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 201.3.211, 201.3.240, and 201.3.222, 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 201.3.226, 201.3.207 and 201.3.202 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. In addition, clauses may be applied to ACCESSORIES (including ECG ELECTRODES, TRUNK CABLES, and LEAD WIRES) or a part or parts of an ECG system (e.g. AMBULATORY ECG RECORDER).
The scope for each of these types of ECG ME EQUIPMENT are described as follows:
ECG ME EQUIPMENT Any ECG device or system or part of a system, including ECG ELECTRODEs, TRUNK CABLEs, and LEAD WIREs and interconnecting means, that acquires an ECG signal from the body surface of one PATIENT and/or displays, records, analyses, or transmits the resultant data for the purpose of diagnosing, treating, or monitoring that PATIENT. This includes any device or system or part of a system that meets the definition of MONITORING, DIAGNOSTIC, or AMBULATORY ECG ME EQUIPMENT as well as any other device that acquires and/or processes 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 only on 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 or phonocardiograph. In addition, ECG ME EQUIPMENT does not include devices that are solely used for health and wellness (e.g. fitness trackers measuring heart rate solely to improve general wellness or athletic performance). However, devices that are part of consumer devices (such as watches, patches, body-worn devices and similar devices) that acquired an ECG and displays, records, analyses, and/or transmits the ECG for the purpose of diagnosing, treating or monitoring the PATIENT are included in the scope of an ECG ME EQUIPMENT. 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.
This does not include direct fetal ECG equipment and Fetal & Maternal MONITORING EQUIPMENT
Note: Fetal & Maternal Monitor: A Fetal-Maternal monitor that non-invasively measures and displays Fetal heart rate (FHR), Maternal heart rate (MHR) and uterine activity (UA). The equipment acquires and displays the FHR & MHR tracing from abdominal surface ELECTRODES that pick up the Fetal ECG (FECG) and Maternal ECG (MECG) signal.
Note: while this standard applies to certain EQUIPMENT, manufacturers may consider relevant requirements of this standards for testing similar equipment not in scope.
DIAGNOSTIC ECG ME EQUIPMENT
Any ECG ME EQUIPMENT that acquires and/or displays, records, analyzes, or transmits a 12 LEAD2 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. 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 acquires and/or displays, records, analyzes, or transmits an ECG signal from an ambulatory PATIENT. Examples of AMBULATORY ECG ME EQUIPMENT include Holter systems and continuous long-term ambulatory full disclosure recording systems; Holter recorders, mobile cardiac telemetry and long-term ambulatory patch recorders, event recorders, and non-continuous loop recorders. 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 and/or displays, records, analyzes, or transmits an ECG for the purpose of monitoring the cardiac activity of one PATIENT and devices used as part of an ALARM SYSTEM. This includes displaying ECG, displaying measurements such as heart rate, and generating alarms based on analysis of the ECG. It also includes devices where ECG or ECG-derived information device is intended to be relied upon in deciding to take immediate clinical action. Examples of MONITORING ECG EQUIPMENT include ECG and hardwired bedside patient monitors, telemetry systems, and other system used to identify of patient conditions requiring intervention based on manual and/or automated analysis of the ECG signal.
ECG TRUNK CABLES and PATIENT LEAD WIRES
ECG TRUNK CABLES and PATIENT LEAD WIRES that are used in applications that require special characteristics, such as a magnetic resonance imaging (MRI) suite, are excluded from this standard. However, non-MRI ECG TRUNK CABLES and PATIENT LEAD WIRES must meet all of the requirements of this standard, unless a requirement is specifically excluded.
ECG ELECTRODES
This standard establishes minimum labeling, safety, and performance requirements for disposable ECG ELECTRODES.
Included within the scope of this standard is any disposable ECG ELECTRODE SYSTEM.
ELECTRODES excluded from the scope of this standard are active ELECTRODES, needle ELECTRODES, reusable (non-disposable) ELECTRODES, ELECTRODES intended to deliver therapeutic energy, and ELECTRODES intended solely for the measurement of physiologic signals other than the ELECTROCARDIOGRAM (e.g., ELECTRODES used with apnea monitors, if the ELECTRODE is solely used for non-ECG purposes, e.g., impedance plethysmography). Also, requirements for electrolyte composition are not covered by this standard.
—————————
2 Unless otherwise specified, the term 12 LEAD indicates 12 or more LEADs, including at least the limb LEADs and precordial LEADs, as defined elsewhere in this document.
