ANSI/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.
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 60601-1-2:2007 and IEC 60601-1-8:2006 apply as modified in Clauses 202 and 208 respectively, lEG 60601-1-3 does not apply. All other published collateral standards in the IEC 6060 1-1 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 (he 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 I 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:
“Replacement” means that the clause or subclause of the general standard or applicable collateral standard is replaced completely by the text or 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.
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, 203 for IEC 60601-1-3, etc.
The term “this standard” is used to make reference to the general standard, any applicable collateral standards and this particular standard taken together.
201.5.8 *Sequence of tests Amendment: Tests called for in 201.8.5.5.1 of this particular standard and in 8.5.5 of the general standard shall be carried out prior to the LEAKAGE CURRENT and dielectric strength tests described in subclauses 8.7 and 8.8 of the general standard and prior to the tests specified in subclauses 201.11.6.5 and 201.12.1.101 of this particular standard. The tests for subclauses 201.12.1.101.7, 201.12.1.101.9 and 201.12.1.101.16 b) shall be performed (in that order) before the tests for the remaining subclauses of 201.12.1.101 are performed. 201.6 Classification of ME EQUIPMENT and ME SYSTEMS Clause 6 of the general standard applies, except as follows: 201.6.2 *Protection against electric shock Replacement of the last paragraph: APPLIED PARTS shall be classified as TYPE CF APPLIED PARTS (see 7.2.10 and 8.3 of the general standard). APPLIED PARTS shall be classified as DEFIBRILLATION-PROOF APPLIED PARTS (see 8.5.5 of the general standard).