EN 60601-2-23:2015

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 applies to the basic safety and essential performance of transcutaneous partial pressure monitoring equipment. It applies to transcutaneous monitors used with adults, children and neonates, and it includes the use of these devices in foetal monitoring during birth. IEC 60601-2-23:2011 does not apply to haemoglobin saturation oximeters or to devices applied to surfaces of the body other than the skin (for example conjunctiva, mucosa). 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.

Medizinische elektrische Geräte - Teil 2-23: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Geräten für die transkutane Partialdrucküberwachung

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

La CEI 60601-2-23:2011 s'applique à la sécurité de base et aux performances essentielles des appareils de surveillance de la pression partielle transcutanée. Elle s'applique aux moniteurs transcutanés utilisés sur des adultes, des enfants et des nouveau-nés, et elle inclut l'utilisation de ces dispositifs dans la surveillance f tale pendant l'accouchement. La CEI 60601-2-23:2011 ne s'applique pas aux oxymètres à hémoglobine saturée ou aux dispositifs appliqués sur des surfaces du corps autres que la peau (par exemple conjonctive, muqueuse). Cette troisième édition annule et remplace la deuxième édition publiée en 1999 et constitue une révision technique. La présente édition de la CEI 60601-2-23 a été mise à jour de façon à correspondre structurellement à l'édition 2005 de la CEI 60601-1.

Medicinska električna oprema - 2-23. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za skozikožno nadzorovanje delnega (parcialnega) krvnega tlaka

IEC 60601-2-23:2011 se uporablja za osnovno varnost in bistvene lastnosti opreme za skozikožno nadzorovanje delnega (parcialnega) krvnega tlaka. Uporablja se za monitorje za skozikožno nadzorovanje pri zdravljenju odraslih, otrok in novorojenčkov ter vključuje uporabo teh naprav pri nadzoru ploda med porodom. IEC 60601-2-23:2011 se ne uporablja za oksimetre, s katerimi se meri nasičenost kisika v krvi, ali naprave za uporabo na telesnih površinah, ki jih ne pokriva koža (npr. veznica, sluznica). Ta tretja izdaja razveljavlja in nadomešča drugo izdajo, objavljeno leta 1999, in predstavlja tehnično popravljeno izdajo. Ta izdaja standarda IEC 60601-2-23 je bila revidirana in strukturno usklajena z izdajo standarda IEC 60601-1:2005.

General Information

• Status: Published
• Publication Date: 22-Oct-2015
• Withdrawal Date: 14-Sep-2018
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Parallel Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 23-Oct-2015
• Completion Date: 23-Oct-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 60601-2-23:2015 - Medical electrical equipment - Part 2-23: Particular requirements for basic safety and essential performance of transcutaneous partial pressure monitoring equipment

Relations

• Replaces: EN 60601-2-23:2000 - Medical electrical equipment - Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment
• Effective Date: 28-Jan-2023
• Revised: prEN IEC 80601-2-23:2024 - Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
• Effective Date: 23-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2015
1DGRPHãþD
SIST EN 60601-2-23:2002
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLRSUHPH]DVNR]LNRåQRQDG]RURYDQMHGHOQHJDSDUFLDOQHJD
NUYQHJDWODND
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 matt
...