IEC EN 60601-2-10 Medical Electrical Equipment - Part 2-10: Particular Requirements for Basic Safety and Essential Performance of Nerve and Muscle Stimulators

The standard “IEC EN 60601-2-10 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators”, which is based on a European standard and subsequently published by the International Electrotechnical Commission (IEC), describes the requirements for the safety of nerve and muscle stimulators for use in physical medicine practice.

This standard also includes transcutaneous (through the skin) electrical nerve stimulators and electrical muscle stimulators. A muscle stimulator is also known as a neuromuscular stimulator.

However, the following types of medical equipment are outside the scope of this standard:

• Medical equipment designed to be implanted or connected to implanted electrodes
• Medical equipment designed to stimulate the brain (e.g. electroconvulsive therapy medical equipment)
• Medical equipment designed for neurological research
• External pacemakers (these fall within the scope of the IEC 60601-2-31 standard)
• Medical equipment intended for the diagnosis of average evoked potential (these fall within the scope of the IEC 60601-2-40 standard)
• Medical equipment designed for electromyography (these fall within the scope of the IEC 60601-2-40 standard)
• Medical equipment designed for cardiac defibrillation (these fall within the scope of the IEC 60601-2-4 standard)

The purpose of this standard is to specify certain basic safety and essential performance requirements for nerve and muscle stimulators.

When voltage and current values ​​are used in this standard, they mean the RMS values ​​of an alternating, direct or compound voltage or current averaged over 1 second, unless otherwise stated.

Nerve and muscle stimulators are a method that sends electrical impulses to nerves that cause muscles to contract by mimicking the action potential from the central nervous system. It can be applied during or without functional movement. This method has been used for years to strengthen and maintain muscle strength and prevent atrophy, especially in immobile patients. Some studies suggest that peripheral nerve stimulators can successfully treat postoperative and acute pain with minimal need for analgesics.

The electrical current used in these stimulants stimulates nerve cells that block the transmission of pain signals. This changes the way pain is perceived. The electrical current increases the level of endorphins (the body's natural pain-killing chemicals), which triggers the body's pain-killing power.

For the purposes of this standard, the following terms and definitions apply in addition to those given in IEC 60601-1:

• A lead is an insulated conductor that has a means of connecting to a stimulator at one end and to an electrode at the other end and is designed to transmit output signals from a stimulator to an electrode.
• A pulse refers to the portion of the waveform between two zero voltage levels.
• Pulse duration refers to the duration of the output pulse at 50 percent of maximum amplitude.
• Stimulator refers to medical equipment for applying electric current through electrodes that are in direct contact with the patient, for the diagnosis or treatment of neuromuscular disorders.
• A waveform is the variation in amplitude of an electrical signal output from an applied part (as voltage or current) as a function of time.

The following have been added to the general requirements in this standard:

• In the case of combined medical equipment (e.g. a stimulator equipped with a function or an applied part for ultrasonic therapy), the additional part must comply with any relevant specific standard.
• Manufacturers must include in their risk analysis the risk of the potential use of their stimulators and accessories to deliver current exceeding 10 mA or current densities exceeding 2 mA/cm2 for any electrode.
• Medical equipment should be operated in output mode and the load that produces the highest amplitude steady-state current should be used.
• The nominal input power of a mains-operated exciter shall be the maximum power averaged over any 5-second period under operating conditions as specified by the manufacturer.
• Medical equipment capable of delivering an output greater than 1 mA or 10 Volts averaged over any 10 second period should be marked near the electrode connections with the number 10 symbol from the table provided in the standard.

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