IEC 60601-2-34:2024

IEC 60601-2-34 ®
Edition 4.0 2024-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-34: Particular requirements for the basic safety and essential performance
of invasive blood pressure monitoring equipment

Appareils électromédicaux –
Partie 2-34: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de surveillance de la pression sanguine prélevée
directement
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IEC 60601-2-34 ®
Edition 4.0 2024-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –

Part 2-34: Particular requirements for the basic safety and essential

performance of invasive blood pressure monitoring equipment

Appareils électromédicaux –
Partie 2-34: Exigences particulières pour la sécurité de base et les

performances essentielles des appareils de surveillance de la pression

sanguine prélevée directement
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.55  ISBN 978-2-8322-9681-3

– 2 – IEC 60601-2-34:2024 © IEC 2024
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 . 12
201.5 General requirements for testing ME EQUIPMENT . 12
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 . 15
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 23
201.10 Protection against unwanted and excessive radiation HAZARDS . 23
201.11 Protection against excessive temperatures and other HAZARDS . 24
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 26
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 31
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 31
201.15 Construction of ME EQUIPMENT . 31
201.16 ME SYSTEMS . 32
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS. 32
202 Electromagnetic disturbances – Requirements and tests . 33
206 USABILITY . 38
208 General requirements, tests and guidance for alarm systems in MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS . 39
Annexes . 46
Annex AA (informative) Particular guidance and rationale . 47
Bibliography . 58
Index of defined terms used in this particular standard . 59

Figure 201.101 – Dynamic test for limitation of energy from different parts – Recovery
test 17
Figure 201.102 – Diaphragm leak test . 18
Figure 201.103 – Measuring circuit for PATIENT LEAKAGE CURRENT via the PATIENT
CONNECTION(S) of an F-TYPE APPLIED PART to earth caused by an external voltage on the
PATIENT CONNECTION(S). 19
Figure 201.104 – Measuring circuit for the PATIENT LEAKAGE CURRENT from the APPLIED
PART to earth of CLASS I ME EQUIPMENT caused by an external voltage on a metal
ACCESSIBLE PART that is not PROTECTIVELY EARTHED . 20
Figure 201.105 – Measuring circuit for the PATIENT LEAKAGE CURRENT from the APPLIED
PART to earth of INTERNALLY POWERED ME EQUIPMENT caused by an external voltage on
a metal ACCESSIBLE PART that is not PROTECTIVELY EARTHED . 21
Figure 201.106 – Clarification of leakage current tests . 22
Figure 201.107 – Over-pressure test . 23
Figure 201.108 – Test for accuracy of pressure measurements. 27

Figure 201.109 – Test sequence for sensitivity, repeatability, non-linearity, drift and
hysteresis . 28
Figure 201.110 – Pressure measurement system for accuracy of systolic and diastolic

pressure . 29
Figure 201.111 – Frequency response of ME EQUIPMENT and PRESSURE TRANSDUCER . 30
Figure 202.101 – Test layout for conducted and radiated EMISSION and radiated
immunity test . 34
Figure 202.102 – Test circuit for high-frequency surgery interference measurement,
when the isolation of the APPLIED PART is in the monitor . 36
Figure 202.103 – Test circuit for high-frequency surgery protection, when the isolation
of the APPLIED PART is in the PRESSURE TRANSDUCER . 37
Figure 202.104 – Test set-up for high-frequency surgery protection . 38
Figure 208.101 – Test for delay times of ALARM SIGNALS indicating PHYSIOLOGICAL
ALARM CONDITIONS . 42
Figure 208.102 – Test for delay times of ALARM SIGNALS indicating PHYSIOLOGICAL
ALARM CONDITIONS . 43
Figure AA.1 – PRESSURE TRANSDUCER error band . 54

Table 201.101 – ESSENTIAL PERFORMANCE requirements. 12

– 4 – IEC 60601-2-34:2024 © IEC 2024
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-34: Particular requirements for the basic safety and essential
performance of invasive blood pressure monitoring equipment

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
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Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
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4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
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any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
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6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
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Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) IEC draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). IEC takes no position concerning the evidence, validity or applicability of any claimed patent rights in
respect thereof. As of the date of publication of this document, IEC had not received notice of (a) patent(s), which
may be required to implement this document. However, implementers are cautioned that this may not represent
the latest information, which may be obtained from the patent database available at https://patents.iec.ch. IEC
shall not be held responsible for identifying any or all such patent rights.
IEC 60601-2-34 has been prepared by a Joint Working Group of IEC subcommittee 62D:
Particular medical equipment, software, and systems, of IEC technical committee 62: Medical
equipment, software, and systems, and ISO subcommittee SC3: Respiratory devices and
related equipment used for patient care, of ISO technical committee 121: Anaesthetic and
respiratory equipment. It is an International Standard.
This fourth edition cancels and replaces the third edition of IEC 60601-2-34 published in 2011
and constitutes a technical revision.

This edition includes the following significant technical changes with respect to the previous
edition:
a) revision to align with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020, as well as new versions of collateral standards and
amendments thereto;
b) expansion of the scope to the emergency medical service environment;
c) changed essential performance in Table 201.101;
d) changed requirement for ingress protection;
e) added primary operating functions;
f) deleted Annex BB Alarm diagrams.
The text of this International Standard is based on the following documents:
Draft Report on voting
62D/2155/FDIS 62D/2167/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this International Standard is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/publications.
In this document, the following print types are used:
– requirements and definitions: roman type;
– test specifications: italic type;
– informative material appearing outside of tables, such as notes, examples and references:
in smaller type. Normative text of tables is also in a smaller type;
– TERMS DEFINED IN CLAUSE 3 OF IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 AND
IEC 60601-1:2005/AMD2:2020, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS.
In referring to the structure of this document, the term
– "clause" means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– "subclause" means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this document are preceded by the term "Clause" followed by the
clause number. References to subclauses within this particular standard are by number only.
In this document, the conjunctive "or" is used as an "inclusive or" so a statement is true if any
combination of the conditions is true.

– 6 – IEC 60601-2-34:2024 © IEC 2024
The verbal forms used in this document conform to usage described in Clause 7 of the ISO/IEC
Directives, Part 2. For the purposes of this document, the auxiliary verb:
– "shall" means that compliance with a requirement or a test is mandatory for compliance with
this document;
– "should" means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
– "may" is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 and IEC 80601 series, published under the general title
Medical electrical equipment, can be found on the IEC website.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
• reconfirmed,
• withdrawn, or
• revised.
NOTE The attention of the users of this document is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised IEC publication in
which to make products in accordance with the new requirements and to equip themselves for conducting new or
revised tests. It is the recommendation of the committees that the content of this publication be adopted for
implementation nationally not earlier than 3 years from the date of publication.

INTRODUCTION
This document concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of INVASIVE BLOOD
PRESSURE MONITORING EQUIPMENT. It amends and supplements IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
The aim of this fourth edition is to bring this document up to date with reference to
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and new
versions of collateral standards and amendments thereto through technical changes.
The requirements of this document take priority over those of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and collateral standards.
A "General guidance and rationale" for the more important requirements of this document is
included in Annex AA. It is considered that knowledge of the reasons for these requirements
will not only facilitate the proper application of the standard but will, in due course, expedite
any revision necessitated by changes in clinical practice or as a result of developments in
technology. However, Annex AA does not form part of the requirements of this document.

– 8 – IEC 60601-2-34:2024 © IEC 2024
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-34: Particular requirements for the basic safety and essential
performance of invasive blood pressure monitoring equipment

201.1 Scope, object and related standards
Clause 1 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.1.1 *Scope
Replacement:
This part of IEC 60601 applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of INVASIVE BLOOD
PRESSURE MONITORING EQUIPMENT as defined in 201.3.63, hereinafter also referred to as
ME EQUIPMENT.
This document applies to INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT intended for use in
professional healthcare facilities and in the EMERGENCY MEDICAL SERVICE ENVIRONMENT.
This document does not apply to catheter tubing, catheter needles, Luer locks, taps and tap
tables that connect to the DOME.
This document does not apply to non-invasive blood pressure monitoring equipment.
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 follows:
The clause or subclause applies to ME EQUIPMENT, as default and, only if the corresponding
safety measure or function is not completely integrated into the ME EQUIPMENT but implemented
as part of an ME SYSTEM, the clause or subclause applies to the ME SYSTEM.
201.1.2 Object
Replacement:
The object of this particular standard is to establish BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT, as defined in 201.3.63.
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 and Clause 201.2 of this particular standard.
IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-6:2010,
IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020, IEC 60601-1-8:2006,
IEC 60601-1-8:2006/AMD1:2012 and IEC 60601-1-8:2006/AMD1:2020 apply as modified in
Clauses 202, 206 and 208 respectively. IEC 60601-1-3, IEC 60601-1-9 and IEC 60601-1-10 do
not apply. All other published collateral standards in the IEC 60601-1 series apply as published.

201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and collateral standards.
The numbering of clauses and subclauses of this particular standard corresponds to that of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 with the
prefix "201" (e.g. 201.1 in this document addresses the content of Clause 1 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020) or
applicable collateral standard with the prefix "20x" where x is the final digit(s) of the collateral
standard document number (e.g. 202.4 in this particular standard addresses the content of
Clause 4 of the IEC 60601-1-2 collateral standard, 208.4 in this particular standard addresses
the content of Clause 4 of the IEC 60601-1-8 collateral standard, etc.). The changes to the text
of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are
specified by the use of the following words:
"Replacement" means that the clause or subclause of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or applicable collateral
standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or
applicable collateral standard.
"Amendment" means that the clause or subclause of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or applicable collateral
standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are numbered starting from
201.101. However, due to the fact that definitions in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020d are numbered 3.1 through
3.154, additional definitions in this document are numbered beginning from 201.3.201.
Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where "x" is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 208 for IEC 60601-1-8, etc.
The term "this document" is used to make reference to IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, any applicable collateral
standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 or applicable collateral standard, although possibly not relevant,
applies without modification; where it is intended that any part of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or applicable collateral
standard, although possibly relevant, is not to be applied, a statement to that effect is given in
this particular standard.
– 10 – IEC 60601-2-34:2024 © IEC 2024
201.2 Normative references
Clause 2 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
NOTE Informative references are listed in the bibliography.
Replacement:
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic disturbances –
Requirements and tests
IEC 60601-1-2:2014/AMD1:2020
IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic
safety and essential performance – Collateral standard: Usability
IEC 60601-1-6:2010/AMD1:2013
IEC 60601-1-6:2010/AMD2:2020
IEC 60601-1-8:2006, Medical electrical equipment – Part 1-8: General requirements for basic
safety and essential performance – Collateral standard: General requirements, tests and
guidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 60601-1-8:2006/AMD1:2012
IEC 60601-1-8:2006/AMD2:2020
ISO 15223-1:2021, Medical devices – Symbols to be used with information to be supplied by
the manufacturer – Part 1: General requirements
Addition:
IEC 60529:1989, Degrees of protection provided by enclosures (IP Code)
IEC 60529:1989/AMD1:1999
IEC 60529:1989/AMD2:2013
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
IEC 60601-1-12:2014, Medical electrical equipment – Part 1-12: General requirements for basic
safety and essential performance – Collateral Standard: Requirements for medical electrical
equipment and medical electrical systems intended for use in the emergency medical services
environment
IEC 60601-1-12:2014/AMD1:2020
201.3 Terms and definitions
NOTE An Index of defined terms is found at the end of this document.
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-2:2005/AMD2:2020, IEC 60601-1-2:2014 and
IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013 and
IEC 60601-1-6:2010/AMD2:2020, IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012 and
IEC 60601-1-8:2006/AMD2:2020, IEC 60601-1-12:2014 and IEC 60601-1-12:2014/AMD1:2020
apply, except as follows:
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
Replacement:
201.3.8
APPLIED PART
PRESSURE TRANSDUCER, including its associated catheter and any fluid-filled system
201.3.63
INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT
MEDICAL ELECTRICAL EQUIPMENT including associated PRESSURE TRANSDUCERS, that is used for
internal measurement or monitoring of circulatory system pressures
Additional terms and definitions:
201.3.201
CATHETER
tubular device, single or multi-lumen, designed to be partially or totally inserted into the
cardiovascular system for diagnostic purposes
201.3.202
CATHETER TIP PRESSURE TRANSDUCER
PRESSURE TRANSDUCER mounted at, or close to, the tip of a CATHETER
201.3.203
DOME
means for hydraulically coupling the PATIENT'S blood pressure to a PRESSURE TRANSDUCER
external to the PATIENT
201.3.204
NOMINAL SENSITIVITY
ratio of the change in PRESSURE TRANSDUCER output to a change of the value of the pressure at
any selected pressure range
201.3.205
PRESSURE TRANSDUCER
device for converting pressure into an electrical signal

– 12 – IEC 60601-2-34:2024 © IEC 2024
201.4 General requirements
Clause 4 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
Additional subclause:
201.4.3.101 Additional ESSENTIAL PERFORMANCE requirements
Additional ESSENTIAL PERFORMANCE requirements for INVASIVE BLOOD PRESSURE MONITORING
EQUIPMENT are found in subclauses listed in Table 201.101.
Table 201.101 – ESSENTIAL PERFORMANCE requirements
Requirement Subclause
Defibrillator protection 201.8.5.5.1
Accuracy of pressure measurements 201.12.1.101
Electrosurgery interference 202.8.101
PHYSIOLOGICAL ALARM CONDITIONS 208.6.1.2.101
PRESSURE TRANSDUCER disconnect ALARM CONDITION 208.6.1.2.102
PRESSURE TRANSDUCER fault ALARM CONDITION 208.6.1.2.103
Catheter disconnect ALARM CONDITION 208.6.1.2.104
ALARM SYSTEM delays for PHYSIOLOGICAL ALARM CONDITIONS 208.6.4.1.101
ALARM SYSTEM delays for TECHNICAL ALARM CONDITIONS 208.6.4.1.102
Delays to or from a DISTRIBUTED INFORMATION SYSTEM ABOUT ALARM CONDITIONS (DIS) or a 208.6.4.2
DISTRIBUTED ALARM SYSTEM (DAS)

201.5 General requirements for testing ME EQUIPMENT
Clause 5 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.5.4 Other conditions
Addition:
If necessary for the purpose of conducting the test, the INTERNAL ELECTRICAL POWER SOURCE
can be replaced by an external battery or DC power supply to provide the appropriate test
voltage.
The values used in test circuits, unless otherwise specified, shall have at least an accuracy as
given below:
– resistors: ± 1 %;
– capacitors: ± 10 %;
– inductors: ± 10 %;
– test voltages: ± 1 %.
The temperature of the physiological saline solution shall be 25 °C ± 5 °C.

201.5.8 * Sequence of tests
Amendment:
Tests called for in 201.8.5.5.1 of this document and in 8.5.5 of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 shall be carried out prior to
the LEAKAGE CURRENT and dielectric strength tests described in 8.7 and 8.8 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and
prior to the tests specified in 201.12.1.101.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.6.2 * Protection against electric shock
Replacement of the last paragraph:
APPLIED PARTS shall be classified as TYPE CF APPLIED PARTS (see 7.2.10 and 8.3 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020).
APPLIED PARTS shall be classified as DEFIBRILLATION-PROOF APPLIED PARTS (see 8.5.5 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020).
201.6.6 Mode of operation
Replacement:
ME EQUIPMENT shall be classified for CONTINUOUS OPERATION (see 7.2.11).
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
201.7.2.10 APPLIED PARTS
Addition:
If fulfilment of TYPE CF APPLIED PART isolation depends on the PRESSURE TRANSDUCER, then
symbol 27, Table D.1 of IEC 60601-1:2005 shall be marked on the PRESSURE TRANSDUCER.
201.7.2.17 * Protective packaging
Addition:
The packaging of PRESSURE TRANSDUCER and DOMES supplied in sterile condition shall be
marked with symbol 5.2.1, 5.2.2, 5.2.3, 5.2.4 or 5.2.5 of ISO 15223-1:2021 and the time limit
for safe use, expressed as the year and month by which these ACCESSORIES should be used
(symbol 5.1.4).
The packaging of PRESSURE TRANSDUCER and DOMES that are for single use shall be marked
with symbol 28 in Table D.1 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020.
– 14 – IEC 60601-2-34:2024 © IEC 2024
201.7.9.2.2 Warning and safety notices
Addition:
The instructions for use shall include a warning that defibrillator protection requires the use of
MANUFACTURER specified ACCESSORIES including PRESSURE TRANSDUCERS and adapter cables.
201.7.9.2.9 Operating instructions
Additional subclause:
201.7.9.2.9.101 Additional instructions for use
The operating instructions shall include the following:
a) the INTENDED USE including the environment of use;
b) for ME EQUIPMENT a list of the specified ACCESSORIES such as PRESSURE TRANSDUCER(S) and
DOME(S);
c) for PRESSURE TRANSDUCERS, a list of ME EQUIPMENT that complies with the requirements of
this document when used with these PRESSURE TRANSDUCERS;
PRESSURE TRANSDUCERS and ACCESSORIES, how to
d) descriptions of how to connect the
calibrate and zero the PRESSURE TRANSDUCERS and suggested means for removing
entrapped air from the hydraulic system;
e) recommended frequency of zeroing;
EXAMPLE 1 Every 8 h.
EXAMPLE 2 After moving the patient.
EXAMPLE 3 Following changes in ambient conditions (pressure, temperature).
f) advice to the clinical OPERATOR with regard to the affect changing altitudes and temperatures
OPERATOR
can have on the accuracy of the zero set point and steps that can be taken by the
to identify and resolve this;
g) advice to the clinical OPERATOR whether the PRESSURE TRANSDUCERS or ME EQUIPMENT
incorporates means to protect the PATIENT against burns when used with HIGH-FREQUENCY
(HF) SURGICAL EQUIPMENT;
h) precautions to take when using a defibrillator on a PATIENT; a description of how the
discharge of a defibrillator affects the ME EQUIPMENT;
i) a warning that single-use ACCESSORIES are not to be reused;
j) * if the PRESSURE TRANSDUCER or DOMES, or both, are reusable, information on the
appropriate processes for cleaning, disinfection, packaging and, where appropriate, the
method of sterilization, and any restriction on the number of reuses;
k) if the ME EQUIPMENT has to be connected to other equipment in order to achieve its
INTENDED USE, sufficient details of its characteristics to correctly identify the equipment
necessary for safe operation; especially if, a safety measure or function is not completely
ME EQUIPMENT but instead implemented in an ME SYSTEM, the
integrated into the
ME EQUIPMENT MANUFACTURER shall specify in the ACCOMPANYING DOCUMENTS which
functionality and safety requirements shall be provided by the ME SYSTEM to comply with this
document;
l) precautions to be taken in the event of changes in performance of the tubing,
PRESSURE TRANSDUCER, or cable as a result of ageing and environmental conditions;
m) the warm-up time for the ME EQUIPMENT and PRESSURE TRANSDUCER(S) if greater than 15 s;
n) * advice regarding testing of the ME EQUIPMENT and ACCESSORIES on a daily basis (by the
clinical OPERATOR) and on a scheduled basis (as a service activity). Emphasis should be
placed on how the clinician can test visual and auditory ALARM SIGNALS;
e default settings (e.g. ALARM SETTINGS, modes, and filter);
o) th
p) performance specification (e.g. accuracy, bandwidth, measurement range) of ME EQUIPMENT
including specified PRESSURE TRANSDUCERS and adjustment ranges of all physiological
ALARM SETTINGS (see 208.6.6.2.101);
TECHNICAL ALARM CONDITIONS (see 208.6.1.2.102, 208.6.1.2.103 and
q) explanation of
208.6.1.2.104);
r) the configuration procedure that allows the ALARM SIGNAL inactivation states (ALARM PAUSED,
AUDIO PAUSED, ALARM OFF or AUDIO OFF, ACKNOWLEDGED) or the function ALARM RESET to be
controlled remotely, if provided;
s) simple fault finding methods for troubleshooting problems by which the clinical OPERATOR
can locate problems if the ME EQUIPMENT appears to be functioning incorrectly;
NOTE This relates to simple difficulties, not to technical malfunctions.
t) the subsequent operation of the ME EQUIPMENT after interruption of the SUPPLY MAINS
exceeding 30 s (see 201.11.8);
u) * description of how to disable ALARM SIGNALS for TECHNICAL ALARM CONDITIONS if
PRESSURE TRANSDUCERS or modules are intentionally disconnected by the clinical OPERATOR
(see 208.6.1.2.102);
v) advice on the preferred ALARM SETTINGS and configurations of the ALARM SYSTEM when the
INTENDED USE includes monitoring of PATIENTS that are not continuously attended by a
clinical OPERATOR;
w) precautions to take after spilling of liquids over the INVASIVE BLOOD PRESSURE MONITORING
EQUIPMENT or PRESSURE TRANSDUCER.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 applies, except as follows:
201.8.3 Classification of APPLIED PARTS
Replacement:
The APPLIED PART shall be a TYPE CF APPLIED PART.
201.8.5.5.1 * Defibrillation protection
Addition:
ME EQUIPMENT shall have DEFIBRILLATOR-PROOF APPLIED PARTS.
Addition to item b):
The recovery time after defibrillation shall not exceed 10 s.
Addition to common-mode test to verify a):
Compliance is checked by testing in accordance with Figure 201.101. The requirement is met
when after operation of S , the peak voltage between the points Y1 and Y2 does not exceed
1 V.
In the case of a CATHETER TIP PRESSURE TRANSDUCER, the CATHETER with its
PRESSURE TRANSDUCER is immersed in the saline solution for a length of 75 cm or 90 % of the
actual length of the CATHETER excluding its connector, whichever is the shorter.
– Remove the diaphragm of the DOME.

– 16 – IEC 60601-2-34:2024 © IEC 2024
– Disposable PRESSURE TRANSDUCERS and CATHETER TIP PRESSURE TRANSDUCERS shall be
tested intact and complete.
Repeat the test with the 5 kV supply (V ) reversed.
T
After this test, the ME EQUIPMENT shall meet all requirements and tests of this particular standard
and continue to provide BASIC SAFETY and ESSENTIAL PERFORMANCE.
Following this test, replace the DOME with one that has an intact diaphragm and repeat this test.
Verify that the diaphragm was not punctured during the test.
Compliance is checked (test described in Figure 201.102) by applying air pressure gradually
over about 0,5 s, holding that pressure for about 10 s, and noting the absence of bubbles.
Addition to common-mode test to verify b):
Compliance is checked by applying a test pressure to the PRESSURE TRANSDUCER sufficient to
produce 30 % to 70 % of full-scale deflection (output) at any NOMINAL SENSITIVITY.
ME EQUIPMENT is subjected to a test discharge.
While the pressure is maintained, the
Figure 201.101 is used as the test arrangement under the following conditions:
CLASS I ME EQUIPMENT
– Connect the PROTECTIVE EARTH TERMINAL and any FUNCTIONAL EARTH TERMINAL to the
PROTECTIVE EARTH TERMINAL of the test circuit.
CLASS II ME EQUIPMENT and INTERNALLY POWERED ME EQUIPMENT
ACCESSIBLE PART not connected to FUNCTIONAL EARTH
– Connect foil and any conductive
TERMINAL and any FUNCTIONAL EARTH TERMINAL to the PROTECTIVE EARTH TERMINAL of the test
circuit.
Verify that the deflection (output) returns to within 20 % of the original value (output) within 10 s
after the discharge and remains within these limits for at least a further 30 s.
Compliance is checked (test as described in Figure 201.102) by applying air pressure gradually
over about 0,5 s, holding that pressure for about 10 s, and noting the absence of bubbles.

Key
1 ME EQUIPMENT ENCLOSURE C 1 μF, 5 %
1,2
3 SIGNAL INPUT/OUTPUT PART short circuited or loaded D Small signal silicon diodes
...