IEC 80601-2-30:2009

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

IEC 80601-2-30:2009 applies to the basic safety and essential performance of automated sphygmomanometers, which by means of an inflatable cuff are used for intermittent indirect measurement of the blood pressure without arterial puncture. It 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. This first edition of IEC 80601-2-30 cancels and replaces the second edition of IEC 60601-2-30, published in 1999. This edition constitutes a major technical revision as well as an alignment with the third edition of IEC 60601-1. Specific technical changes include: expansion of the scope to include all automated sphygmomanometers including those where the patient is the operator, identification of essential performance, new clinical accuracy requirements, additional mechanical strength requirements and prohibition of operator accessible 'Luer' connectors in the pneumatic system. The contents of the corrigendum of January 2010 have been included in this copy.

Appareils électromédicaux - Partie 2-30: Exigences particulières pour la sécurité de base et les performances essentielles de sphygmomanomètres non invasifs automatiques

La CEI 80601-2-30:2009 s'applique à la sécurité de base et aux performances essentielles des sphygmomanomètres automatiques qui, au moyen d'un brassard gonflable, sont utilisés pour la mesure indirecte intermittente de la pression artérielle sans ponction artérielle. Elle couvre les appareils em à énergie électrique de mesure indirecte intermittente de la pression artérielle sans ponction artérielle, comportant des méthodes automatiques pour l'estimation de la pression artérielle, y compris les moniteurs de pression artérielle pour l'environnement des soins à domicile. Cette première édition de la CEI 80601-2-30 annule et remplace la deuxième édition de la CEI 60601-2-30, publiée en 1999. La présente édition constitue une révision technique de grande ampleur et permet un alignement avec la troisième édition de la CEI 60601-1. Les changements techniques spécifiques incluent: l'extension du domaine d'application de manière à inclure tous les sphygmomanomètres automatiques, y compris ceux avec lesquels le patient est l'opérateur, l'identification des performances essentielles, les nouvelles exigences en matière de validation clinique, les exigences supplémentaires relatives à la résistance mécanique et l'interdiction de l'usage des connecteurs de type Luer accessibles à l'opérateur dans le système pneumatique. Le contenu du corrigendum de janvier 2010 a été pris en considération dans cet exemplaire.

General Information

• Status: Published
• Publication Date: 30-Jul-2013
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Drafting Committee: JWG 7 - TC 62/SC 62D/JWG 7
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 22-Mar-2018

Relations

• Replaces: IEC 60601-2-30:1999 - Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
• Effective Date: 05-Sep-2023
• Amended By: IEC 80601-2-30:2009/AMD1:2013 - Amendment 1 - Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated type non-invasive sphygmomanometers
• Effective Date: 05-Sep-2023
• Corrected By: IEC 80601-2-30:2009/COR1:2010 - Corrigendum 1 - Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
• Effective Date: 05-Sep-2023
• Revised: 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
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 80601-2-30
Edition 1.0 2009-01
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 either IEC or

IEC's member National Committee in the country of the requester.
If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication,
please contact the address below or your local IEC member National Committee for further information.

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IEC 80601-2-30
Edition 1.0 2009-01
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
PRICE CODE
INTERNATIONALE
XA
CODE PRIX
ICS 11.040 ISBN 978-2-88910-781-0

– 2 – 80601-2-30 © IEC:2009
CONTENTS
FOREWORD.4

INTRODUCTION.7

201.1 Scope, object and related standards .8

201.2 Normative references.10

201.3 Terms and definitions.10

201.4 General requirements .13

201.5 General requirements for testing ME EQUIPMENT .13

201.6 Classification of ME EQUIPMENT and ME SYSTEMS.13
201.7 ME EQUIPMENT identification, marking and documents .13
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 .23
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).23
201.15 Construction of ME EQUIPMENT .23
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 compatibility – Requirements and tests .31
Annexes .34
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS.35

Annex AA (informative) Particular guidance and rationale.38
Annex BB (informative) Environmental aspects .46
Annex CC (informative) Reference to the essential principles .47
Bibliography.49
Index of defined terms .51

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

80601-2-30 © IEC:2009 – 3 –
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 .35
Table 201.C.102 – Marking of controls and instruments of AUTOMATED
SPHYGMOMANOMETERS or their parts .36
Table 201.C.103 – ACCOMPANYING DOCUMENTS, general information for AUTOMATED
SPHYGMOMANOMETERS .36
Table 201.C.104 – ACCOMPANYING DOCUMENTS, instructions for use of AUTOMATED
SPHYGMOMANOMETERS .36
Table 201.C.105 – ACCOMPANYING DOCUMENTS, technical description of AUTOMATED
SPHYGMOMANOMETERS .37
Table AA.1 – Summary of requirements by mode.43
Table BB.1 – Environmental aspects addressed by clauses of this standard .46
Table CC.1 – Correspondence between this particular standard and the essential
principles .47

– 4 – 80601-2-30 © IEC:2009
INTERNATIONAL ELECTROTECHNICAL COMMISSION

____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-30: Particular requirements for the basic safety and essential

performance of automated non-invasive sphygmomanometers

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
...

IEC 80601-2-30
Edition 1.1 2013-07
CONSOLIDATED
VERSION
VERSION
CONSOLIDÉE
colour
inside
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
either IEC or IEC's member National Committee in the country of the requester.
If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication,

please contact the address below or your local IEC member National Committee for further information.

Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite ni
utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie et les

microfilms, sans l'accord écrit de la CEI ou du Comité national de la CEI du pays du demandeur.

Si vous avez des questions sur le copyright de la CEI ou si vous désirez obtenir des droits supplémentaires sur cette

publication, utilisez les coordonnées ci-après ou contactez le Comité national de la CEI de votre pays de résidence.

IEC Central Office Tel.: [phone]
3, rue de Varembé Fax: [phone]
CH-1211 Geneva 20 [e-mail]
Switzerland www.iec.ch
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.

Useful links:
IEC publications search - www.iec.ch/searchpub Electropedia - www.electropedia.org
The advanced search enables you to find IEC publications The world's leading online dictionary of electronic and
by a variety of criteria (reference number, text, technical electrical terms containing more than 30 000 terms and
committee,…). definitions in English and French, with equivalent terms in
It also gives information on projects, replaced and additional languages. Also known as the International
withdrawn publications. Electrotechnical Vocabulary (IEV) on-line.

IEC Just Published - webstore.iec.ch/justpublished Customer Service Centre - webstore.iec.ch/csc
Stay up to date on all new IEC publications. Just Published If you wish to give us your feedback on this publication
details all new publications released. Available on-line and or need further assistance, please contact the
also once a month by email. Customer Service Centre: [e-mail].

A propos de la CEI
La Commission Electrotechnique Internationale (CEI) est la première organisation mondiale qui élabore et publie des
Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.

A propos des publications CEI
Le contenu technique des publications de la CEI est constamment revu. Veuillez vous assurer que vous possédez
l’édition la plus récente, un corrigendum ou amendement peut avoir été publié.

Liens utiles:
Recherche de publications CEI - www.iec.ch/searchpub Electropedia - www.electropedia.org
La recherche avancée vous permet de trouver des Le premier dictionnaire en ligne au monde de termes
publications CEI en utilisant différents critères (numéro de électroniques et électriques. Il contient plus de 30 000
référence, texte, comité d’études,…). termes et définitions en anglais et en français, ainsi que
Elle donne aussi des informations sur les projets et les les termes équivalents dans les langues additionnelles.
publications remplacées ou retirées. Egalement appelé Vocabulaire Electrotechnique
International (VEI) en ligne.
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Restez informé sur les nouvelles publications de la CEI.
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Disponible en ligne et aussi une fois par mois par email. cette publication ou si vous avez des questions
contactez-nous: [e-mail].
IEC 80601-2-30
Edition 1.1 2013-07
CONSOLIDATED
VERSION
VERSION
CONSOLIDÉE
colour
inside
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 ISBN 978-2-8322-1013-0

IEC 80601-2-30
Edition 1.1 2013-07
REDLINE VERSION
VERSION REDLINE
colour
inside
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

– 2 – 80601-2-30  IEC:2009+A1:2013

CONTENTS
FOREWORD . 4

INTRODUCTION . 7

INTRODUCTION TO THE AMENDMENT . 8

201.1 Scope, object and related standards . 9

201.2 Normative references . 11

201.3 Terms and definitions. 12

201.4 General requirements . 14
201.5 General requirements for testing ME EQUIPMENT . 15
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 15
201.7 ME EQUIPMENT identification, marking and documents . 15
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 19
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 . 21
201.13 HAZARDOUS SITUATIONS and fault conditions . 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 . 34
202 Electromagnetic compatibility – Requirements and tests . 34
206 USABILITY . 37

211 Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL
SYSTEMS used in the home healthcare environment . 37
Annexes . 38
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 39
Annex AA (informative) Particular guidance and rationale . 42
Annex BB (informative) Environmental aspects . 50
Annex CC (informative) Reference to the essential principles . 51
Bibliography . 53
Index of defined terms . 55

Figure 201.101 – CUFF pressure PROTECTION DEVICE, triggered by overpressure in
SINGLE FAULT CONDITION . 22

80601-2-30  IEC:2009+A1:2013 – 3 –

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 . 30

Figure 201.106 – SHORT-TERM AUTOMATIC MODE CUFF pressure . 31

Figure 201.107 – SELF-MEASUREMENT AUTOMATIC MODE CUFF pressure . 33

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 . 20
Table 201.103 – CUFF inflation pressure . 28
Table 201.C.101 – Marking on the outside of AUTOMATED SPHYGMOMANOMETERS or their
parts . 39
Table 201.C.102 – Marking of controls and instruments of AUTOMATED
SPHYGMOMANOMETERS or their parts . 40
Table 201.C.103 – ACCOMPANYING DOCUMENTS, general information for AUTOMATED
SPHYGMOMANOMETERS . 40
Table 201.C.104 – ACCOMPANYING DOCUMENTS, instructions for use of AUTOMATED
SPHYGMOMANOMETERS . 40
Table 201.C.105 – ACCOMPANYING DOCUMENTS, technical description of AUTOMATED
SPHYGMOMANOMETERS . 41
Table AA.1 – Summary of requirements by mode . 48
Table BB.1 – Environmental aspects addressed by clauses of this standard . 50
Table CC.1 – Correspondence between this particular standard and the essential
principles . 51

– 4 – 80601-2-30  IEC:2009+A1:2013

INTERNATIONAL ELECTROTECHNICAL COMMISSION

____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-30: Particular requirements for the basic safety and essential

performance of automated non-invasive sphygmomanometers

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards,
...