IEC 60601-2-34:2000

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
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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
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– 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
...