Standards Development

Scope

Clause 1 of the general standard[1]) applies, except as follows:

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 201.3.211, 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 lead[2] 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.

Replacement:

The object of this particular standard is to establish basic safety and essential performance requirements for ecg me equipment.

The requirements in this particular standard are organized into the following types of requirements:

1) General requirements – all requirements are considered general requirements and apply to all types of ecg me equipment unless explicitly noted.

2) Diagnostic requirements specific to diagnostic ecg me equipment will be explicitly identified as such.

3) Monitoring requirements specific to monitoring ecg me equipment will be explicitly identified as such.

4) Ambulatory requirements specific to ambulatory ecg me equipment will be explicitly identified as such.

Additionally, the following requirements have been added to this particular standard:

 ecg trunk cable and lead wires, as in ANSI/AAMI EC53. These requirements apply to any ecg me equipment, including monitoring, diagnostic, and ambulatory ecg me equipment.

 disposable ecg electrode, as in ANSI/AAMI EC12. These requirements apply to any ecg me equipment that includes disposable ecg electrodes as an applied part.

 Requirements from the last edition of 60601-2-51 that were omitted when it was combined with 60601-2-25.

A summary of requirements for compliance to this standard for ecg me equipment are listed in Table AA.1 – AA.4 in Annex AA.

Addition:

This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this particular standard.

IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020, and IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012 and IEC 60601-1-8:2006/AMD2:2020 apply as modified in Clauses 202 and 208 respectively. All other published collateral standards in the IEC 60601-1 series apply as published.

Replacement:

In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard and collateral standards as appropriate for the particular ecg me equipment under consideration, and may add other basic safety and essential performance requirements.

A requirement of a particular standard takes priority over the general standard.

For brevity, IEC 60601-1 is referred to in this particular standard as the general standard. Collateral standards are referred to by their document number.

The numbering of clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x” where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words:

“Replacement” means that the clause or subclause of the general standard or applicable collateral standard is replaced completely by the text of this particular standard.

“Addition” means that the text of this particular standard is additional to the requirements of the general standard or applicable collateral standard.

“Amendment” means that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this particular standard.

Subclauses, Figures or Tables which are additional to those of the general standard are numbered starting from 201.101. However, because definitions in the general standard are numbered 3.1 through 3.139, additional definitions in this standard are numbered beginning from 201.3.201. Additional Annexes are lettered AA, BB, etc., and additional items aa), bb), etc.

Subclauses, Figures or Tables which are additional to those of a collateral standard are numbered starting from 20x, where “x” is the final digit(s) of the collateral standard, e.g. 202 for IEC 60601-1-2, 203 for IEC 60601-1-3, etc.

The term “this standard” is used to reference to the general standard, any applicable collateral standards and this particular standard taken together.

Where there is no corresponding clause or subclause in this particular standard, the clause or subclause of the general standard or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of the general standard or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard.