IEC 60601-2-10 Nerve and Muscle Stimulators Testing
Medical electrical equipment – Part 2-10: the basic safety and essential performance of nerve and muscle stimulators
IEC 60601-2-10 Scope:
IEC 60601 2 10 and EN 60601 2 10 testing specifies the requirements for the safety of nerve and muscle stimulators, defined in sub-clause 201.3.204, for use in the practice of physical medicine, hereinafter referred to as medical electronic equipment. This includes transcutaneous electrical nerve stimulators (TENS) and electrical muscle stimulators (EMS).
NOTE A muscle stimulator may also be known as a neuromuscular stimulator.
The following medical electronic equipment is excluded from IEC 60601-2-10 testing:
- Medical electronic equipment intended to be implanted or to be connected to implanted electrodes;
- Medical electronic equipment intended for the stimulation of the brain (e.g. electroconvulsive therapy ME equipment);
- Medical electronic equipment intended for neurological research;
- External cardiac pacemakers (see IEC 60601-2-31);
- Medical electronic equipment intended for averaged evoked potential diagnosis (see IEC 60601-2-40);
- Medical electronic equipment intended for electromyography (see IEC 60601-2-40);
- Medical electronic equipment intended for cardiac defibrillation (see IEC 60601-2-4).
Keystone Compliance assists manufacturers with IEC 60601-2-10 and EN 60601-2-10 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-2-10 test lab needs.