ANSI AAMI IEC 60601-2-16-2012 pdf free download – Medical electrical equipment — Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems.
This standard does not apply to systems that do not continuously record and analyze the Ecc(for example， ‘intermittent event recorders”).
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIALPERFORMANCE requirements for AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS.
201.1.3 Collateral Standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in Clause 2of 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 andIEC 60601-1-10 do not apply.All other published collateral standards in the IEC 60601-1 seriesapply as published.
201.1.4Particular standardsReplacement:
In the IEC 60601 series，particular standards may modify，replace or delete requirementscontained in the general standard and collateral standards as appropriate for the particularME EQUIPMENT under consideration,and may add other BASIC SAFETY and ESSENTIALPERFORMANCE 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 thegeneral standard with the prefix “201″ (e.g. 201.1 in this standard addresses the content ofClause 1 of the general standard) or applicable collateral standard with the prefix “20x”where xis the final digit(s) of the collateral standard document number (e.g.202.4 in this particularstandard addresses the content of Clause 4 of the lEC 60601-1-2 collateral standard, 203.4 inthis particular standard addresses the content of Clause 4 of the IEC 60601-1-3 collateralstandard,etc.).The changes to the text of the general standard are specified by the use of thefollowing words:
“Replacement”means that the clause or subclause of the general standard or applicablecollateral 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 thegeneral standard or applicable collateral standard.
“Amendment” means that the clause or subclause of the general standard or applicable collateralstandard 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 numberedstarting from 201.101. However,due to the fact that definitions in the general standard arenumbered 3.1 through 3.139,additional definitions in this standard are numbered beginning from201.3.201.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 numberedstarting from 20x,where “x” is the number of the collateral standard, e.g. 202 for lEC 60601-1-2,203 for IEC 60601-1-3,etc.
The term “this standard” is used to make reference to the general standard, any applicablecollateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause orsubclause of the general standard or applicable collateral standard，although possibly notrelevant,applies without modification; where it is intended that any part of the general standardor applicable collateral standard, although possibly relevant, is not to be applied, a statement tothat effect is given in this particular standard.
201.2 Normative references
Clause 2 of the general standard applies, except as follows:
Amendment:
lEC 60601-1-2:2007，Medical electrical equipment – Part 1-2: General requirements for basicsafety and essential performance – Collateral standard: Electromagnetic compatibility -Requirements and tests.ANSI AAMI IEC 60601-2-16 pdf download.