IEC 60601-2-23:1999

INTERNATIONAL IEC
STANDARD
60601-2-23
Second edition
1999-12
Medical electrical equipment –
Part 2-23:
Particular requirements for the safety,
including essential performance,
of transcutaneous partial pressure monitoring
equipment
Appareils électromédicaux –
Partie 2-23:
Règles particulières de sécurité et performances essentielles
des appareils de surveillance de la pression partielle
transcutanée
Reference number
Numbering
As from 1 January 1997 all IEC publications are issued with a designation in the
60000 series.
Consolidated publications
Consolidated versions of some IEC publications including amendments are
available. 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.
Validity of this publication
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 the date of the reconfirmation of the publication is available
in the IEC catalogue.
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 to be found at the following IEC sources:
• IEC web site*
•
Catalogue of IEC publications
Published yearly with regular updates
(On-line catalogue)*
• IEC Bulletin
Available both at the IEC web site* and as a printed periodical
Terminology, graphical and letter symbols
For general terminology, readers are referred to IEC 60050: International
Electrotechnical Vocabulary (IEV).
For graphical symbols, and letter symbols and signs approved by the IEC for
general use, readers are referred to publications IEC 60027: Letter symbols to be
used in electrical technology, IEC 60417: Graphical symbols for use on equipment.
Index, survey and compilation of the single sheets and IEC 60617: Graphical symbols
for diagrams.
* See web site address on title page.

INTERNATIONAL IEC
STANDARD
60601-2-23
Second edition
1999-12
Medical electrical equipment –
Part 2-23:
Particular requirements for the safety,
including essential performance,
of transcutaneous partial pressure monitoring
equipment
Appareils électromédicaux –
Partie 2-23:
Règles particulières de sécurité et performances essentielles
des appareils de surveillance de la pression partielle
transcutanée
 IEC 1999  Copyright - all rights reserved
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 the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: +41 22 919 0300 e-mail: inmail@iec.ch IEC web site http://www.iec.ch
Commission Electrotechnique Internationale
PRICE CODE
V
International Electrotechnical Commission
For price, see current catalogue

– 2 – 60601-2-23 © IEC:1999(E)
CONTENTS
Page
FOREWORD . 4
SECTION ONE – GENERAL
1 Scope and object. 6
2 Terminology and definitions. 7
3 General requirements. 9
4 General requirements for tests . 9
5 Classification. 9
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. 11
20 Dielectric strength . 11
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength . 11
SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
*36 Electromagnetic compatibility . 12
SECTION SIX – PROTECTION AGAINST THE HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
42 Excessive temperatures . 15
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization,
disinfection and compatibility. 16
49 Interruption of the power supply. 16
SECTION EIGHT – ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
51 Protection against hazardous output. 17
SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions . 23
SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly . 23
57 MAINS PARTS, components and layout . 24

60601-2-23 © IEC:1999(E) – 3 –
Figure 101 – TRANSDUCER cable strain relief test. 24
Figure 102 – Foam block test . 25
Figure 103a – Linearity and hysteresis test set-up – Gas mix chamber, assembled . 26
Figure 103b – Linearity and hysteresis test set-up – Gas mix chamber,
manufacturing dimensions. 27
Figure 103c – Linearity and hysteresis test set-up – Gas mix chamber, dimensions
of hose connector. 28
Figure 104 – EMC test set-up for conducted and radiated emission,
and radiated immunity test . 29
Appendix L (normative) References – Publications mentioned in this standard. 30
Annex AA (informative) General guidance and rationale. 31

– 4 – 60601-2-23 © IEC:1999(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION
––––––––––––
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-23: Particular requirements for the safety,
including essential performance, of transcutaneous partial
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 object of the 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, the IEC publishes International Standards. 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. 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 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 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 guides 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 60601-2-23 has been prepared by subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This second edition of IEC 60601-2-23 cancels and replaces the first edition published
in 1993, and constitutes a technical revision. This second edition also covers the scope of
IEC 60601-3-1 published in 1996.
The text of this standard is based on the following documents:
FDIS Report on voting
62D/335/FDIS 62D/345/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 3.
A bilingual version of this standard may be issued at a later date.

60601-2-23 © IEC:1999(E) – 5 –
Appendix L forms an integral part of this Standard.
Annex AA is for information only.
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, instructions, general statements, exceptions and references: in smaller roman
type;
– test specifications: in italic type;
– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD IEC 60601-1 OR THIS PARTICULAR
STANDARD: SMALL CAPITALS.
The committee has decided that this publication remains valid until 2005. At this date, in
accordance with the committee’s decision, the publication will be
reconfirmed;
withdrawn;
replaced by a revised edition, or
amended.
– 6 – 60601-2-23 © IEC:1999(E)
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-23: Particular requirements for the safety,
including essential performance, of transcutaneous partial
pressure monitoring equipment
SECTION ONE – GENERAL
The clauses and subclauses of the General Standard apply except as follows:
1 Scope and object
This clause of the General Standard applies except as follows:
*1.1 Scope
Addition:
This Particular Standard specifies requirements for the safety, including essential
performance, of TRANSCUTANEOUS PARTIAL PRESSURE MONITORING EQUIPMENT, as defined
in 2.101 and hereinafter referred to as EQUIPMENT, whether this EQUIPMENT is stand alone or
part of a system.
It applies to transcutaneous monitors used with adults, children and neonates, and it includes
the use of these devices in foetal monitoring during birth.
It does not apply to haemoglobin saturation oximeters or to devices applied to surfaces of the
body other than the skin (for example conjunctiva, mucosa).
1.2 Object
Replacement:
The object of this Particular Standard is to establish particular requirements for the safety,
including essential performance, of TRANSCUTANEOUS PARTIAL PRESSURE MONITORING
EQUIPMENT as defined in 2.101.
1.3 Particular standards
Addition:
This Particular Standard amends and supplements a set of IEC publications consisting of:
IEC 60601-1:1988, Medical electrical equipment – Part 1: General requirements for safety,
amendment 1, amendment 2,
IEC 60601-1-2:1993, Medical electrical equipment – Part 1: General requirements for safety –
2. Collateral Standard: Electromagnetic compatibility – Requirements and tests and
IEC 60601-1-4:1996, Medical electrical equipment – Part 1: General requirements for safety –
4. Collateral Standard: Programmable electrical medical systems.

60601-2-23 © IEC:1999(E) – 7 –
For brevity, IEC 60601-1 is referred to, in this Particular Standard, either as the "General
Standard" or as the "General Requirement(s)".
The term "this Standard" covers the Particular Standard used together with the General
Standard and any Collateral Standards.
The numbering of sections, clauses and subclauses of this Particular Standard corresponds
with that of the General Standard. 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 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.
"Amendment" means that the clause or subclause of the General Standard is amended as
indicated by the text of this Particular Standard.
Subclauses or figures which are additional to those of the General Standard are numbered
starting from 101, additional annexes are lettered AA, BB, etc., and any additional items aa),
bb), etc.
Clauses and subclauses for which there is a rationale are marked with an asterisk*. These
rationales can be found in an informative annex AA. Annex AA should be used in determining
the relevance of the requirements addressed, but should never be used to establish additional
test requirements.
Where there is no corresponding section, clause or subclause in this Particular Standard, the
section, clause or subclause of the General Standard or Collateral Standard applies without
modification.
Where it is intended that any part of the General Standard or Collateral Standard, although
possibly relevant, is not to be applied, a statement to that effect is given in this Particular
Standard.
A requirement of this Particular Standard replacing or modifying requirements of the General
Standard or Collateral Standard takes precedence over the corresponding General Requirement(s).
2 Terminology and definitions
This clause of the General Standard applies except as follows:
2.1.5
APPLIED PART
Replacement:
RANSDUCER
T and its connecting lead.
Additional definitions:
2.101
TRANSCUTANEOUS PARTIAL PRESSURE MONITORING EQUIPMENT (EQUIPMENT)
device and associated TRANSDUCERS for the monitoring of partial pressures of oxygen and/or
carbon dioxide at the skin surface

– 8 – 60601-2-23 © IEC:1999(E)
2.102
TRANSDUCER
device for converting the partial pressure of a gas into a signal for monitoring or recording
2.103
TEMPERATURE LIMITER
means of limiting the temperature of the APPLIED PART INTERFACE
2.104
SET TEMPERATURE
desired applied part interface temperature
2.105
WARNING SIGNAL
means of signalling a predetermined state of a physiological parameter or EQUIPMENT
2.106
APPLIED PART INTERFACE
that portion of the APPLIED PART intended to come into contact with the PATIENT's skin
2.2.102
MULTIFUNCTION PATIENT MONITORING EQUIPMENT
stationary or mobile EQUIPMENT powered by an electrical power source and including one or
more physiological monitoring units designed to collect information from a PATIENT, process it
and generate ALARMS
2.12.101
ALARM
signal which indicates abnormal events occurring to the PATIENT or EQUIPMENT
2.12.102
PHYSIOLOGICAL ALARM
signal which either indicates that a monitored physiological parameter is out of the specified
limits or indicates an abnormal PATIENT condition
2.12.103
TECHNICAL ALARM
signal which indicates that an EQUIPMENT is not capable of accurately monitoring or no longer
monitors the PATIENT'S condition
2.12.104
SILENCING
stopping an auditory ALARM manifestation by manual action
2.12.105
SILENCING/RESET
stopping a visual and/or auditory ALARM manifestation and re-enabling the equipment
response to an abnormal PATIENT condition
2.12.106
INHIBITION
disabling, or SILENCING and disabling, an ALARM until intentionally revoked

60601-2-23 © IEC:1999(E) – 9 –
2.12.107
SUSPENSION
disabling, or SILENCING and disabling, an ALARM temporarily
2.12.108
LATCHED ALARM
an ALARM, the visual and auditory manifestation of which does not stop when the parameter
returns to a value which no longer exceeds the ALARM limit or when the abnormal PATIENT
condition does not exist any longer
2.12.109
NON-LATCHED ALARM
an ALARM, the visual and auditory manifestation of which stops when the parameter returns to
a value which no longer exceeds the ALARM limit or when the abnormal PATIENT condition does
not exist any longer
3 General requirements
This clause of the General Standard applies except as follows:
3.6 SINGLE FAULT CONDITION
Additional item:
aa) Any single failure in the EQUIPMENT resulting in a transfer of energy to the APPLIED PART
which is greater than that necessary to maintain the SET TEMPERATURE value.
4 General requirements for tests
This clause of the General Standard applies except as follows:
4.11 Sequence
Amendment:
The tests called for in item h) of clause 17 shall be performed prior to the LEAKAGE CURRENT
and dielectric strength tests of clauses C.24 and C.25 of the General Standard.
5 Classification
This clause of the General Standard applies except as follows:
*5.2 According to the degree of protection against electric shock:
Amendment:
Delete TYPE B APPLIED PART.
– 10 – 60601-2-23 © IEC:1999(E)
5.6 According to the mode of operation:
Amendment:
Delete all but CONTINUOUS OPERATION.
6 Identification, marking and documents
This clause of the General Standard applies except as follows:
6.8.2 Instructions for use
Additional item:
aa) Supplementary instructions for use
Advice shall be given on the following:
1) 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.
2) Choice of TRANSDUCERS and ACCESSORIES, where the use of other TRANSDUCERS and
ACCESSORIES could degrade the safety of the EQUIPMENT.
*3) Use of the EQUIPMENT with high frequency surgical EQUIPMENT, to avoid burns to the
PATIENT and damage to the TRANSDUCER, including, if applicable, a statement that the
TRANSDUCER shall be removed from the PATIENT during the high frequency surgical
procedures.
4) The ACCOMPANYING DOCUMENTS shall contain information on protection against the effects
of defibrillation.
EQUIPMENT
5) Those parts of the which are protected against the effects of a discharge of a
cardiac defibrillator.
6) Any precautions to be taken when a defibrillator is used on a PATIENT and information on
any effects of a discharge of a cardiac defibrillator on the EQUIPMENT and the
TRANSDUCER.
7) The ACCOMPANYING DOCUMENTS shall contain a statement to the effect: "This EQUIPMENT is
not a blood gas device".
*8) For TRANSDUCERS and cables, particularly disposable TRANSDUCERS, the manufacturer
shall state the recommended usable safe life.
*9) 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 USER should adopt to prevent damage to this connection.
10) If the EQUIPMENT can be connected to other medical or non-medical EQUIPMENT, this
combination shall comply with IEC 60601-1-1.
11) Information on the warm-up time for the TRANSDUCER and EQUIPMENT.
SECTION TWO – ENVIRONMENTAL CONDITIONS
The clauses and subclauses of this section of the General Standard apply.

60601-2-23 © IEC:1999(E) – 11 –
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
The clauses and subclauses of this section of the General Standard apply except as follows:
14 Requirements related to classification
This clause of the General Standard applies except as follows:
*14.6 TYPES B, BF and CF APPLIED PARTS
Replacement:
The APPLIED PART shall be TYPE BF or TYPE CF.
17 Separation
This clause of the General Standard applies except as follows:
Item h)
Addition:
For EQUIPMENT specified as being protected against the effects of a cardiac defibrillator
discharge, item h) of the General Standard applies (as does the specified test voltage of 5 kV)
with the following addition:
After the test, and following a recovery period of 1 min, the EQUIPMENT shall be capable of
meeting all the requirements of this Particular Standard.
20 Dielectric strength
This clause of the General Standard applies except as follows:
*20.2 Requirements for EQUIPMENT with an APPLIED PART
Amendment:
B-b does not apply.
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
The clauses and subclauses of this section of the General Standard apply except as follows:
21 Mechanical strength
This clause of the General Standard applies except as follows:
*21.1 TRANSDUCERS and cables
TRANSDUCERS
Re-usable and cables shall be provided with a strain relief at the
cable/TRANSDUCER junction, capable of withstanding the tensile forces occurring during
NORMAL USE.
– 12 – 60601-2-23 © IEC:1999(E)
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.
The cable shall be subjected to a suddenly applied load of 5 N in any direction within the
conic sectional space having an apex angle of 90°, with the 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.
The test shall be repeated five times at different angles of the cable from the TRANSDUCER,
these angles being chosen at random within the conic section described (see figure 101).
*21.5 Mechanical strength – Free fall
Addition:
TRANSDUCERS shall not present a SAFETY HAZARD as a result of a free fall from a height of 1 m
on to a hard surface.
After the test, and after remembraning and calibration according to the ACCOMPANYING
DOCUMENTS, all the thermal and electrical requirements of this Particular Standard shall be
satisfied.
Compliance is checked by the following test.
The unpowered sample to be tested is allowed to fall freely once from each of three different
starting positions, from a height of 1 m on to a 50 mm thick hardwood board (for example
hardwood with a density greater than or equal to 600 kg/m ), which lies flat on a rigid base
(for example a concrete floor).
SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
The clauses and subclauses of this section of the General Standard apply except as follows:
*36 Electromagnetic compatibility
The EQUIPMENT is not a LIFE-SUPPORTING EQUIPMENT as defined in 2.201 of IEC 60601-1-2.
The Collateral Standard IEC 60601-1-2 applies except as follows:
36.201 Emissions
36.201.1.1
Replacement:
The EQUIPMENT shall comply with the requirements of CISPR 11, Group 1, Class A or B
depending on intended use.
60601-2-23 © IEC:1999(E) – 13 –
36.201.1.7
Replacement:
The EQUIPMENT shall be tested with the TRANSDUCER specified by the manufacturer.
The SIGNAL INPUT and SIGNAL OUTPUT cables (if applicable) shall be attached to the EQUIPMENT
during the test (see 36.202.2.2a) and figure 104 of this Particular Standard).
36.202 Immunity
Addition to paragraph 4:
The EQUIPMENT shall not change its operating state, shall not lose or change any stored data
and, for pO in the range 40 to 100 mm Hg and for pCO in the range 30 to 60 mm Hg, the
2 2
change in the accuracy of the partial pressure reading shall not exceed ±6 mm Hg.
Compliance is checked by the following test.
– Set up the EQUIPMENT and TRANSDUCER as outlined in figure 104.
– Calibrate the TRANSDUCER according to the ACCOMPANYING DOCUMENTS.
– Expose the EQUIPMENT to the specified disturbances (radio frequency, transients,
magnetic) at any NOMINAL sensitivity.
36.202.1 Electrostatic discharge
Replacement of the second sentence:
A level of 6 kV shall apply for contact discharge to conductive ACCESSIBLE PARTS and coupling
planes.
Addition:
The EQUIPMENT shall return to its previous operating mode within 1 min, without loss of any
stored data.
36.202.2 Radiated radio-frequency electromagnetic fields
36.202.2.1.a)
Replacement:
The EQUIPMENT shall comply with IEC 61000-4-3
36.202.2.1 d)
Replacement:
The IMMUNITY level for this EQUIPMENT shall be 3 V/m.
The EQUIPMENT shall not change its operating state, shall not lose or change any stored data
and, for pO in the range 40 to 100 mm Hg and for pCO in the range 30 to 60 mm Hg, the
2 2
change in the accuracy of the partial pressure reading shall not exceed ±6 mm Hg.

– 14 – 60601-2-23 © IEC:1999(E)
36.202.2.2 a)
Replacement:
The EQUIPMENT shall be exposed to an a.m. r.f. field with 80 % modulation at a frequency of
0,1 Hz.
The TRANSDUCER cable, if longer than 1 m, shall be shortened to 1 m as shown in figure 104.
The signal input, signal output cables (if applicable) and the POWER SUPPLY CORD shall be
arranged horizontally and vertically from the EQUIPMENT (figure 104).
36.202.3 Transients
Addition:
Immediately following each of the tests of 36.202.3.1 and 36.202.3.2, the EQUIPMENT shall
return to its previous operating mode within 30 s, without loss of any stored data.
36.202.5 Conducted disturbances induced by radio frequency fields above 9 kHz
When exposed to conducted electromagnetic fields via the POWER SUPPLY CORD, the
EQUIPMENT shall operate within normal specifications.
The test methods and instruments shall be as described in IEC 61000-4-6.
The noise voltage that is injected into the MAINS power input shall be 3 V r.m.s. over the
frequency range of 150 kHz to 80 MHz. It shall be modulated at 80 % index at any frequency
within the passband of the EQUIPMENT.
36.202.6 Magnetic fields
Additions:
No degradation of performance or loss of functionality shall occur when the EQUIPMENT is
exposed to the following magnetic field:
Magnetic field intensity: 3 A/m
Frequency: SUPPLY MAINS
Compliance is tested by exposing the EQUIPMENT to the specified field on all its faces. The
TRANSDUCER and PATIENT lead shall be connected to the EQUIPMENT. During exposure, the
EQUIPMENT shall function within the normal limits of this Particular Standard.
NOTE As the EQUIPMENT is unlikely to function without the TRANSDUCER being connected (unless a simulator is
used), the TRANSDUCER and distal part of the PATIENT lead may be arranged to extend outside the magnetic field
for this test.
*36.202.7 Electrosurgery interference
No requirement.
SECTION SIX – PROTECTION AGAINST THE HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES
The clauses and subclauses of this section of the General Standard apply.

60601-2-23 © IEC:1999(E) – 15 –
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
The clauses and subclauses of this section of the General Standard apply except as follows:
42 Excessive temperatures
This clause of the General Standard applies except as follows:
42.3 Temperature of APPLIED PARTS
Additional subclauses:
QUIPMENT APPLIED PART
42.3.101 E having a heater in the shall be provided with means for
controlling the temperature of the APPLIED PART.
42.3.102 Means shall also be provided for indicating numerically the SET TEMPERATURE
(during temperature setting and on request of the OPERATOR).
*42.3.103 The SET TEMPERATURE shall not exceed 45 °C.
Compliance is checked by inspection.
APPLIED PART INTERFACE SET
42.3.104 The temperature of the shall not exceed the
TEMPERATURE by more than 0,6 °C for more than a total of 20 s, in any period of 30 minutes
after the settling period recommended by the manufacturer (see also 42.3.107).
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 102; apply force to compress foam to half thickness; take readings from the
thermocouple.
With the TRANSDUCER mounted as in figure 102, the temperature of the APPLIED PART
INTERFACE is measured continuously in any 30 minutes in the four hours after energising the
EQUIPMENT
, taking into account the settling period.
Operation shall be as in the instructions for use, with any recommended contact medium.
EQUIPMENT having a heater in the APPLIED PART shall be provided with a
42.3.105
TEMPERATURE LIMITER for the APPLIED PART INTERFACE which cannot be adjusted by the
OPERATOR and which functions independently of the normal temperature control means,
which, in the SINGLE FAULT CONDITION of 3.6, prevents the temperature of the APPLIED PART
INTERFACE from exceeding 45 °C for more than a total of 20 s, with a maximum of 46 °C.
Compliance is checked by inspection for the presence of a TEMPERATURE LIMITER and by
introducing a SINGLE FAULT CONDITION as described in 3.6, then by measuring the temperature
APPLIED PART
of the when mounted as in figure 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.

– 16 – 60601-2-23 © IEC:1999(E)
For EQUIPMENT having an INTERNAL ELECTRICAL POWER SOURCE, the requirements in subclauses
42.3.101 to 42.3.105 shall be met for any state of discharge of the INTERNAL ELECTRICAL
POWER SOURCE.
42.3.106 The OPERATOR shall be made aware of the operation of a TEMPERATURE LIMITER by
a visual indication.
Compliance is checked by inspection.
*42.3.107 There shall be a visual indication showing when the temperature of the APPLIED
PART INTERFACE exceeds the SET TEMPERATURE by more than 0,6 °C.
Compliance is checked by inspection.
42.5 Guards
Amendment:
Not applicable to any heated stylus or printing element of the EQUIPMENT.
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning,
sterilization, disinfection and compatibility
This clause of the General Standard applies except as follows:
44.3 Spillage
Addition, after the compliance test:
If the EQUIPMENT forms part of a MULTIFUNCTION PATIENT MONITORING EQUIPMENT, it shall not be
subjected to the foregoing test, unless the EQUIPMENT or part of the EQUIPMENT is separable
whilst remaining functional, in which case the said EQUIPMENT or part of the EQUIPMENT shall
be subjected to the above test.
*44.6 Ingress of liquids
Addition:
TRANSDUCERS shall be protected against the ingress of liquids. After the following test, the
EQUIPMENT shall function as described in the ACCOMPANYING DOCUMENTS.
Compliance is checked by immersing the TRANSDUCER during normal function for 1 h, with at
least 10 cm of its lead wire immersed in water 5 cm deep and having the same temperature
as the set temperature ±0,6 °C.
49 Interruption of the power supply
This clause of the General Standard applies except as follows:

60601-2-23 © IEC:1999(E) – 17 –
49.3 Replacement:
a) When the SUPPLY MAINS to the EQUIPMENT in which there is no INTERNAL ELECTRICAL POWER
SOURCE is interrupted for less than 30 s and the TRANSDUCER is energised, either
1) the mode of operation and all OPERATOR settings shall not be changed, or
2) the TRANSDUCER shall be de-energised and any indication of partial pressure shall be
cancelled.
Compliance is checked by observing the EQUIPMENT operating mode and interrupting the
SUPPLY MAINS for a period of 10 to 30 s, any ON-OFF switch on the EQUIPMENT being left in
the "ON" position.
b) When the SUPPLY MAINS to the EQUIPMENT in which there is no INTERNAL ELECTRICAL POWER
SOURCE is interrupted for more than 3
...