IEC 80601-2-30:2018
(Main)Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
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.
Appareils électromédicaux - Partie 2-30: Exigences particulières pour la sécurité de base et les performances essentielles des sphygmomanomètres non invasifs automatiques
L’IEC 80601-2-30:2018 s'applique à la sécurité de base et aux performances essentielles des sphygmomanomètres automatiques, ci-après dénommés appareils EM, qui, au moyen d'un brassard gonflable, sont utilisés pour l'estimation indirecte non continue de la pression artérielle sans ponction artérielle. Le présent document spécifie les exigences pour la sécurité de base et les performances essentielles de ces appareils EM et leurs accessoires, y compris les exigences relatives à l'exactitude de la détermination de la pression artérielle. Le présent document couvre les appareils EM automatiques à énergie électrique utilisés pour l'estimation indirecte intermittente de la pression artérielle sans ponction artérielle, y compris les moniteurs de pression artérielle pour l'environnement des soins à domicile. Les exigences relatives aux appareils EM d'estimation indirecte de la pression artérielle sans ponction artérielle comportant un transducteur de pression à énergie électrique et/ou des affichages utilisés conjointement avec un stéthoscope ou autres méthodes manuelles de détermination de la pression artérielle (sphygmomanomètres non automatiques) sont spécifiées dans l'ISO 81060-1. Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux appareils EM ou uniquement aux systèmes EM, le titre et le contenu de cet article ou de ce paragraphe l'indiquent. Si tel n'est pas le cas, l'article ou le paragraphe s'applique à la fois aux appareils EM et aux systèmes EM, selon le cas. Les dangers inhérents à la fonction physiologique prévue des appareils EM ou des systèmes EM dans le cadre du domaine d'application du présent document ne sont pas couverts par des exigences spécifiques contenues dans le présent document, à l'exception de 201.11 et 201.105.3.3, ainsi que 7.2.13 et 8.4.1 de l'IEC 60601-1:2005. Cette deuxième édition annule et remplace la première édition parue en 2009 et son Amendement 1:2013. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente:
a) alignement avec l'IEC 60601-1:2005/AMD1:2012 et l'IEC 60601 1 8:2006/AMD1:2012, et avec l'IEC 60601-1-2:2014 et l'IEC 60601-1-11:2015;
b) référence à l'IEC 60601-1-10:2007 et à l'IEC 60601-1-12;
c) modification d'un connecteur brassard-sphygmomanomètre accessible à l'operateur non compatible avec la série ISO 594 en un connecteur compatible avec la série ISO 80369;
d) ajout d'exigences supplémentaires relatives aux sphygmomanomètres à usage autonome dans les zones publiques;
e) ajout d'une liste de fonctions principales de service.
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IEC 80601-2-30
Edition 2.0 2018-03
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 2-30: Particular requirements for the basic safety and essential performance
of automated non-invasive sphygmomanometers
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
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About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
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The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.
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IEC 80601-2-30
Edition 2.0 2018-03
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 2-30: Particular requirements for the basic safety and essential performance
of automated non-invasive sphygmomanometers
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.01 ISBN 978-2-8322-5515-5
– 2 – IEC 80601-2-30:2018 RLV © IEC 2018
CONTENTS
FOREWORD . 4
INTRODUCTION . 2
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions. 11
201.4 General requirements . 14
201.5 General requirements for testing ME EQUIPMENT . 14
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 14
201.7 ME EQUIPMENT identification, marking and documents . 14
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 18
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 19
201.10 Protection against unwanted and excessive radiation HAZARDS . 19
201.11 Protection against excessive temperatures and other HAZARDS . 19
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 20
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 25
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 25
201.15 Construction of ME EQUIPMENT . 25
201.16 ME SYSTEMS . 27
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 27
201.101 Requirements for CUFFS . 27
201.102 * Connection tubing and CUFF connectors . 28
201.103 Unauthorized access. 28
201.104 * Maximum inflating time . 28
201.105 * Automatic cycling modes . 29
201.106 * Clinical accuracy . 33
202 Electromagnetic compatibility disturbances – Requirements and tests . 33
206 Usability . 37
210 Requirements for the development of physiologic closed-loop controllers . 38
211 Requirements for medical electrical equipment and medical electrical
systems used in the home healthcare environment . 38
212 Requirements for medical electrical equipment and medical electrical
systems intended for use in the emergency medical services environment . 38
Annexes . 39
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 40
Annex AA (informative) Particular guidance and rationale . 43
Annex BB (informative) Environmental aspects . 53
Annex CC (informative) Reference to the ESSENTIAL PRINCIPLES . 54
Bibliography . 54
Index of defined terms . 61
Figure 201.101 – CUFF pressure PROTECTION DEVICE, triggered by overpressure
in SINGLE FAULT CONDITION . 22
Figure 201.102 – CUFF pressure PROTECTION DEVICE, triggered by prolonged
overpressure in SINGLE FAULT CONDITION . 23
Figure 201.103 – CUFF pressure and maximum inflation time, NORMAL CONDITION
and SINGLE FAULT CONDITION . 29
Figure 201.104 – LONG-TERM AUTOMATIC MODE CUFF pressure in NORMAL CONDITION . 30
Figure 201.105 – LONG-TERM AUTOMATIC MODE CUFF pressure in SINGLE FAULT CONDITION . 31
Figure 201.106 – SHORT-TERM AUTOMATIC MODE CUFF pressure . 31
Figure 201.107 – SELF-MEASUREMENT AUTOMATIC MODE CUFF pressure . 32
Figure 202.101 – HF SURGICAL EQUIPMENT test layout . 36
Figure 202.102 – Simulated PATIENT test set-up for HF SURGICAL EQUIPMENT . 37
Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements . 14
Table 201.102 – CUFF deflation pressure . 19
Table 201.103 – CUFF inflation pressure . 28
Table 201.C.101 – Marking on the outside of AUTOMATED SPHYGMOMANOMETERS
or their parts . 40
Table 201.C.102 – Marking of controls and instruments of AUTOMATED
SPHYGMOMANOMETERS or their parts . 41
Table 201.C.103 – ACCOMPANYING DOCUMENTS, general information for AUTOMATED
SPHYGMOMANOMETERS . 41
Table 201.C.104 – ACCOMPANYING DOCUMENTS, instructions for use of AUTOMATED
SPHYGMOMANOMETERS . 41
Table 201.C.105 – ACCOMPANYING DOCUMENTS, technical description of AUTOMATED
SPHYGMOMANOMETERS . 42
Table AA.1 – Summary of requirements by mode . 50
Table BB.1 – Environmental aspects addressed by clauses of this document . 53
Table CC.1 – Correspondence between this particular standard
and the ESSENTIAL PRINCIPLES . 54
– 4 – IEC 80601-2-30:2018 RLV © IEC 2018
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-30: Particular requirements for the basic safety
and essential performance of automated non-invasive
sphygmomanometers
FOREWORD
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...
IEC 80601-2-30
Edition 2.0 2018-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-30: Particular requirements for the basic safety and essential performance
of automated non-invasive sphygmomanometers
Appareils électromédicaux –
Partie 2-30: Exigences particulières pour la sécurité de base et les performances
essentielles des sphygmomanomètres non invasifs automatiques
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
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About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.
IEC Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
The stand-alone application for consulting the entire The world's leading online dictionary of electronic and
bibliographical information on IEC International Standards, electrical terms containing 21 000 terms and definitions in
Technical Specifications, Technical Reports and other English and French, with equivalent terms in 16 additional
documents. Available for PC, Mac OS, Android Tablets and languages. Also known as the International Electrotechnical
iPad. Vocabulary (IEV) online.
IEC publications search - webstore.iec.ch/advsearchform IEC Glossary - std.iec.ch/glossary
The advanced search enables to find IEC publications by a 67 000 electrotechnical terminology entries in English and
variety of criteria (reference number, text, technical French extracted from the Terms and Definitions clause of
committee,…). It also gives information on projects, replaced IEC publications issued since 2002. Some entries have been
and withdrawn publications. collected from earlier publications of IEC TC 37, 77, 86 and
CISPR.
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IEC 80601-2-30
Edition 2.0 2018-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-30: Particular requirements for the basic safety and essential performance
of automated non-invasive sphygmomanometers
Appareils électromédicaux –
Partie 2-30: Exigences particulières pour la sécurité de base et les performances
essentielles des sphygmomanomètres non invasifs automatiques
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.01 ISBN 978-2-8322-5425-7
– 2 – IEC 80601-2-30:2018 © IEC 2018
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions. 11
201.4 General requirements . 13
201.5 General requirements for testing ME EQUIPMENT . 13
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 14
201.7 ME EQUIPMENT identification, marking and documents . 14
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 17
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 18
201.10 Protection against unwanted and excessive radiation HAZARDS . 18
201.11 Protection against excessive temperatures and other HAZARDS . 18
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 19
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 24
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 24
201.15 Construction of ME EQUIPMENT . 24
201.16 ME SYSTEMS . 25
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 25
201.101 Requirements for CUFFS . 25
201.102 * Connection tubing and CUFF connectors . 26
201.103 Unauthorized access. 26
201.104 * Maximum inflating time . 26
201.105 * Automatic cycling modes . 27
201.106 * Clinical accuracy . 31
202 Electromagnetic disturbances – Requirements and tests . 31
206 Usability . 34
210 Requirements for the development of physiologic closed-loop controllers . 35
211 Requirements for medical electrical equipment and medical electrical
systems used in the home healthcare environment . 35
212 Requirements for medical electrical equipment and medical electrical
systems intended for use in the emergency medical services environment . 35
Annexes . 37
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 38
Annex AA (informative) Particular guidance and rationale . 41
Annex BB (informative) Environmental aspects . 50
Annex CC (informative) Reference to the ESSENTIAL PRINCIPLES . 51
Bibliography . 54
Index of defined terms . 56
Figure 201.101 – CUFF pressure PROTECTION DEVICE, triggered by overpressure in SINGLE
FAULT CONDITION . 21
Figure 201.102 – CUFF pressure PROTECTION DEVICE, triggered by prolonged overpressure
in SINGLE FAULT CONDITION . 22
Figure 201.103 – CUFF pressure and maximum inflation time, NORMAL CONDITION and
SINGLE FAULT CONDITION . 27
Figure 201.104 – LONG-TERM AUTOMATIC MODE CUFF pressure in NORMAL CONDITION . 28
Figure 201.105 – LONG-TERM AUTOMATIC MODE CUFF pressure in SINGLE FAULT CONDITION . 28
Figure 201.106 – SHORT-TERM AUTOMATIC MODE CUFF pressure . 29
Figure 201.107 – SELF-MEASUREMENT AUTOMATIC MODE CUFF pressure . 30
Figure 202.101 – HF SURGICAL EQUIPMENT test layout . 33
Figure 202.102 – Simulated PATIENT test set-up for HF SURGICAL EQUIPMENT . 34
Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements . 13
Table 201.102 – CUFF deflation pressure . 18
Table 201.103 – CUFF inflation pressure . 26
Table 201.C.101 – Marking on the outside of AUTOMATED SPHYGMOMANOMETERS or
their parts . 38
Table 201.C.102 – Marking of controls and instruments of AUTOMATED
SPHYGMOMANOMETERS or their parts . 38
Table 201.C.103 – ACCOMPANYING DOCUMENTS, general information for AUTOMATED
SPHYGMOMANOMETERS . 39
Table 201.C.104 – ACCOMPANYING DOCUMENTS, instructions for use of AUTOMATED
SPHYGMOMANOMETERS . 39
Table 201.C.105 – ACCOMPANYING DOCUMENTS, technical description of AUTOMATED
SPHYGMOMANOMETERS . 40
Table AA.1 – Summary of requirements by mode . 47
Table BB.1 – Environmental aspects addressed by clauses of this document . 50
Table CC.1 – Correspondence between this particular standard and the ESSENTIAL
PRINCIPLES . 51
– 4 – IEC 80601-2-30:2018 © IEC 2018
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-30: Particular requirements for the
...
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