This part of the 80601 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 estimation of the BLOOD PRESSURE without arterial puncture.

NOTE 1 Equipment that performs indirect DETERMINATION of the BLOOD PRESSURE without arterial puncture does not directly measure the BLOOD PRESSURE. It only estimates the BLOOD PRESSURE.

This document 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 document covers automatic electrically-powered ME EQUIPMENT used for the intermittent, indirect estimation of the BLOOD PRESSURE without arterial puncture, including BLOOD PRESSURE monitors for the HOME HEALTHCARE ENVIRONMENT.

Requirements for indirect estimation 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 ISO 81060-1 [2].

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 document are not covered by specific requirements in this document except in 201.11 and 201.105.3.3, as well as 7.2.13 and 8.4.1 of IEC 60601-1:2005.

NOTE 2 See also 4.2 of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.

Cross References:
EN 60601-1-3
ISO 80369-1
IEC 60601-1-6:2010/AMD1:2013
EN 60601-1-2:2015
IEC 60601-1-2:2014
IEC 62366-1:2015
EN 60068-2-64:2008
EN 60601-1-11:2015
EN 60601-1:2006/corrigendum Mar. 2010
IEC 60601-1-12:2014
IEC 60601-2-2:2017
EN 60068-2-27:2009
EN 62366-1:2015
EN 60601-1:2006/A1:2013
IEC 60068-2-27:2008
IEC 60601-1-11:2015
EN 60601-1:2006/A12:2014
EN 62366-1:2015/AC:2015
EN 60601-1:2006
EN 60601-1-10:2008
EN 60601-1-6:2010
IEC 60601-1-10:2007
IEC 60068-2-64:2008
EN 60601-1-6:2010/A1:2015
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005
IEC 80369-5:2016
EN ISO 81060-2:2014
ISO 81060-2:2013
IEC 60601-1-6:2010
EN 60721-3-7
ISO 594-1:1986
ISO 9919:2005
CR 13825:2000
IEC 60601-1-8:2006
IEC 60601-1-9:2007
IEC 60601-1-8:2006/AMD1:2012
ISO 81060-1:2007
EN 60601-1-9:2008
EN 60601-1-8:2007
EN ISO 81060-1:2012
ISO 16142-1:2016
ISO 594-2:1991
ISO 21647:2004
IEC TR 60721-4-7
IEC 60721-3-7
IEC 60601-1-3


Replaces BS EN 80601-2-30:2010+A1:2015 which remains current

All current amendments available at time of purchase are included with the purchase of this document.