IEC 60601-2-23:1999

Medical electrical equipment - Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment

Specifies requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment, whether this equipment is stand alone or part of a system. Applies to transcutaneous monitors used with adults, children and neonates, and it includes the use of these devices in foetal monitoring during birth.

General Information

• Status: Published
• Publication Date: 09-Dec-1999
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 25-Feb-2011

Relations

• Revised: IEC 60601-2-23:2011 - Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
• Effective Date: 05-Sep-2023

Standards Content (Sample)

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: [phone] e-mail: [e-mail] 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,
...