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19687-89
ME EQUIPMENT intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physicians office, such as
in ambulances and air transport, shall comply with this particular standard. Additional standards may apply to ME EQUIPMENT for those environments of use.
This second edition cancels and replaces the first edition of IEC 60601-2-25, published in 1993 and the first edition of IEC 60601-2-51, published in 2003.
This second edition of IEC 60601-2-25 constitutes a technical revision of both those standards.
ELECTROCARDIOGRAPHS intended by themselves or as a part of an ME SYSTEM, for the production of ECG REPORTS for diagnostic purposes,
hereinafter referred to as ME EQUIPMENT.
Not included within the scope of this particular standard are:
a) the part of ME EQUIPMENT that provides vectorcardiographic loops;
b) ambulatory electrocardiographic ME EQUIPMENT covered by IEC 60601-2-47 where not intended for obtaining ECG REPORTS for diagnostic purposes;
c) cardiac monitors covered by IEC 60601-2-27 where not intended for obtaining ECG REPORTS for diagnostic purposes.
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201.3.202 CHANNEL
hardware and/or software selection of a particular electrocardiographic
LEAD for purposes of display, recording, or transmission
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201.3.209 FILTER
means, realized in hardware, firmware or software, to attenuate unwanted
components in the signal being recorded, e.g. muscle action voltages in an
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201.3.208 ELECTRODE
sensor in contact with a specified part of the body that is used to detect
electrical activity
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201.3.210 GAIN
ratio of the amplitude of the output signal to the amplitude of the input signal
NOTE GAIN is expressed in mm/mV.
201.3.214 NOISE
unwanted signals of any frequency present in the ELECTROCARDIOGRAM
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