ANSI/AAMI/ IEC 60601- 2-25:2011 pdf download – Medical electrical equipment – Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular requirements for BASIC SAFETY and
ESSENTIAL PERFORMANCE of ELECTROCARDIOGRAPHS as defined in 201.3.63.
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.
201.7.9.2 Instructions for use Additional subclause: 201.7.9.2.101 Additional instructions for use a) Advice shall be given on the following . 1) the INTENDED USE of the ELECTROCARDIOGRAPH including the environment of use. This disclosure shall include all the attributes of INTENDED USE such as, but not limited to, the following: i) diagnostic application(s) for which the ELECTROCARDIOGRAPH is intended (e.g. screening for cardiac abnormalities in the general population, detecting acute myocardial ischemia and infarction in chest pain PATIENTS, etc.); population(s) for whom the ELECTROCARDIOGRAPH is intended (e.g.: adults, children, infants, neonates, etc. – specify the age limits of the targeted population where applicable); il) location(s) for which the ELECTROCARDIOGRAPH is intended (e.g.: hospital, general physician’s office, out-of-hospital locations such as ambulance, home-care, etc.). If the ELECTROCARDIOGRAPH has more than one INTENDED USE with different attributes, all the INTENDED USES and associated attributes shall be disclosed; 2) instructions for connecting a POTENTIAL EQUALIZATION CONDUCTOR, if applicable; 3) that conductive parts of ELECTRODES and associated connectors for TYPE BF or CF APPLIED PARTS， including the NEUTRAL ELECTRODE， should not contact any other conductive parts including earth; 4) the specification (and type number, if necessary) of the PATIENT CABLE which needs to be used to provide protection against the effect of the discharge of a cardiac defibrillator and against high-frequency burns; 5) precautions to take when using a defibrillator on a PATIENT; a description of how the discharge of a defibrillator affects the ME EQUIPMENT; a warning that defibrillator protection requires use of MANUFACTURER specified ACCESSORIES including ELECTRODES,LEAD WIRES . and PATIENT CABLES. The specification (or type-number) of such ACCESSORIES (see 201 .8.5.5.1) shall be disclosed; .