AAMI IEC 60601-2-25 pdf free download

AAMI IEC 60601-2-25 pdf free download.Medical electrical equipment – Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs.
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this particular standard.
IEC 60601-1-2 applies as modified in Clause 202. IEC 60601-1-3, IEC 60601-1-8 and IEC 60601-1-10 do not apply. All other published collateral standards in the IEC 60601-1 series apply as published
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard. Collateral standards are referred to by their document number.
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 60601-1-2 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words:
“Replacement” means that the clause or subclause of the general standard or applicable collateral standard is replaced completely by the text of this particular standard.
“Addition” means that the text of this particular standard is additional to the requirements of the general standard or applicable collateral standard.
“Amendment” means that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this particular standard.
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.
Within 5 s after exposure to the defibrillation voltage, the ME EQUIPMENT shall resume normal operation in the previous operating mode, without loss of any OPERATOR settings or stored data, and shall continue to perform its intended function as specified in the ACCOMPANYING DOCUMENTS.
Compliance is checked according to Figure 201.103.
For ME EQUIPMENT of CLASS I, apply the test voltage between all LEAD WIRES, including the
NEUTRAL ELECTRODE, connected together and the FUNCTIONAL EARTH TERMINAL. Energize the
ME EQUIPMENT for these tests.
In the case of ME EQUIPMENT of CLASS II and ME EQUIPMENT with an INTERNAL ELECTRICAL POWER SOURCE, apply the test voltage between all LEAD WIRES, including the NEUTRAL ELECTRODE, connected together and the FUNCTIONAL EARTH TERMINAL and/or metal foil in close contact with the ENCLOSURE. Energize the ME EQUIPMENT for these tests.
Eco MONITORING EQUIPMENT having an INTERNAL ELECTRICAL POWER SOURCE, which is rechargeable from the SUPPLY MAINS, shall be tested with and without the SUPPLY MAINS connection if the ME EQUIPMENT is capable of operating while connected to SUPPLY MAINS.
Set the GAIN of the ME EQUIPMENT so that a 5 mV signal produces a maximum display deflection without clipping the signal. With S2 closed and S3 opened, adjust the 10 Hz sine wave generator to produce a 5 mV peak-to-valley output signal. Open switch S2 and close S3.AAMI IEC 60601-2-25 pdf download.