IEC 80601-2-30:2018 

Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

Note: a redline version of this publication exists
IEC 80601-2-30:2018 RLV

English/French
CHF 

Do you need a multi-user copy?

English/French
CHF 

Preview

Abstract

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.

Look inside


Additional information

Publication typeInternational Standard
Publication date2018-03-22
Edition2.0
Available language(s)English/French
TC/SCTC 62/SC 62D - Particular medical equipment, software, and systemsrss
ICS11.040.01 - Medical equipment in general
Stability date  2025
Pages117
File size2064 KB

The following test report forms are related:



Share your publications

Learn how to share your publications with your colleagues, using networking options.

Payment information

Our prices are in Swiss francs (CHF). We accept all major credit cards (American Express, Mastercard and Visa, JCB and CUP), PayPal and bank transfers as form of payment.


Keep in touch

Keep up to date with new publication releases and announcements with our free IEC Just Published email newsletter.

Contact customer services

Please send your enquiry by email or call us on +41 22 919 02 11 between 09:00 – 16:00 CET Monday to Friday.