AAMI IEC-60601-2-27-2011 pdf download.Medical electrical equipment Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment.
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 arid 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 201W (e.g. 2011 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:
“Replacemenr means that the clause or subclause of the general standard or applicable collateral standard is replaced completely by the text of this particular standard.
“Addifion 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 sub.clause of the general standard or applicable collateral standard is amended as indicated by the text of this particular standard.
Subcleuses, 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 .1 through .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.
Subclauses, figures or tables which are additional to those of a collateral standard are numbered starting from 20*. where x is the number of the collateral standard, e.g. 202 for IEC 60601-1.2. 203 for IEC 60601-1-3, etc.
The term fhis standard is used to make reference to the general standard, any applicable collateral standards and this particular standard taken together.
2 2011 AssocIation for the MvcemenI of Medlc listrumentatbon • ANSI.AAMLIEC 60601-2-27:2011
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.
201.2 Normative references
Clause 2 of the general standard applies, except as follows:
Replacement.
IEC 60601-1-2:2007, Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral standard, Electromagnetic compatibility — Requirements and tests
lEG 60601.1-8:2008, Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collaterat standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
Addition:
IEC 60601-2-2:2009, Medical electrical equipment — Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories.AAMI IEC-60601-2-27 pdf download.