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IEC 60601-2-10

Medical electrical equipment – Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

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Organization: IEC
Publication Date: 1 April 2016
Status: active
Page Count: 90
ICS Code (Therapy equipment): 11.040.60
scope:

Replacement:

This International Standard specifies the requirements for the safety of nerve and muscle STIMULATORS, defined in subclause 201.3.204, for use in the practice of physical medicine, hereinafter referred to as ME 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 ME EQUIPMENT is excluded:

- ME EQUIPMENT intended to be implanted or to be connected to implanted electrodes;

- ME EQUIPMENT intended for the stimulation of the brain (e.g. electroconvulsive therapy ME EQUIPMENT);

- ME EQUIPMENT intended for neurological research;

- external cardiac pacemakers (see IEC 60601-2-31);

- ME EQUIPMENT intended for averaged evoked potential diagnosis (see IEC 60601-2-40);

- ME EQUIPMENT intended for electromyography (see IEC 60601-2-40);

- ME EQUIPMENT intended for cardiac defibrillation (see IEC 60601-2-4).

 

Document History

IEC 60601-2-10
April 1, 2016
Medical electrical equipment – Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
Replacement: This International Standard specifies the requirements for the safety of nerve and muscle STIMULATORS, defined in subclause 201.3.204, for use in the practice of physical medicine,...
April 1, 2016
AMENDMENT 1 Medical electrical equipment – Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
A description is not available for this item.
June 1, 2012
Medical electrical equipment – Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
Replacement: This International Standard specifies the requirements for the safety of nerve and muscle STIMULATORS, defined in subclause 201.3.204, for use in the practice of physical medicine,...
February 1, 2002
Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Nerve and Muscle Stimulators
Scope and object This clause of the General Standard applies except as follows: Addition : This Particular Standard specifies the requirements for the safety of NERVE AND MUSCLE STIMULATORS, as...
September 1, 2001
Amendment 1 Medical electrical equipment – Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
At the end of the 4th dashed item add: (partly covered by IEC 60601-2-31) At the end of the 7th dashed item add: (covered by IEC 60601-2-40) At the end of the 8th dashed item add: (covered by IEC...
January 1, 1987
Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Nerve and Muscle Stimulators First Edition
Addition: This Particular Standard specifies the requirements for the safety of NERVE AND MUSCLE STIMULATORS, as defined in Sub-clause 2.1.101, for use in the practice of physical medicine,...

References

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