AS 60601.2.10:2018 pdf free

AS 60601.2.10:2018 pdf free.Medical electrical equipment
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:
Subclauses, figures or tables which are additional to those of the general standard are numbered starting from 201.101. However due to the fact that 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.
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.
The instructions for use shall contain additionally:
a) Information on the output WAVEFORM(s), including any d.c. component, PULSE DURATIONS,PULSE repetition frequencies, maximum amplitude of output voltage and/or current, and the effect of load impedance on these parameters.
b) Advice on the size and type of electrodes to be used and the method of application for each particular type of treatment for which the STIMULATOR is intended.
c) Advice on any necessary precautions to be taken when the output contains a d.c.component.
d) Advice that a PATIENT with an implanted electronic device (for example a cardiac pacemaker) should not be subjected to stimulation unless specialist medical opinion has first been obtained.AS 60601.2.10 pdf free download.