12 lead ECG recordings are used for diagnostic purposes, they are not considered equivalent to a diagnostic 12 lead ECG (refer to Annex AA) and are excluded from the scope of DIAGNOSTIC ECG ME EQUIPMENT. Devices which have multiple purposes and include the DIAGNOSTIC ECG ME EQUIPMENT definition in the INTENDED USE are included within this scope.

AMBULATORY ECG ME EQUIPMENT

Any ECG ME EQUIPMENT that continuously acquires and stores an ECG signal and may store measurements from an ambulatory PATIENT for the purpose of diagnosis from the interpretation of cardiac rhythm or conduction. This includes Holter systems and continuous long-term ambulatory full disclosure recording systems; Holter recorders, mobile cardiac telemetry and long-term ambulatory patch recorders are included within this scope. Non-continuous event recorders and loop recorders are excluded. Devices which have multiple purposes and include the AMBULATORY ECG ME EQUIPMENT definition in the INTENDED USE are included within this scope.

MONITORING ECG ME EQUIPMENT

Any ECG ME EQUIPMENT that acquires an ECG for the purpose of monitoring the cardiac activity of one PATIENT. This includes displaying ECG, displaying measurements such as heart rate, and generating alarms based on analysis of the ECG. This includes ECG telemetry systems used in a hospital environment, but ambulatory ("Holter") monitors and fetal heart rate monitors are outside the scope of MONITORING ECG ME EQUIPMENT. Devices which have multiple purposes and include the MONITORING ECG ME EQUIPMENT definition in the INTENDED USE are included within this scope.