BS EN IEC 80601-2-30:2019 - Medical electrical equipment. Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

BS EN IEC 80601-2-30:2019

Medical electrical equipment. Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

Status : Current   Published : July 2019

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IEC 80601-2-30:2018 is also available as

IEC 80601-2-30:2018 RLV

which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.



IEC 80601-2-30:2018 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. 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. 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. This second edition cancels and replaces the first edition published in 2009 and Amendment 1:2013. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:


a) alignment with IEC 60601-1:2005/AMD1:2012 and IEC 60601-1-8:2006/AMD1:2012 , and with IEC 60601-1-2:2014 and IEC 60601-1-11:2015;


b) referencing IEC 60601-1-10:2007 and IEC 60601-1-12;


c) changing an operator-accessible cuff-sphygmomanometer connector from not compatible with the ISO 594 series to compatible with the ISO 80369 series;


d) added additional requirements for public self-use sphygmomanometers;


e) added a list of primary operating functions.




Standard NumberBS EN IEC 80601-2-30:2019
TitleMedical electrical equipment. Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
StatusCurrent
Publication Date03 July 2019
Normative References(Required to achieve compliance to this standard)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
Informative References(Provided for Information)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
ReplacesBS EN 80601-2-30:2010+A1:2015
International RelationshipsEN IEC 80601-2-30:2019,IEC 80601-2-30:2018
DescriptorsClinical investigation instruments, Domestic, Sphygmomanometers, Electronic equipment and components, Medical equipment, Automatic, Performance, Electrical safety, Electrical equipment, Patient monitors, Safety measures, Electrical medical equipment
ICS11.040.01
11.040.55
Title in FrenchAppareils électromédicaux Exigences particulières pour la sécurité de base et les performances essentielles de sphygmomanomètres non invasifs automatiques
Title in GermanMedizinische elektrische Geräte Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von automatisierten nicht-invasiven Blutdruckmessgeräten
CommitteeCH/62/4
ISBN978 0 539 05222 0
PublisherBSI
FormatA4
DeliveryYes
Pages64
File Size1.308 MB
Price£254.00


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