EN 60601-2-23:2015

SLOVENSKI STANDARD
01-december-2015
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SIST EN 60601-2-23:2002
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Medical electrical equipment - Part 2-23: Particular requirements for basic safety and
essential performance of transcutaneous partial pressure monitoring equipment
Appareils électromédicaux - Partie 2-23: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de surveillance de la pression partielle
transcutanée
Ta slovenski standard je istoveten z: EN 60601-2-23:2015
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60601-2-23

NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2015
ICS 11.040.55 Supersedes EN 60601-2-23:2000
English Version
Medical electrical equipment - Part 2-23: Particular requirements
for the basic safety and essential performance of transcutaneous
partial pressure monitoring equipment
(IEC 60601-2-23:2011)
Appareils électromédicaux - Partie 2-23: Exigences Medizinische elektrische Geräte - Teil 2-23: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils de surveillance de la pression wesentlichen Leistungsmerkmale von Geräten für die
partielle transcutanée transkutane Partialdrucküberwachung
(IEC 60601-2-23:2011) (IEC 60601-2-23:2011)
This European Standard was approved by CENELEC on 2015-09-15. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-23:2015 E
European foreword
The text of document 62D/885/FDIS, future edition 3 of IEC 60601-2-23, prepared by SC 62D
"Electromedical equipment", of IEC/TC 62 "Electrical equipment in medical practice" was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-23:2015.
The following dates are fixed:
(dop) 2016-06-15
• latest date by which the document has to be implemented at
national level by publication of an identical national
standard or by endorsement
(dow) 2018-09-15
• latest date by which the national standards conflicting with
the document have to be withdrawn

This document supersedes EN 60601-2-23:2000.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral part
of this document.
Endorsement notice
The text of the International Standard IEC 60601-2-23:2011 was approved by CENELEC as a
European Standard without any modification.
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is
available here: www.cenelec.eu.

Annex ZA of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year
Replacement in Annex ZA of EN 60601-1:2006:
IEC 60601-1-2 (mod) 2007 Medical electrical equipment - EN 60601-1-2 2007
Part 1-2: General requirements for basic
- -  + corrigendum Mar. 2010
safety and essential performance -
Collateral standard: Electromagnetic
compatibility - Requirements and tests
IEC 60601-1-8 2006 Medical electrical equipment - EN 60601-1-8 2007
Part 1-8: General requirements for basic
- -  + corrigendum Mar. 2010
safety and essential performance -
Collateral Standard: General
requirements, tests and guidance for
alarm systems in medical electrical
equipment and medical electrical
systems
Addition to Annex ZA of EN 60601-1:2006:
EN 60601-2-49 2015
IEC 60601-2-49 2011 Medical electrical equipment -
Part 2-49: Particular requirements for the
basic safety and essential performance
of multifunction patient monitoring
equipment
Annex ZZ
(informative)
Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and within its scope the Standard covers all
relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993
concerning medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EU Directives can be applied to the products falling within
the scope of this standard.
IEC 60601-2-23 ®
Edition 3.0 2011-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-23: Particular requirements for the basic safety and essential performance
of transcutaneous partial pressure monitoring equipment

Appareils électromédicaux –
Partie 2-23: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de surveillance de la pression partielle transcutanée

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX X
ICS 11.040.55 ISBN 978-2-88912-370-4

– 2 – 60601-2-23 © IEC:2011
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 . 11
201.5 General requirements for testing of ME EQUIPMENT . 11
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents . 12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 13
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14
201.10 Protection against unwanted and excessive radiation HAZARDS . 14
201.11 Protection against excessive temperatures and other HAZARDS . 14
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 18
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 . 23
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 24
202 Electromagnetic compatibility – Requirements and tests . 24
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems . 28
Annexes . 34
Annex AA (informative) Particular guidance and rationale . 35
Annex BB (informative) Alarm diagrams of Clause 208/IEC 60601-1-8:2006 . 43
Index of defined terms used in this particular standard. 46

Figure 201.101 – TRANSDUCER cable strain relief test . 14
Figure 201.102 – Foam block test (see 201.11.1.2.2.104 and 201.11.1.2.2.105) . 15
Figure 201.103 – Linearity and hysteresis test set-up – Gas mix chamber, assembled . 20
Figure 201.104 – Linearity and hysteresis test set-up – Gas mix chamber,
manufacturing dimensions . 21
Figure 201.105 – Linearity and hysteresis test set-up – Gas mix chamber, dimensions
of hose connector . 22
Figure 202.101 – Set-up for radiated and conducted EMISSIONS testing according to
202.6.1.1.2 a) . 25
Figure 202.102 – Set-up for radiated immunity test according to 202.6.2.3.2 . 27
Figure BB.1 – NON-LATCHING ALARM SIGNALS without ALARM RESET . 43
Figure BB.2 – NON-LATCHING ALARM SIGNALS with ALARM RESET . 43
Figure BB.3 – LATCHING ALARM SIGNALS with ALARM RESET . 44
Figure BB.4 – Two ALARM CONDITIONS with ALARM RESET . 44

60601-2-23 © IEC:2011 – 3 –
Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements . 11
Table 201.102 – Required readings and tolerances . 19
Table 201.103 – Calibration test gases . 19
Table 208.101 – ALARM CONDITION priorities . 29
Table 208.102 – Characteristics of the burst of auditory ALARM SIGNALS . 30

– 4 – 60601-2-23 © IEC:2011
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-23: Particular requirements for the basic safety and
essential performance of transcutaneous partial
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
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.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between 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
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
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
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
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) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International standard IEC 60601-2-23 has been prepared by IEC subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This third edition cancels and replaces the second edition published in 1999 and constitutes a
technical revision. This edition of IEC 60601-2-23 was revised to align structurally with the
2005 edition of IEC 60601-1.
60601-2-23 © IEC:2011 – 5 –
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/885/FDIS 62D/907/RVD
Full information on the voting for the approval of this particular 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 2.
In this standard, 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 THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, 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 standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “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 series, published under the general title Medical electrical
equipment, can be found on the IEC website.

– 6 – 60601-2-23 © IEC:2011
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
60601-2-23 © IEC:2011 – 7 –
INTRODUCTION
This particular standard concerns the BASIC SAFETY and ESSENTIAL PERFORMANCE of
TRANSCUTANEOUS PARTIAL PRESSURE MONITORING EQUIPMENT. It amends and supplements
IEC 60601-1 (third edition, 2005): Medical electrical equipment – Part 1: General
requirements for basic safety and essential performance, hereinafter referred to as the
general standard.
The aim of this third edition is to bring this particular standard up to date with reference to the
third edition of the general standard through reformatting and technical changes.
The requirements of this particular standard take priority over those of the general standard.
A “General guidance and rationale” for the more important requirements of this particular
standard 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 Standard.
– 8 – 60601-2-23 © IEC:2011
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-23: Particular requirements for the basic safety and
essential performance of transcutaneous partial
pressure monitoring equipment
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
TRANSCUTANEOUS PARTIAL PRESSURE MONITORING EQUIPMENT as defined in 201.3.63 and
ME EQUIPMENT, whether this ME EQUIPMENT is stand alone or part of a
hereinafter referred to as
system.
This standard applies to transcutaneous monitors used with adults, children and neonates,
and it includes the use of these devices in foetal monitoring during birth.
This standard does not apply to haemoglobin saturation oximeters or to devices applied to
surfaces of the body other than the skin (for example conjunctiva, mucosa).
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 standard are not covered by specific requirements in this standard except in
7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the General Standard.
201.1.2 Object
Replacement:
The object of this particular standard is to establish BASIC SAFETY and
ESSENTIAL PERFORMANCE requirements for TRANSCUTANEOUS PARTIAL 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 the general standard and Clause 201.2 of this particular standard.
—————————
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance

60601-2-23 © IEC:2011 – 9 –
IEC 60601-1-2:2007 and IEC 60601-1-8:2006 apply as modified in Clauses 202 and 208
respectively. IEC 60601-1-3 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 the general standard 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 the general standard.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
of Clause 1 of the general standard) 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 60601-1-2 collateral standard,
203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3 collateral
standard, etc.). The changes to the text of the general standard are specified by the use of
the following words:
"Replacement" means that the clause or subclause of the general standard 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
the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard 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 the general standard are
numbered starting from 201.101. However, due to the fact that definitions in the general
standard are numbered 3.1 through 3.139, additional definitions in this standard 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, 203 for IEC 60601-1-3, etc.
The term "this standard" is used to make reference to the general standard, 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 the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.

– 10 – 60601-2-23 © IEC:2011
201.2 Normative references
Clause 2 of the general standard applies, except as follows:
Replacement:
IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests
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
Addition:
IEC 60601-2-49:2011, Medical electrical equipment - Part 2-49: Particular requirements for

the basic safety and essential performance of multifunction patient monitoring equipment
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005
apply, except as follows:
201.3.8
APPLIED PART
Addition:
TRANSDUCER and its connecting lead
Replacement:
201.3.63
TRANSCUTANEOUS PARTIAL PRESSURE MONITORING EQUIPMENT
ME EQUIPMENT
device and associated TRANSDUCERS for the monitoring of partial pressures of oxygen and/or
carbon dioxide at the skin surface
Additional definitions:
201.3.201
APPLIED PART INTERFACE
that portion of the APPLIED PART intended to come into contact with the PATIENT'S skin
201.3.202
PATIENT CABLE
insulated wire(s) between the TRANSDUCER and the ME EQUIPMENT
201.3.203
SET TEMPERATURE
desired APPLIED PART INTERFACE temperature
201.3.204
TEMPERATURE LIMITER
means of limiting the temperature of the APPLIED PART INTERFACE

60601-2-23 © IEC:2011 – 11 –
201.3.205
TRANSDUCER
device for converting the partial pressure of a gas into a signal for monitoring or recording
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.7 SINGLE FAULT CONDITION for ME EQUIPMENT
Addition:
SINGLE FAULT CONDITION includes any single failure in the ME EQUIPMENT resulting in a transfer
of energy to the APPLIED PART which is greater than that necessary to maintain the SET
TEMPERATURE value.
Additional subclause:
201.4.101 Additional ESSENTIAL PERFORMANCE requirements
Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in
Table 201.101.
Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements
Requirement Subclause
Non-linearity and hysteresis 201.12.1.101.1
Time to alarm for pO and pCO ALARM CONDITIONS 208.6.6.1.103
2 2
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.4 Other conditions
Addition:
Unless otherwise stated, tests shall be carried out with the ACCESSORIES and the recording
materials specified by the MANUFACTURER.
For ME EQUIPMENT with an INTERNAL ELECTRICAL POWER SOURCE, if the test result is affected by
the INTERNAL ELECTRICAL POWER SOURCE voltage, then the test shall be performed using the
least favourable INTERNAL ELECTRICAL POWER SOURCE voltage specified by the MANUFACTURER.
If necessary for the purpose of conducting the test, an external battery or d.c. power supply
may be used to provide the necessary 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 %
– 12 – 60601-2-23 © IEC:2011
201.5.8 * Sequence of tests
Amendment:
If applicable, the tests specified in 8.5.5 of the general standard shall be carried out prior to
the LEAKAGE CURRENT and dielectric strength tests described in subclauses 8.7 and 8.8 of the
general standard.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies, except as follows:
201.6.2 * Protection against electric shock
Replacement of the last paragraph:
PPLIED PARTS shall be classified as TYPE BF APPLIED PARTS or TYPE CF APPLIED PARTS
A
(see 7.2.10 and 8.3 b) of the general standard).
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 the general standard applies, except as follows:
201.7.9.2 Instructions for use
Additional subclause:
201.7.9.2.101 Additional instructions for use
The operating instructions shall include the following:
a) the INTENDED USE including the environment of use;
b) procedures affecting the safety of operation, in particular the temperature selection and
duration of monitoring time, on that particular site at that temperature, based upon
clinical evaluation of the PATIENT, for example age, weight and physiological condition;
c) instructions for connecting a POTENTIAL EQUALIZATION CONDUCTOR, if applicable;
d) the choice and application of the specified TRANSDUCERS and ACCESSORIES;
e) * use of the ME EQUIPMENT with high frequency surgical ME EQUIPMENT, to avoid burns to
the PATIENT and damage to the TRANSDUCER; a statement, if applicable, that the
TRANSDUCER is to be removed from the PATIENT during the high frequency surgical
procedures;
f) precautions to take when using a defibrillator on a PATIENT; a description how the
discharge of a defibrillator affects the ME EQUIPMENT and the TRANSDUCER; a warning that
defibrillator protection requires use of MANUFACTURER specified ACCESSORIES including
TRANSDUCERS and PATIENT CABLES, if applicable. The specification (or type-number) of
such ACCESSORIES is to be disclosed;
g) a statement to the effect: "This equipment is not a blood gas device";
h) * for TRANSDUCERS and cables, particularly disposable TRANSDUCERS, its MANUFACTURER
shall state the recommended usable safe life;

60601-2-23 © IEC:2011 – 13 –
i) * proper handling of TRANSDUCERS and their ACCESSORIES to avoid damage to these
delicate components, thereby extending their useful life. In addition, these instructions
shall refer, in particular, to the TRANSDUCER to cable connection and provide information
on the measures that the clinical OPERATOR should adopt to prevent damage to this
connection;
j) information on the warm-up time for the TRANSDUCER and ME EQUIPMENT;
k) the drift per hour for O and CO and recommendations for recalibration;
2 2
l) any interfering gases or vapours that are known to cause deviation outside the range
specified;
m) the maximum time required for the ME EQUIPMENT to display a 10 % to 90 % response to
a step change between test gases 1 and 2 in either direction;
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 may test visual and auditory ALARM SIGNALS;
o) 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 operator difficulties, not to technical malfunctions;
p) the subsequent operation of the ME EQUIPMENT after interruption of SUPPLY MAINS
exceeding 30 s (see 201.11.8);
q) * description of how to disable ALARM SIGNALS for TECHNICAL ALARM CONDITIONS if the
TRANSDUCER or module is intentionally disconnected by the clinical OPERATOR;
r) the configuration procedure that allows the ALARM SIGNAL inactivation states
ALARM PAUSED, AUDIO PAUSED, ALARM OFF or AUDIO OFF) or the function ALARM RESET to
(
be controlled remotely (see 208.6.11.101), if provided;
s) advice on the preferred ALARM SETTINGS and configurations of the ALARM SYSTEM when
its INTENDED USE includes the monitoring of PATIENTS that are not continuously attended
OPERATOR;
by a clinical
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies, except as follows:
Additional subclause:
201.8.101 * TRANSDUCERS and cables
Re-usable TRANSDUCERS and cables shall be provided with strain relief at the
cable/TRANSDUCER junction capable of withstanding the tensile forces occurring during
NORMAL USE.
After the test, neither the insulation of the cable nor the strain relief shall show any
DEGRADATION and the TRANSDUCER shall function normally.
Compliance is checked by the following test:
Suddenly apply a load of 5 N to the cable in any direction within the conic sectional space
having an apex angle of 90°, with said apex coinciding with the point of exit of the cable from
the TRANSDUCER, and limited by a flat plane coinciding with the intended plane of application
of the TRANSDUCER to the PATIENT.
Repeat this test five times at different angles of the cable from the TRANSDUCER; choose these
angles being at random within the conic section (see Figure 201.101).

– 14 – 60601-2-23 © IEC:2011
90°
IEC  376/11
Figure 201.101 – TRANSDUCER cable strain relief test
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
Clause 9 of the general standard applies.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies.
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard applies, except as follows:
201.11.1.2 Temperature of APPLIED PARTS
201.11.1.2.2 * APPLIED PARTS not intended to supply heat to a PATIENT
Replacement for the first sentence:
In NORMAL CONDITION the maximum temperature of the APPLIED PART of the TRANSDUCER shall
not exceed 45 ºC. The maximum temperature shall not exceed 45,6 ºC for 20 s in any period
of 30 min.
NOTE 45,6 °C is the maximum temperature of the APPLIED PART (45°C) plus an allowed overshoot of 0,6 °C.
Addition:
201.11.1.2.2.101 Heater in the APPLIED PART
ME EQUIPMENT having a heater in the APPLIED PART shall be provided with means for
controlling the temperature of the APPLIED PART.
Compliance is checked by inspection.
201.11.1.2.2.102 Indication of SET TEMPERATURE
Means shall also be provided for indicating numerically the SET TEMPERATURE (during
temperature setting and on request of the clinical OPERATOR).
Compliance is checked by inspection.

60601-2-23 © IEC:2011 – 15 –
201.11.1.2.2.103 SET TEMPERATURE
The SET TEMPERATURE shall not exceed 45 °C.
Compliance is checked by inspection.
201.11.1.2.2.104 Temperature overshoot
In NORMAL CONDITION the temperature of the APPLIED PART INTERFACE shall not exceed the
SET TEMPERATURE by more than 0,6 °C for more than a total of 20 s, in any period of 30 min
after the settling period recommended by the manufacturer (see also 201.11.1.2.2).
Compliance is checked by measurement of the APPLIED PART INTERFACE temperature.
Procedure:
Plug in the TRANSDUCER; place the TRANSDUCER over the thermocouple in test fixture of
Figure 201.102; apply force to compress foam to half thickness; take readings from the
thermocouple.
With the TRANSDUCER mounted as in Figure 201.102, measure the temperature of the
APPLIED PART INTERFACE continuously for any 30 min in the 4 h after the ME EQUIPMENT is
energised, taking into account the settling period.
Operation shall be as in the instructions for use, with any recommended contact medium.

IEC  377/11
Key
1 Transducer applied to foam by some means to compress foam to half its original thickness
2 TRANSDUCER
Thermocouple approximately 0,076 mm in diameter, chromel-alumel type K (bare insulation) or
equivalent, connected to electronic thermometer or digital multimeter
4 Foam block, density approximately 30 kg/m , cross-linked open cell polyurethane or equivalent
Figure 201.102 – Foam block test (see 201.11.1.2.2.104 and 201.11.1.2.2.105)
This is a representative test, equivalent methods may be used.
Materials required for the test:
a) digital thermometer;
– 16 – 60601-2-23 © IEC:2011
b) chromel-alumel type K thermocouple, reproducible to 0,1°C (measurement uncertainty
shall be established and quoted for each ME EQUIPMENT certification);
c) means to apply force to the TRANSDUCER;
d) foam insulation material.
201.11.1.2.2.105 Temperature limiter
ME EQUIPMENT having a heater in the APPLIED PART shall be provided with a
TEMPERATURE LIMITER for the APPLIED PART INTERFACE which cannot be adjusted by the clinical
OPERATOR and which functions independently of the normal temperature control means.
In SINGLE FAULT CONDITION (as specified in subclause 4.7), this TEMPERATURE LIMITER shall
prevent the temperature of the APPLIED PART INTERFACE from exceeding 45,6 °C for more than
a total of 20 s in a 30 min period but never exceeding 46°C.
Compliance is checked by inspection for the presence of a TEMPERATURE LIMITER and by
introducing a SINGLE FAULT CONDITION as described in 201.4.7, then by measuring the
temperature of the APPLIED PART when mounted as in Figure 201.102. After a stabilization
period of 20 min, the SINGLE FAULT CONDITION is introduced and the temperature of the APPLIED
PART INTERFACE is measured continuously for a period of 30 min.
For ME EQUIPMENT having an INTERNAL ELECTRICAL POWER SOURCE, the requirements in
subclauses 201.11.1.2.2 to 201.11.1.2.2.105 shall be met for any state of discharge of the
INTERNAL ELECTRICAL POWER SOURCE.
Compliance is checked by inspection.
201.11.1.2.2.106 * Indication of temperature deviation in SINGLE FAULT CONDITION
When the temperature of the APPLIED PART INTERFACE exceeds the SET TEMPERATURE by more
than 0,6 °C in NORMAL CONDITION a TECHNICAL ALARM CONDITION shall be indicated.
Compliance is checked by causing the temperature of the APPLIED PART INTERFACE to exceed
the SET TEMPERATURE by more than 0,6 °C and verifying that a TECHNICAL ALARM CONDITION
occurs.
201.11.1.2.2.107 Timer indicating an elapsed time
ME EQUIPMENT shall be provided with a clinical OPERATOR adjustable timer that initiates a
TECHNICAL ALARM CONDITION when the adjusted time has been elapsed. This timer may also
de-energise the TRANSDUCER. The elapsed time shall be visually indicated.
Compliance is checked by inspection and functional test.
NOTE The purpose of this timer is to inform the clinical OPERATOR that the TRANSDUCER has to be re-positioned or
that the heating of the TRANSDUCER has been switched off to prevent burns.
201.11.6.5 * Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS
Addition:
PORTABLE/TRANSPORTABLE ME EQUIPMENT or parts of the ME EQUIPMENT separable while
remaining functioning shall be constructed so that, in the event of spillage of liquids
(accidental wetting) no HAZARDOUS SITUATION results from the ingress of liquids.
The ME EQUIPMENT shall meet the dielectric strength requirements specified in 8.8.3 of the
general standard and shall comply with the requirements of this particular standard.

60601-2-23 © IEC:2011 – 17 –
Compliance is checked by the following test:
Place the PORTABLE/TRANSPORTABLE ME EQUIPMENT or parts of the ME EQUIPMENT in the least
favourable position of NORMAL USE. Subject the ME EQUIPMENT for 30 s to an artificial rainfall of
3 mm/min falling vertically from a height of 0,5 m above the top of the ME EQUIPMENT.
A test apparatus is shown in Figure 3 of IEC 60529.
An intercepting device may be used to determine the duration of the test.
Immediately after 30 s exposure, remove any visible moisture on the ENCLOSURE.
Immediately after the above test, verify (by inspection) that any water that entered the
ME EQUIPMENT cannot adversely affect the BASIC SAFETY of the ME EQUIPMENT. Verify that the
ME EQUIPMENT meets the relevant dielectric strength test (8.8.3 of the general standard) and
does not result in a HAZARDOUS SITUATION.
After this test, verify that the ME EQUIPMENT complies with the requirements of this particular
standard.
TRANSDUCERS shall be protected against the ingress of liquids. After the following test, the
ME EQUIPMENT shall function as described in the ACCOMPANYING DOCUMENTS.
Compliance is checked by immersing the TRANSDUCER during normal operation for 1 h. At
least 10 cm of its lead wire is immersed 5 cm deep in water that is at the SET TEMPERATURE
± 0,6 °C.
SUPPLY MAINS to ME EQUIPMENT
201.11.8 * Interruption of the power supply /
Addition:
If the SUPPLY MAINS to the ME EQUIPMENT in which there is no
INTERNAL ELECTRICAL POWER SOURCE is interrupted for 30 s or less and the TRANSDUCER is
energised, either
a) the mode of operation and all OPERATOR settings shall not be changed, or
b) the TRANSDUCER shall be de-energised and any indication of partial pressure shall be
cancelled. This de-energised state shall be indicated by a TECHNICAL ALARM CONDITION.
This TECHNICAL ALARM CONDITION shall be indicated by LATCHING ALARM SIGNALS.
NOTE The ME EQUIPMENT does not have to be operating during the interruption of the SUPPLY MAINS.
Compliance is checked by observing the ME EQUIPMENT operating mode and interrupting the
SUPPLY MAINS for a period of 10 s to 30 s, any ON-OFF switch on the ME EQUIPMENT being left
in the "ON" position.
If the SUPPLY MAINS to the ME EQUIPMENT in which there is no INTERNAL ELECTRICAL POWER
SOURCE is int
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