BS EN 80601-2-30:2010+A1:2015

Clause1 of the general standard1) applies, except as follows: 201.1.1 Scope Replacement: This International Standard applies to the basic safety and essential performance of automated sphygmomanometers, hereafter referred to as me equipment, which by means of an inflatable cuff, are used for non-continuous indirect measurement of the blood pressure without arterial puncture. NOTE1 Equipment that performs indirect measurement of the blood pressure without arterial puncture does not directly measure the blood pressure. It only estimates the blood pressure. This standard specifies requirements for the basic safety and essential performance for this me equipment and its accessories, including the requirements for the accuracy of a determination. This standard covers electrically-powered intermittent, indirect measurement of the blood pressure without arterial puncture, me equipment with automatic methods for estimating blood pressure, including blood pressure monitors for the home healthcare environment. Requirements for indirect measurement of the blood pressure without arterial puncture me equipment with an electrically-powered pressure transducer and/or displays used in conjunction with a stethoscope or other manual methods for determining blood pressure (non-automated sphygmomanometers) are specified in document ISO81060-1. If a clause or subclause is specifically intended to be applicable to me equipment only, or to me systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to me equipment and to me systems, as relevant. Hazards inherent in the intended physiological function of me equipment or me systems within the scope of this standard are not covered by specific requirements in this standard except in 201.11 and 201.105.3.3, as well as 7.2.13 and 8.4.1 of IEC60601-1. NOTE2 See also 4.2 of the general standard. 201.1.2 Object Replacement: The object of this particular standard is to establish particular basic safety and essential performance requirements for an automated sphygmomanometer as defined in 201.3.201. 201.1.3 Collateral standards Addition: This particular standard refers to those applicable collateral standards that are listed in Clause2 of IEC60601-1 and Clause2 of this particular standard. IEC60601-1-2 is amended by this particular standard. IEC60601-1-3 does not apply. All other published collateral standards in the IEC60601-1 series apply as published. 201.1.4 Particular standards Replacement: In the IEC60601 series, particular standards may modify, replace or delete requirements contained in the general standard and its 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, IEC60601-1 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 Clause1 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 Clause4 of the 60601-1-2 collateral standard, 203.4 in this particular standard addresses the content of Clause4 of the 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 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 201.101. 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 or figures 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 IEC60601-1-2, 203 for IEC60601-1-3, etc. The term \'this standard\' is used to make reference to the general standard, any applicable collateral standards and this particular standard taken together. 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.