AAMI IEC 60601-2-25 pdf download

AAMI IEC 60601-2-25 pdf download.MEDICAL ELECTRICAL EQUIPMENT – Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
201 .1 .1 Scope
Replacement: This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROCARDIOGRAPHS as defined in 201 .3.63 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. NOTE 1 For example. M E EQUIPMENT includes: a) direct-writing ELECTROCARDIOGRAPHS ; b) other ME EQUIPMENT that produce ECG REPORTS for diagnostic purposes, e.g. patient monitors, defibrillators, exercise testing devices; c) ELECTROCARDIOGRAPHS having a display that is remote from the PATIENT (e.g. via phone lines, networks or storage media). These ME EQUIPMENT or ME SYSTEMS are within the scope of this particular standard excluding transmission media. NOTE 2 M E EQUIPMENT that provide selection between diagnostic and monitoring functions shall meet the requirements of the appropriate standard when configured for that function. M E EQUIPMENT intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician’s 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.
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 .1 01 . However due to the fact that definitions in the general standard are numbered 3.1 through 3.1 39, 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.Subclauses, figures or tables which are additional to those of a collateral standard are numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601 -1 -2, etc. The term “this standard” is used to make reference to the general standard, any applicable collateral standards and this particular standard taken together. 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.