IEC 60601-2-34:2000

Medical electrical equipment - Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment

Establishes particular requirements for the safety, including the essential performance of invasive blood pressure monitoring and measuring equipment. This particular standard takes into account Collateral Standard 60601-1-2:(1993) Electromagnetic compatibility and Collateral Standard 60601-1-4:(1996) Medical electrical equipment incorporating programmable electrical systems. A section on alarms has been included because alarms are necessary for monitoring equipment.

Appareils électromédicaux - Partie 2-34: Règles particulières de sécurité et de performances essentielles pour les appareils de surveillance de la pression sanguine prélevée directement

Etablit des règles particulières de sécurité, y compris des exigences de performances essentielles pour les appareils de surveillance et de mesure de la pression sanguine prélevée directement. La présente norme particulière prend en compte la Norme Collatérale 60601-1-2: (1993) Compatibilité Électromagnétique et la Norme Collatérale 60601-1-4: (1996) Systèmes électromédicaux programmables. Une section concernant les alarmes a été ajoutée car les alarmes sont nécessaires pour les appareils de surveillance.

General Information

• Status: Published
• Publication Date: 12-Oct-2000
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 19-May-2011

Relations

• Revised: IEC 60601-2-34:2011 - Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
• Effective Date: 05-Sep-2023

Standards Content (Sample)

INTERNATIONAL IEC
STANDARD
60601-2-34
Second edition
2000-10
Medical electrical equipment –
Part 2-34:
Particular requirements for the safety, including
essential performance, of invasive blood pressure
monitoring equipment
Appareils électromédicaux –
Partie 2-34:
Règles particulières de sécurité pour les appareils de
surveillance de la pression sanguine prélevée directement
Reference number
Publication numbering
As from 1 January 1997 all IEC publications are issued with a designation in the
60000 series. For example, IEC 34-1 is now referred to as IEC 60034-1.
Consolidated editions
The IEC is now publishing consolidated versions of its publications. For example,
edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the base publication, the
base publication incorporating amendment 1 and the base publication incorporating
amendments 1 and 2.
Further information on IEC publications
The technical content of IEC publications is kept under constant review by the IEC,
thus ensuring that the content reflects current technology. Information relating to
this publication, including its validity, is available in the IEC Catalogue of
publications (see below) in addition to new editions, amendments and corrigenda.
Information on the subjects under consideration and work in progress undertaken
by the technical committee which has prepared this publication, as well as the list
of publications issued, is also available from the following:
• IEC Web Site (www.iec.ch)
• Catalogue of IEC publications
The on-line catalogue on the IEC web site (www.iec.ch/catlg-e.htm) enables
you to search by a v ariety of criteria including text searches, technical
committees and date of publication. On-line information is also available on
recently issued publications, withdrawn and replaced publications, as well as
corrigenda.
• IEC Just Published
This summary of recently issued publications (www.iec.ch/JP.htm) is also
available by email. Please contact the Customer Service Centre (see below) for
further information.
• Customer Service Centre
If you have any questions regarding this publication or need further assistance,
please contact the Customer Service Centre:
Email: [e-mail]
Tel: [phone]
Fax: [phone]
INTERNATIONAL IEC
STANDARD
60601-2-34
Second edition
2000-10
Medical electrical equipment –
Part 2-34:
Particular requirements for the safety, including
essential performance, of invasive blood pressure
monitoring equipment
Appareils électromédicaux –
Partie 2-34:
Règles particulières de sécurité pour les appareils de
surveillance de la pression sanguine prélevée directement
 IEC 2000  Copyright - all rights reserved
No part of this publication may be reproduced or utiliz ed in an y form or b y any means, electronic or
mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: [phone] e-mail: [e-mail] IEC web site http://www.iec.ch
Commission Electrotechnique Internationale
PRICE CODE
U
International Electrotechnical Commission
For price, see current catalogue

– 2 – 60601-2-34 © IEC:2000(E)
CONTENTS
Page
FOREWORD . 4
INTRODUCTION .6
Clause
SECTION ONE – GENERAL
1 Scope and object . 7
2 Terminology and definitions . 8
4 General requirements for tests. 10
5 Classification .10
6 Identification, marking and documents . 10
SECTION TWO – ENVIRONMENTAL CONDITIONS
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
14 Requirements related to classification. 11
17 Separation . 12
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS . 12
20 Dielectric strength. 13
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength. 13
SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
36 ELECTROMAGNETIC COMPATIBILITY. 14
SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION OF
FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
42 Excessive temperatures . 17
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization,
disinfection and compatibility . 17
45 Pressure vessel and parts subject to pressure . 18
46 Humman errors . 19
SECTION EIGHT – ACCURACY OF OPERATION DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data . 19
51 Protection against hazardous output . 19
SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly. 29
57 Mains parts, components and layout . 29

60601-2-34 © IEC:2000(E) – 3 –
Annex AA (informative) Guidance and rationale for particular clauses and subclauses . 46
Annex BB (informative) ALARM diagrams . 55
INDEX of defined terms. 58
Bibliography . 59
Figure 101 – Measuring circuit for PATIENT LEAKAGE CURRENT via an F-TYPE (FLOATING)
earth caused by an external voltage on the APPLIED PART . 30
Figure 102 – Dynamic test for limitation of energy from different parts – Recovery test . 31
Figure 103 – Measuring circuit for the PATIENT LEAKAGE CURRENT from the APPLIED PART
to earth of CLASS I EQUIPMENT caused by an external voltage on the FUNCTIONAL
EARTH TERMINAL . 32
Figure 104 – Measuring circuit for the PATIENT LEAKAGE CURRENT from the APPLIED PART
to EARTH of INTERNALLY POWERED EQUIPMENT, caused by an external voltage on
a FUNCTIONAL EARTH TERMINAL. 33
Figure 105 – Clarification of leakage current tests . 34
Figure 106 – Diaphragm leak test. 35
Figure 107 – Over-pressure test. 35
Figure 108 – Test layout for conducted and radiated emission and radiated immunity test. 36
Figure 109 – Test circuit for high-frequency surgery interference measurement,
when the PATIENT isolation is in the monitor. 37
Figure 110 – Test circuit for HIGH-FREQUENCY surgery interference measurement, when
the PATIENT isolation is in the TRANSDUCER . 38
Figure 111 – Test set-up for HIGH-FREQUENCY SURGICAL EQUIPMENT
interference measurement. 39
Figure 112 – Test for accuracy of pressure measurements. 40
Figure 113 – Test for sensitivity, repeatability, non-linearity, drift and hysteresis. 41
Figure 114 – Pressure measurement system for accuracy of systolic and diastolic
pressure. 42
Figure 115 – Frequency response of EQUIPMENT and TRANSDUCER . 43
Figure 116 – Test for ALARM DELAY . 44
Figure 117 – Test for ALARM DELAY . 45
Figure AA.1 – Pressure TRANSDUCER error band . 54

– 4 – 60601-2-34 © IEC:2000(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION
––––––––––––
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-34: Particular requirements for the safety,
including essential performance, of invasive blood
pressure monitoring equipment
FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The o bject of the IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end a nd in addition to other activities, the IEC publishes International Standards. Their preparation is
entrusted to technical committees; any I EC 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. The 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 the IEC on t echnical matters express, as nearly as possible, an
international consensus of opinion on the relevant subjects since each technical committee has representation
from all interested National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical specifications, technical reports or g uides and they are accepted by the National
Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60601-2-34 has been prepared by subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This second edition of IEC 60601-2-34 cancels and replaces the first edition published in
1994 and constitutes a technical revision.
The text of this standard is based on the following documents:
FDIS Report on voting
62D/367/FDIS 62D/373/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 3.
Annexes AA and BB are for information only.

60601-2-34 © IEC:2000(E) – 5 –
This Particular Standard amends and supplements IEC 60601-1 (second edition 1988):
Medical Electrical Equipment – Part 1: General Requirements for Safety, modified by
amendment 1 and amendment 2, hereinafter referred to as the General Standard. The
requirements of this Particular Standard take priority over those of the General Standard.
In this Particular Standard the following print types are used:
– requirements, compliance with which can be tested and definitions: in roman type;
– notes, explanations, advice, introductions, general statements, exceptions and references: in smaller type;
– test specifications, headings of subclauses and headings of items: in italic type:
– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR THIS PARTICULAR STANDARD: SMALL
CAPITALS.
The committee has decided that the contents of this publication will remain unchanged until
2005. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
A bilingual version of this standard may be issued at a later date.

– 6 – 60601-2-34 © IEC:2000(E)
INTRODUCTION
The General Standard does not include requirements specific to the safety, including
essential performance, of DIRECT BLOOD PRESSURE MONITORING EQUIPMENT. Hence, changes
need to be made to include these unique requirements. This particular standard takes into
account Collateral Standard 60601-1-2:(1993) Electromagnetic compatibility and Collateral
Standard 60601-1-4:(1996) Medical electrical equipment incorporating programmable
electrical systems. A sectio
...

IEC 60601-2-34
Edition 2.0 2000-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-34: Particular requirements for the safety, including esssential
performance, of invasive blood pressure monitoring equipment

Appareils électromédicaux –
Partie 2-34: Règles particulières de sécurité et de performances essentielles
pour les appareils de surveillance de la pression sanguine prélevée directement

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
3, rue de Varembé
CH-1211 Geneva 20
Switzerland
Email: [e-mail]
Web: 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.
ƒ Catalogue of IEC publications: www.iec.ch/searchpub
The IEC on-line Catalogue enables you to search by a variety of criteria (reference number, text, technical committee,…).
It also gives information on projects, withdrawn and replaced publications.
ƒ IEC Just Published: www.iec.ch/online_news/justpub
Stay up to date on all new IEC publications. Just Published details twice a month all new publications released. Available
on-line and also by email.
ƒ Electropedia: www.electropedia.org
The world's leading online dictionary of electronic and electrical terms containing more than 20 000 terms and definitions
in English and French, with equivalent terms in additional languages. Also known as the International Electrotechnical
Vocabulary online.
ƒ Customer Service Centre: www.iec.ch/webstore/custserv
If you wish to give us your feedback on this publication or need further assistance, please visit the Customer Service
Centre FAQ or contact us:
Email: [e-mail]
Tel.: [phone]
Fax: [phone]
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.
ƒ Catalogue des publications de la CEI: www.iec.ch/searchpub/cur_fut-f.htm
Le Catalogue en-ligne de la CEI vous permet d’effectuer des recherches en utilisant différents critères (numéro de référence,
texte, comité d’études,…). Il donne aussi des informations sur les projets et les publications retirées ou remplacées.
ƒ Just Published CEI: www.iec.ch/online_news/justpub
Restez informé sur les nouvelles publications de la CEI. Just Published détaille deux fois par mois les nouvelles
publications parues. Disponible en-ligne et aussi par email.
ƒ Electropedia: www.electropedia.org
Le premier dictionnaire en ligne au monde de termes électroniques et électriques. Il contient plus de 20 000 termes et
définitions en anglais et en français, ainsi que les termes équivalents dans les langues additionnelles. Egalement appelé
Vocabulaire Electrotechnique International en ligne.
ƒ Service Clients: www.iec.ch/webstore/custserv/custserv_entry-f.htm
Si vous désirez nous donner des commentaires sur cette publication ou si vous avez des questions, visitez le FAQ du
Service clients ou contactez-nous:
Email: [e-mail]
Tél.: [phone]
Fax: [phone]
IEC 60601-2-34
Edition 2.0 2000-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-34: Particular requirements for the safety, including esssential
performance, of invasive blood pressure monitoring equipment

Appareils électromédicaux –
Partie 2-34: Règles particulières de sécurité et de performances essentielles
pour les appareils de surveillance de la pression sanguine prélevée directement

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XA
CODE PRIX
ICS 11.040.55 ISBN 2-8318-8254-0
– 2 – 60601-2-34 © CEI:2000
SOMMAIRE
AVANT-PROPOS .6
INTRODUCTION.10

SECTION UN – GÉNÉRALITÉS
1 Domaine d'application et objet .12
2 Terminologie et définitions .14
4 Exigences générales relatives aux essais .18
5 Classification .18
6 Identification, marquage et documentation .18

SECTION DEUX – CONDITIONS D'ENVIRONNEMENT

SECTION TROIS – PROTECTION CONTRE LES RISQUES DE CHOCS ÉLECTRIQUES
14 Exigences relatives à la classification .20
17 Séparation.22
19 COURANTS DE FUITE permanents et COURANTS AUXILLIAIRES PATIENT.22
20 Tension de tenue .24

SECTION QUATRE – PROTECTION CONTRE LES RISQUES MÉCANIQUES
21 Résistance mécanique.24

SECTION CINQ – PROTECTION CONTRE LES RISQUES DUS AUX RAYONNEMENTS
NON DÉSIRÉS OU EXCESSIFS
36 Compatibilité électromagnétique .26

SECTION SIX – PROTECTION CONTRE LES RISQUES D'IGNITION
DE MÉLANGES ANESTHÉSIQUES INFLAMMABLES

SECTION SEPT – PROTECTION CONTRE LES TEMPÉRATURES EXCESSIVES
ET AUTRES RISQUES
42 Températures excessives.32
44 Débordements, renversements, fuites, humidité, pénétration de liquides, nettoyage,
stérilisation, désinfection et compatibilité .32
45 Réservoir sous pression et parties sous pression .34
46 Erreurs humaines .34

SECTION HUIT – PRÉCISION DES CARACTÉRISTIQUES DE FONCTIONNEMENT
ET PROTECTION CONTRE LES CARACTÉRISTIQUES DE FONCTIONNEMENT
PRÉSENTANT DES RISQUES
50 Précision des caractéristiques de fonctionnement .36
51 Protection contre les caractéristiques de sortie présentant des risques.36

SECTION NEUF – FONCTIONNEMENT ANORMAL ET CONDITIONS DE DÉFAUT;
ESSAIS D'ENVIRONNEMENT
SECTION DIX – RÈGLES DE CONSTRUCTION

60601-2-34 © IEC:2000 – 3 –
CONTENTS
FOREWORD.7
INTRODUCTION.11

SECTION ONE – GENERAL
1 Scope and object.13
2 Terminology and definitions.15
4 General requirements for tests .19
5 Classification.19
6 Identification, marking and documents.19
SECTION TWO – ENVIRONMENTAL CONDITIONS
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
14 Requirements related to classification .21
17 Separation.23
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS .23
20 Dielectric strength.25
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength .25
SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
36 Electromagnetic compatibility.27
SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION OF
FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
42 Excessive temperatures.33
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization,
disinfection and compatibility.33
45 Pressure vessel and parts subject to pressure.35
46 Humman errors.35
SECTION EIGHT – ACCURACY OF OPERATION DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data .37
51 Protection against hazardous output.37
SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
SECTION TEN – CONSTRUCTIONAL REQUIREMENTS

– 4 – 60601-2-34 © CEI:2000
56 Composants et ensembles.56
57 Parties reliées au réseau, composants et montage.56

Annexe AA (informative) Guide et justifications des articles et paragraphes particuliers .90
Annexe BB (informative) Schémas d'ALARMES. 108

INDEX des termes définis . 114

Bibliographie . 116

FIGURE 101 – Circuit de mesure du COURANT DE FUITE PATIENT via une terre de TYPE-F
(FLOTTANTE) dû à une tension externe sur la PARTIE APPLIQUEE.58
FIGURE 102 – Essai dynamique de limitation de l'énergie issue de différentes parties –
Essai de rétablissement .60
FIGURE 103 – Circuit de mesure du COURANT DE FUITE PATIENT s'écoulant d'une PARTIE
APPLIQUEE vers la terre d'un APPAREIL DE LA CLASSE I dû à une tension externe sur la
BORNE DE TERRE FONCTIONNELLE. .62
FIGURE 104 – Circuit de mesure du COURANT DE FUITE PATIENT s'écoulant de la PARTIE
APPLIQUEE vers la TERRE D'UN APPAREIL A SOURCE ELECTRIQUE INTERNE dû à une tension
externe sur la BORNE DE TERRE FONCTIONNELLE .64
FIGURE 105 – Explication des essais de courant de fuite .66
FIGURE 106 – Essai de fuite de diaphragme .68
FIGURE 107 – Essai de surpression .68
FIGURE 108 – Montage d'essai pour les émissions conduites et rayonnées et essai
d'immunité aux rayonnements .70
FIGURE 109 – Circuit d'essai pour la mesure des interférences des appareils
chirurgicaux à haute fréquence lorsque l'isolation du PATIENT est dans le moniteur .72
FIGURE 110 – Circuit d'essai pour la mesure des interférences chirurgicales à haute
fréquence lorsque l'isolation du PATIENT est dans le TRANSDU
...