SIST EN IEC 60601-2-39:2025
(Main)Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
IEC 60601-2-39:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PERITONEAL DIALYSIS ME EQUIPMENT, hereafter referred to as PD EQUIPMENT. It applies to PD EQUIPMENT intended for use either by medical staff or under the supervision of medical experts, including PD EQUIPMENT operated by the PATIENT, regardless of whether the PD EQUIPMENT is used in a hospital or domestic environment.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
This document does not take into consideration specific safety details of the DIALYSING SOLUTION control system of PD EQUIPMENT using regeneration of DIALYSING SOLUTION or CENTRAL DELIVERY SYSTEMS for DIALYSING SOLUTION. It does, however, take into consideration the specific safety requirements of such PD EQUIPMENT concerning electrical safety and PATIENT safety.
This document specifies the minimum safety requirements for PD EQUIPMENT. These PD EQUIPMENT are intended for use either by medical staff or for use by the PATIENT or other trained personnel under medical supervision.
This document includes all ME EQUIPMENT that is intended to deliver a PERITONEAL DIALYSIS treatment to a PATIENT, independent of the treatment duration and location.
These particular requirements do not apply to:
– PRE-MANUFACTURED DIALYSING SOLUTION bags,
– DIALYSING SOLUTION CIRCUITS,
– DIALYSING SOLUTION CONCENTRATE,
– DIALYSIS WATER supply systems (see ISO 23500-2) ,
– CENTRAL DELIVERY SYSTEMS for DIALYSING SOLUTION CONCENTRATES, described as systems for bulk mixing concentrate at a dialysis facility,
– equipment used to perform HAEMODIALYSIS (see IEC 60601-2-16).
IEC 60601-2-39:2024 cancels and replaces the third edition published in 2018. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) update of references to IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601 1:2005/AMD2:2020, of references to IEC 60601 1 2:2014 and IEC 60601 1 2:2014/AMD1:2020, of references to IEC 60601-1-8:2006, IEC 60601 1 8:2006/AMD1:2012 and IEC 60601 1 8:2006/AMD2:2020, of references to IEC 60601 1 9:2007, IEC 60601 1 9:2007/AMD1:2013 and IEC 60601 1 9:2007/AMD2:2020, of references to IEC 60601 1 10:2007, IEC 60601 1 10:2007/AMD1:2013 and IEC 60601 1 10:2007/AMD2:2020 and of references to IEC 60601 1 11:2015 and IEC 60601 1 11:2015/AMD1:2020;
b) consideration of ESSENTIAL PERFORMANCE in SINGLE FAULT CONDITION regarding IEC 60601 1:2005/AMD1:2012/ISH1:2021;
c) including the information given in the document 62D/1771A/INF regarding 201.11.8;
d) including the information given in the document 62D/1734/INF regarding technical issues of the previous edition;
e) including SECURITY (CYBERSECURITY) requirements;
f) additions related to online PD SOLUTION generation (ONLINE PD);
g) improvements regarding the definition of the APPLIED PART;
h) improvement of the essential performance requirements clause/subclauses;
i) improvements for labelling;
j) other minor technical improvements;
k) editorial improvements.
Medizinische elektrische Geräte - Teil 2-39: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Peritoneal-Dialyse-Geräten
Appareils électromédicaux - Partie 2-39: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de dialyse péritonéale
L'IEC 60601-2-39:2024 s’applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS EM DE DIALYSE PERITONEALE, désignés ci-après sous le terme d’APPAREILS DP. Elle s’applique aux APPAREILS DP destinés à être utilisés soit par le personnel médical soit sous la surveillance d’experts médicaux, y compris les APPAREILS DP mis en fonctionnement par le PATIENT, que les APPAREILS DP soient utilisés dans un hôpital ou dans un environnement domestique.
Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux APPAREILS EM ou uniquement aux SYSTEMES EM, le titre et le contenu de cet article ou de ce paragraphe l’indiquent. Si cela n’est pas le cas, l’article ou le paragraphe s’applique à la fois aux APPAREILS EM et aux SYSTEMES EM, selon le cas.
Le présent document ne prend pas en considération les informations spécifiques de sécurité du système de contrôle de la SOLUTION DE DIALYSE des APPAREILS DP qui utilise la régénération de la SOLUTION DE DIALYSE ou des SYSTEMES DE TRANSMISSION CENTRALISES pour la SOLUTION DE DIALYSE. Il prend cependant en considération les exigences spécifiques de sécurité de ces APPAREILS DP relatives à la sécurité électrique et la sécurité du PATIENT.
Le présent document spécifie les exigences minimales de sécurité des APPAREILS DP. Les APPAREILS DP sont destinés à être utilisés par le personnel médical ou le PATIENT ou tout personnel formé et sous surveillance médicale.
Le présent document s’applique à tous les APPAREILS EM destinés à fournir un traitement par DIALYSE PERITONEALE au PATIENT, indépendamment de la durée et du lieu de traitement.
Ces exigences particulières ne s’appliquent pas:
– aux SACS POUR SOLUTION DE DIALYSE préproduite,
– aux CIRCUITS DE LA SOLUTION DE DIALYSE,
– au CONCENTRE DE SOLUTION DE DIALYSE,
– aux systèmes d’alimentation en EAU DE DIALYSE (voir l’ISO 23500-2 [1]) ,
– aux SYSTEMES DE TRANSMISSION CENTRALISES pour CONCENTRES DE SOLUTION DE DIALYSE, décrits comme des systèmes de mélange en vrac de concentrés dans un centre de dialyse,
– aux appareils utilisés pour l’HEMODIALYSE (voir l’IEC 60601-2-16 [2]).
L'IEC 60601-2-39:2024 annule et remplace la troisième édition parue en 2018. Cette édition constitue une révision technique.
Cette édition inclut les modifications techniques majeures suivantes par rapport à l’édition précédente:
a) mise à jour des références à l’IEC 60601-1:2005, l’IEC 60601-1:2005/AMD1:2012 et l’IEC 60601 1:2005/AMD2:2020, des références à l’IEC 60601 1 2:2014 et l’IEC 60601 1 2:2014/AMD1:2020, des références à l’IEC 60601-1-8:2006, l’IEC 60601 1 8:2006/AMD1:2012 et l’IEC 60601 1 8:2006/AMD2:2020,des références à l’IEC 60601 1 9:2007, l’IEC 60601 1 9:2007/AMD1:2013 et l’IEC 60601 1 9:2007/AMD2:2020, des références à l’IEC 60601 1 10:2007, l’IEC 60601 1 10:2007/AMD1:2013 et l’IEC 60601 1 10:2007/AMD2:2020 et des références à l’IEC 60601 1 11:2015 et l’IEC 60601 1 11:2015/AMD1:2020;
b) prise en considération des PERFORMANCES ESSENTIELLES en CONDITION DE PREMIER DEFAUT concernant l’IEC 60601 1:2005/AMD1:2012/ISH1:2021;
c) inclusion des informations données dans le document 62D/1771A/INF concernant le 201.11.8;
d) inclusion des informations données dans le document 62D/1734/INF concernant les questions techniques de l’édition précédente;
e) inclusion des exigences de SECURITE (CYBERSECURITE);
f) ajouts liés à la préparation en ligne de la SOLUTION DP (DP EN LIGNE);
g) améliorations apportées à la définition de la PARTIE APPLIQUEE;
Medicinska električna oprema - 2-39. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za trebušno dializo
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2025
Medicinska električna oprema - 2-39. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za trebušno dializo
Medical electrical equipment - Part 2-39: Particular requirements for basic safety and
essential performance of peritoneal dialysis equipment
Medizinische elektrische Geräte - Teil 2-39: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Peritoneal-Dialyse-Geräten
Appareils électromédicaux - Partie 2-39: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de dialyse péritonéale
Ta slovenski standard je istoveten z: EN IEC 60601-2-39:2025
ICS:
11.040.99 Druga medicinska oprema Other medical equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN IEC 60601-2-39
NORME EUROPÉENNE
EUROPÄISCHE NORM January 2025
ICS 11.040.99 Supersedes EN IEC 60601-2-39:2019
English Version
Medical electrical equipment - Part 2-39: Particular requirements
for the basic safety and essential performance of peritoneal
dialysis equipment
(IEC 60601-2-39:2024)
Appareils électromédicaux - Partie 2-39: Exigences Medizinische elektrische Geräte - Teil 2-39: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils de dialyse péritonéale wesentlichen Leistungsmerkmale von Peritoneal-Dialyse-
(IEC 60601-2-39:2024) Geräten
(IEC 60601-2-39:2024)
This European Standard was approved by CENELEC on 2025-01-15. 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60601-2-39:2025 E
European foreword
The text of document 62D/2162/FDIS, future edition 4 of IEC 60601-2-39, prepared by SC 62D
"Particular medical equipment, software, and systems" of IEC/TC 62 "Medical equipment, software,
and systems" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2026-01-31
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2028-01-31
document have to be withdrawn
This document supersedes EN IEC 60601-2-39:2019 and all of its amendments and corrigenda (if
any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 60601-2-39:2024 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standard indicated:
IEC 60601-2-16 NOTE Approved as EN IEC 60601-2-16
ISO 23500-3:2024 NOTE Approved as EN ISO 23500-3:2024 (not modified)
ISO 23500-1:2024 NOTE Approved as EN ISO 23500-1:2024 (not modified)
ISO 23500-5:2024 NOTE Approved as EN ISO 23500-5:2024 (not modified)
ISO 80369-1:2018 NOTE Approved as EN ISO 80369-1:2018 (not modified)
ISO 23500-4:2024 NOTE Approved as EN ISO 23500-4:2024 (not modified)
ISO 11197:2019 NOTE Approved as EN ISO 11197:2019 (not modified)
ISO 17664-1:2021 NOTE Approved as EN ISO 17664-1:2021 (not modified)
ISO 17664-2:2021 NOTE Approved as EN ISO 17664-2:2023 (not modified)
ISO 15883 series NOTE Approved as EN ISO 15883 series
IEC 80001-1:2021 NOTE Approved as EN IEC 80001-1:2021 (not modified)
IEC 60601-1-9:2007 NOTE Approved as EN 60601-1-9:2008 (not modified)
IEC 60601-1-9:2007/A1:2013 NOTE Approved as EN 60601-1-9:2008/A1:2013 (not modified)
IEC 60601-1-9:2007/A2:2020 NOTE Approved as EN 60601-1-9:2008/A2:2020 (not modified)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1 Where 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.cencenelec.eu.
Annex ZA of EN 60601-1:2006 , applies, except as follows:
Add:
Publication Year Title EN/HD Year
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- - + AC 2010
+ A1 2012 + A1 2013
- - + AC 2014
- - + A12 2014
+ A2 2020 + A2 2021
- - + AC 2022
- - + A13 2024
IEC 60601-1-10 2007 Medical electrical equipment - Part 1-10: EN 60601-1-10 2008
General requirements for basic safety and
essential performance - Collateral
Standard: Requirements for the
development of physiologic closed-loop
controllers
+ A1 2013 + A1 2015
+ A2 2020 + A2 2021
As impacted by EN 60601-1:2006/AC:2010, EN 60601-1:2006/A1:2013, EN 60601-1:2006/A1:2013/AC:2014,
EN 60601-1:2006/A12:2014, EN 60601-1:2006/A2:2021, EN 60601-1:2006/AC:2022-12 and
EN 60601-1:2006/A13:2024.
Publication Year Title EN/HD Year
IEC 60601-1-11 2015 Medical electrical equipment - Part 1-11: EN 60601-1-11 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Requirements for medical
electrical equipment and medical electrical
systems used in the home healthcare
environment
+ A1 2020 + A1 2021
IEC 61672-1 2013 Electroacoustics - Sound level meters - EN 61672-1 2013
Part 1: Specifications
ISO 3744 2010 Acoustics - Determination of sound power EN ISO 3744 2010
levels and sound energy levels of noise
sources using sound pressure -
Engineering methods for an essentially free
field over a reflecting plane
IEC 60601-2-39 ®
Edition 4.0 2024-12
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-39: Particular requirements for the basic safety and essential
performance of peritoneal dialysis equipment
Appareils électromédicaux –
Partie 2-39: Exigences particulières pour la sécurité de base et les
performances essentielles des appareils de dialyse péritonéale
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.99 ISBN 978-2-8327-0010-5
– 2 – IEC 60601-2-39:2024 © IEC 2024
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions . 11
201.4 General requirements . 13
201.5 General requirements for testing ME EQUIPMENT . 17
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 17
201.7 ME EQUIPMENT identification, marking and documents . 17
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 22
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 22
201.10 Protection against unwanted and excessive radiation HAZARDS . 22
201.11 Protection against excessive temperatures and other HAZARDS . 22
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 25
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 28
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 28
201.15 Construction of ME EQUIPMENT . 30
201.16 * ME SYSTEMS . 31
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 32
202 Electromagnetic disturbances – Requirements and tests . 32
208 * General requirements, tests and guidance for ALARM SYSTEMS in MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS . 33
209 Requirements for environmentally conscious design . 35
210 Requirements for the development of PHYSIOLOGIC CLOSED-LOOP
CONTROLLERS . 35
211 * Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL
SYSTEMS used in the HOME HEALTHCARE ENVIRONMENT . 35
Annexes . 36
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures . 37
Annex AA (informative) Particular guidance and rationale . 38
Bibliography . 52
Index of defined terms used in this document . 54
Figure AA.1 – Powered by SUPPLY MAINS only . 44
Figure AA.2 – Alarm at depletion of battery for limited functionality . 45
Figure AA.3 – Alarm before battery for limited functionality gets depleted (10 min
minimum) . 45
Figure AA.4 – Alarm before battery for limited functionality gets depleted (battery
lasting for equal or less than 10 min) . 46
IEC 60601-2-39:2024 © IEC 2024 – 3 –
Figure AA.5 – Alarm at battery depletion . 46
Figure AA.6 – Alarm before battery gets depleted (10 min minimum) . 47
Figure AA.7 – Example of a PD ME SYSTEM . 49
Table 201.101 – ESSENTIAL PERFORMANCE requirements . 13
– 4 – IEC 60601-2-39:2024 © IEC 2024
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-39: Particular requirements for the basic safety and essential
performance of peritoneal dialysis equipment
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide orga
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