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prEN IEC 80601-2-23:2024

(Main)

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

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

2019-05-29 IP: Link to legislation (MDD) removed following CLC/TC 62 decision 02/2019 decision (May 2019 plenary)

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

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

General Information

Status
Not Published
Publication Date
28-Dec-2025
ICS
11.040.55 - Diagnostic equipment
Technical Committee
CLC/TC 62 - Electrical equipment in medical practice
Drafting Committee
IEC/SC 62D - IEC_SC_62D
Current Stage
4020 - Enquiry circulated - Enquiry
Start Date
07-Jun-2024
Completion Date
07-Jun-2024
Directive
2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
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
M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
Ref Project
oSIST 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

Relations

Revises
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
Effective Date
23-Jan-2023

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SLOVENSKI STANDARD
oSIST prEN IEC 80601-2-23:2024
01-julij-2024
Medicinska električna oprema - 2-23. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za skozikožno (transkutano) nadzorovanje delnega
(parcialnega) krvnega tlaka
Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and
essential performance of transcutaneous partial pressure monitoring equipment
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
Ta slovenski standard je istoveten z: prEN IEC 80601-2-23:2024
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
oSIST prEN IEC 80601-2-23:2024 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN IEC 80601-2-23:2024

---------------------- Page: 2 ----------------------
oSIST prEN IEC 80601-2-23:2024
62D/2133/CDV

COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 80601-2-23 ED1
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2024-06-07 2024-08-30
SUPERSEDES DOCUMENTS:
62D/2037A/RR

IEC SC 62D : PARTICULAR MEDICAL EQUIPMENT, SOFTWARE, AND SYSTEMS
SECRETARIAT: SECRETARY:
United States of America Ms Ladan Bulookbashi
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:


Other TC/SCs are requested to indicate their interest, if any,
in this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft for
Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.

This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which t hey
are aware and to provide supporting documentation.
Recipients of this document are invited to submit, with their comments, notification of any relevant “In Some Countries” clau ses
to be included should this proposal proceed. Recipients are reminded that the CDV stage is the final stage for submitting ISC
clauses. (SEE AC/22/2007 OR NEW GUIDANCE DOC).

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

PROPOSED STABILITY DATE: 2030

NOTE FROM TC/SC OFFICERS:

Copyright © 2024 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to download this
electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions. You
may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without permis sion
in writing from IEC.

---------------------- Page: 3 ----------------------
oSIST prEN IEC 80601-2-23:2024
62D/2133/CDV – 2 – IEC CDV 80601-2-23 © IEC:2024
1 CONTENTS
2 FOREWORD . 5
3 INTRODUCTION . 9
4 201.1 Scope, object and related standards. 10
5 201.1.1 * Scope . 10
6 201.1.2 Object . 10
7 201.1.3 Collateral standards . 11
8 201.1.4 Particular standards . 11
9 201.2 Normative references . 12
10 201.3 Terms and definitions . 12
11 201.4 General requirements . 13
12 201.4.7 SINGLE FAULT CONDITION for ME EQUIPMENT . 13
13 201.4.101 Additional ESSENTIAL PERFORMANCE requi
...

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