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

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-23:2015
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
SIST EN 60601-2-23:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-23:2015

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SIST EN 60601-2-23:2015


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

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SIST EN 60601-2-23:2015
EN 60601-2-23:2015
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.
2

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SIST EN 60601-2-23:2015
EN 60601-2-23:2015
Annex ZA
(normative)

Normative references to international pub
...