SIST EN IEC 60601-2-39:2025

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 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 matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence between
any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) IEC draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). IEC takes no position concerning the evidence, validity or applicability of any claimed patent rights in
respect thereof. As of the date of publication of this document, IEC had not received notice of (a) patent(s), which
may be required to implement this document. However, implementers are cautioned that this may not represent
the latest information, which may be obtained from the patent database available at https://patents.iec.ch. IEC
shall not be held responsible for identifying any or all such patent rights.
IEC 60601-2-39 has been prepared by subcommittee 62D: Particular medical equipment,
software, and systems, of IEC technical committee 62: Medical equipment, software, and
systems. It is an International Standard.
This fourth edition cancels and replaces the third edition published in 2018. This edition
constitutes a technical revision.

IEC 60601-2-39:2024 © IEC 2024 – 5 –
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.
The text of this International Standard is based on the following documents:
Draft Report on voting
62D/2162/FDIS 62D/2182/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this International Standard is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/publications.
In this document, the following print types are used:
– requirements and definitions: roman type;
– test specifications: italic type;
– informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type;
– terms defined in Clause 3 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020, in this document or as noted: SMALL CAPITALS.
In referring to the structure of this document, the term:
– "clause" means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– "subclause" means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
– 6 – IEC 60601-2-39:2024 © IEC 2024
References to clauses within this document are preceded by the term "Clause" followed by the
clause number. References to subclauses within this document are by number only.
In this document, the conjunctive "or" is used as an "inclusive or" so a statement is true if any
combination of the conditions is true.
The verbal forms used in this document conform to usage described in Clause 7 of the ISO/IEC
Directives, Part 2. For the purposes of this document, the auxiliary verb:
– "shall" means that compliance with a requirement or a test is mandatory for compliance with
this document;
– "should" means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
– "may" is used to describe a permissible way to achieve compliance with a requirement or
test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
• reconfirmed,
• withdrawn, or
• revised.
NOTE The attention of the users of this document is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised IEC publication in
which to make products in accordance with the new requirements and to equip themselves for conducting new or
revised tests. It is the recommendation of the committees that the content of this publication be adopted for
implementation nationally not earlier than 3 years from the date of publication.

IMPORTANT – The "colour inside" logo on the cover page of this document indicates
that it contains colours which are considered to be useful for the correct understanding
of its contents. Users should therefore print this document using a colour printer.

IEC 60601-2-39:2024 © IEC 2024 – 7 –
INTRODUCTION
The minimum safety requirements specified in this document are considered to provide for a
practical degree of safety in the operation of PERITONEAL DIALYSIS ME EQUIPMENT.

– 8 – IEC 60601-2-39:2024 © IEC 2024
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-39: Particular requirements for the basic safety and essential
performance of peritoneal dialysis equipment

201.1 Scope, object and related standards
Clause 1 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/
AMD2:2020 applies, except as follows:
201.1.1 Scope
Replacement:
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PERITONEAL
, hereafter referred to as PD EQUIPMENT. It applies to PD EQUIPMENT
DIALYSIS ME 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
ME EQUIPMENT and to ME SYSTEMS, as relevant.
case, the clause or subclause applies both to
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
are intended for use either by medical staff or for use by the PATIENT or other trained
EQUIPMENT
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 [1]) ,
– 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 [2]).
___________
Numbers in square brackets refer to the Bibliography.

IEC 60601-2-39:2024 © IEC 2024 – 9 –
201.1.2 Object
Replacement:
The object of this document is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for PD EQUIPMENT.
201.1.3 Collateral standards
Addition:
This document refers to those applicable collateral standards that are listed in Clause 2 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and
Clause 201.2 of this document.
IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-8:2006,
IEC 60601-1-8:2006/AMD1:2012 and IEC 60601-1-8:2006/AMD2:2020, IEC 60601-1-10:2007,
IEC 60601-1-10:2007/AMD1:2013 and IEC 60601-1-10:2007/AMD2:2020,
IEC 60601-1-11:2015 and IEC 60601-1-11:2015/AMD1:2020 apply as modified in Clauses 202,
208, 210 and 211.
IEC 60601-1-3 does not apply. IEC 60601-1-9:2007, IEC 60601-1-9:2007/AMD1:2013 and
IEC 60601-1-9:2007/AMD2:2020 does not apply as noted in Clause 209.
All other published collateral standards in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
requirements.
PERFORMANCE
A requirement of a particular standard takes priority over IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
The numbering of clauses and subclauses of this document corresponds to that of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 with the
prefix "201" (e.g. 201.1 in this document addresses the content of Clause 1 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020) or
applicable collateral standard with the prefix "20x" where x is the final digit(s) of the collateral
standard document number (e.g. 202.4 in this document addresses the content of Clause 4 of
the IEC 60601-1-2 collateral standard, 203.4 in this document addresses the content of Clause
4 of the IEC 60601-1-3 collateral standard, etc.). The changes to the text of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are specified by the use of
the following words:
"Replacement" means that the clause or subclause of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or applicable collateral
standard is replaced completely by the text of this document.
"Addition" means that the text of this document is additional to the requirements of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or
applicable collateral standard.

– 10 – IEC 60601-2-39:2024 © IEC 2024
"Amendment" means that the clause or subclause of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or applicable collateral
standard is amended as indicated by the text of this document.
Subclauses, figures or tables which are additional to those of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are numbered starting from
201.101. However, due to the fact that definitions in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020are numbered 3.1 through
3.154, additional definitions in this document are numbered beginning from 201.3.201.
Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where "x" is the number of the collateral standard, for example 202
for IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this document" is used to make reference to IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, any applicable collateral
standards and this document taken together.
Where there is no corresponding clause or subclause in this document, the clause or subclause
of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or
applicable collateral standard, although possibly not relevant, applies without modification;
where it is intended that any part of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 or applicable collateral standard, although possibly relevant, is
not to be applied, a statement to that effect is given in this document.
201.2 Normative references
NOTE Informative references are listed in the Bibliography.
Clause 2 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/
AMD2:2020 applies, except as follows:
Addition:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
IEC 60601-1-10:2007, Medical electrical equipment – Part 1-10: General requirements for basic
safety and essential performance – Collateral Standard: Requirements for the development of
physiologic closed-loop controllers
IEC 60601-1-10:2007/AMD1:2013
IEC 60601-1-10:2007/AMD2:2020
IEC 60601-1-11:2015, Medical electrical equipment – Part 1-11: 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
IEC 60601-1-11:2015/AMD1:2020
IEC 61672-1:2013, Electroacoustics – Sound level meters – Part 1: Specifications
ISO 3744:2010, Acoustics – Determination of sound power levels and sound energy levels of
noise sources using sound pressure – Engineering methods for an essentially free field over a
reflecting plane
IEC 60601-2-39:2024 © IEC 2024 – 11 –
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, IEC 60601-1-2:2014 and
IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012 and
IEC 60601-1-8:2006/AMD2:2020, IEC 60601-1-10:2007, IEC 60601-1-10:2007/AMD1:2013
and IEC 60601-1-10:2007/AMD2:2020, IEC 60601-1-11:2015 and
IEC 60601-1-11:2015/AMD1:2020 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following
addresses:
• IEC Electropedia: available at https://www.electropedia.org/
• ISO Online browsing platform: available at https://www.iso.org/obp
NOTE Refer to section "Index of defined terms used in this particular standard" for the index of defined terms.
201.3.8
* APPLIED PART
Replacement:
DIALYZING SOLUTION CIRCUIT and all parts permanently and conductively connected to it
Note 1 to entry: See Figure AA.1 in Informative Annex AA, Clause 201.16 and Subclause 201.16.6.3.
Note 2 to entry: One example of an APPLIED PART is the DIALYSING SOLUTION CIRCUIT including pre-manufactured
DIALYSING SOLUTION bags, extension lines, and drain bags in a stand-alone system connected during treatment.
Note 3 to entry: Another example of an APPLIED PART is the DIALYSING SOLUTION CIRCUIT including connected
DIALYSING SOLUTION bags, that are online prepared before treatment without the PATIENT connected and drain bags.
During treatment the online preparation part of the PD EQUIPMENT is conductively disconnected.
Note 4 to entry: Another example of an APPLIED PART is the DIALYSING SOLUTION CIRCUIT including all connected fluid
paths of the PD EQUIPMENT and the connection to a drain during the treatment.
201.3.78
PATIENT CONNECTION
Addition:
Note 1 to entry: The PATIENT connector(s) is/are the individual point(s) on the APPLIED PART through which a current
can flow between the PATIENT and the PD EQUIPMENT in NORMAL CONDITION or SINGLE FAULT CONDITION.
Additional terms and definitions:
201.3.201
APD ME EQUIPMENT
ME EQUIPMENT used to perform AUTOMATED PERITONEAL DIALYSIS
201.3.202
AUTOMATED PERITONEAL DIALYSIS
APD
method to perform dialysis with automated fluid exchanges in the peritoneum
201.3.203
CENTRAL DELIVERY SYSTEM
part of a ME SYSTEM which proportions DIALYSING SOLUTION CONCENTRATE and DIALYSIS WATER
for distribution as DIALYSING SOLUTION to the PD EQUIPMENT or distributes DIALYSING SOLUTION
CONCENTRATE
– 12 – IEC 60601-2-39:2024 © IEC 2024
201.3.204
DIALYSING SOLUTION
PD SOLUTION
aqueous fluid containing electrolytes and, usually, buffer and glucose, and which is intended to
exchange solutes during PERITONEAL DIALYSIS
Note 1 to entry: The DIALYSING SOLUTION could be pre-manufactured in bags as pharmaceuticals according to the
relevant pharmacopoeia monograph or be prepared by the PD EQUIPMENT or be influenced in composition by the PD
EQUIPMENT.
201.3.205
DIALYSING SOLUTION CIRCUIT
part of the fluid circuit that conveys DIALYSING SOLUTION from the PD EQUIPMENT to the peritoneal
PATIENT, from the PATIENT to the PD EQUIPMENT, and from the PD EQUIPMENT to a
cavity of the
drainage bag or drain
201.3.206
DIALYSING SOLUTION CONCENTRATE
substances which, when appropriately diluted or dissolved with DIALYSIS WATER, produce the
DIALYSING SOLUTION
201.3.207
DIALYSIS WATER
water that has been treated to meet the requirements of ISO 23500-3:2024 [3] and which is
suitable for use in PD applications, including the preparation of DIALYZING SOLUTION and
preparation of DIALYSING SOLUTION CONCENTRATE
Note 1 to entry: The words "water for dialysis", "permeate" and "reverse osmosis water" are commonly used as
synonyms of DIALYSIS WATER.
[SOURCE: ISO 23500-1:2024 [4], 3.17, modified – In the definition, addition of reference
number "[3]" and replacement of “dialysis fluid, reprocessing of dialysers, preparation of
concentrates and preparation of substitution fluid for online convective therapies” with
“DIALYZING SOLUTION and preparation of DIALYSING SOLUTION CONCENTRATE”, as well as addition
of the note.]
201.3.208
INFLOW
phase during which the peritoneal cavity is filled
Note 1 to entry: The term "fill" is commonly used as a synonym for "INFLOW".
201.3.209
ONLINE PD
PERITONEAL DIALYSIS PROCEDURE where the PD EQUIPMENT produces the DIALYSING SOLUTION for
the PERITONEAL DIALYSIS treatment
201.3.210
OUTFLOW
phase during which the peritoneal cavity is emptied
Note 1 to entry: The term "drain" is commonly used as a synonym for "OUTFLOW".
201.3.211
PERITONEAL DIALYSIS
PD
PROCESS whereby a DIALYSING SOLUTION is introduced into the peritoneal cavity of the PATIENT
and is subsequently removed
Note 1 to entry: The DIALYSING SOLUTION can be left in the peritoneal cavity for a dwell time or can be continuously
exchanged.
IEC 60601-2-39:2024 © IEC 2024 – 13 –
201.3.212
PERITONEAL DIALYSIS ME EQUIPMENT
PD EQUIPMENT
ME EQUIPMENT used to perform PERITONEAL DIALYSIS including APD ME EQUIPMENT
201.3.213
PROTECTIVE SYSTEM
automatic system, or a constructional feature, specifically designed to protect the PATIENT
against HAZARDOUS SITUATIONS
201.4 General requirements
Clause 4 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/
AMD2:2020 applies, except as follows:
201.4.3 * ESSENTIAL PERFORMANCE
Additional subclauses:
201.4.3.101 * Additional ESSENTIAL PERFORMANCE requirements
If applicable, the ESSENTIAL PERFORMANCE of PD EQUIPMENT includes, but is not limited to, the
functions found in the subclauses listed in Table 201.101, which shall be met within the
tolerances specified by the MANUFACTURER under NORMAL CONDITION.
The behaviour of the PD EQUIPMENT for ESSENTIAL PERFORMANCE in SINGLE FAULT CONDITION shall
MANUFACTURER'S RISK MANAGEMENT.
be determined by the
Table 201.101 – ESSENTIAL PERFORMANCE requirements
Requirement Subclause
DIALYSING SOLUTION flow rate during INFLOW/OUTFLOW 201.4.3.102
DIALYSING SOLUTION volume balancing (INFLOW/OUTFLOW volume) 201.4.3.103
PERITONEAL DIALYSIS dwell time 201.4.3.104
DIALYSING SOLUTION composition 201.4.3.105
DIALYSING SOLUTION temperature 201.4.3.106

NOTE 1 Some ESSENTIAL PERFORMANCES listed in Table 201.101 are dependent on the characteristics of the
disposables used. (e.g. length of the patient line, volume of the used DIALYSING SOLUTION bags).
NOTE 2 The Subclause 7.9.2.5 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/
AMD2:2020 requires giving the specifications for the ESSENTIAL PERFORMANCE in the instruction for use.
201.4.3.102 * DIALYSING SOLUTION flow rate during INFLOW/OUTFLOW
The accuracy of the DIALYSING SOLUTION flow rate administered by the PD EQUIPMENT during
INFLOW/OUTFLOW to and from the PATIENT shall be as specified by the MANUFACTURER.
NOTE 1 A DIALYSING SOLUTION flow rate during INFLOW/OUTFLOW lower than the set value is considered detrimental
for a typical treatment.
NOTE 2 For PD EQUIPMENT without an OPERATOR adjustable flow rate, it is acceptable for the values specified by
the MANUFACTURER in the instructions for use to be the minimum inflow and outflow rates.

– 14 – IEC 60601-2-39:2024 © IEC 2024
Compliance is checked under the following test conditions:
– Set up the DIALYSING SOLUTION containers as specified by the ACCOMPANYING DOCUMENTS,
otherwise at the same height as the PD EQUIPMENT.
– Set the PD EQUIPMENT to a total therapy volume of 10 l, or to an appropriate volume specified
by the MANUFACTURER.
– Set the PD EQUIPMENT to a fill volume or cycle volume of 2,0 l, or to an appropriate fill or
cycle volume specified by the MANUFACTURER.
PD EQUIPMENT to a simulated PATIENT comprising the following elements:
– Connect the
• an appropriately sized empty or partially filled fluid bag simulating the PATIENT's
peritoneal cavity, and
• a flow restrictor in line between the PD EQUIPMENT and the fluid bag, simulating the
combined flow resistance of the peritoneal catheter, transfer set and fluid connector
according to the MANUFACTURER'S recommendation. As flow restrictor for example a
60 cm silicone tube of 2,67 mm inner diameter can be used.
– Set the DIALYSING SOLUTION temperature to 37 °C, if applicable.
– Set the PD EQUIPMENT to the minimum cycle time, or to a dwell time of 0 min.
– Set the PD EQUIPMENT to operate until all DIALYSING SOLUTION processing components are
primed.
– Place the simulated PATIENT on a weighing scale located 50 cm above the PD EQUIPMENT, or
at the maximum allowable height, as specified by the MANUFACTURER.
– Set the highest DIALYSING SOLUTION INFLOW and OUTFLOW rate, if applicable.
– Measure the DIALYSING SOLUTION flow during at least 2 complete INFLOW and OUTFLOW
phases, respectively, by recording the duration of each phase, and the weight of the fluid
bag at the start and the end of each phase.
– Set the lowest DIALYSING SOLUTION INFLOW and OUTFLOW rate, if applicable.
– Measure the DIALYSING SOLUTION flow during at least 2 complete INFLOW and OUTFLOW
phases, respectively, by recording the duration of each phase, and the weight of the fluid
bag at the start and the end of each phase.
– Place the simulated PATIENT on a weighing scale located 50 cm below the PD EQUIPMENT, or
at the minimum allowable height, as specified by the MANUFACTURER.
– Set the highest DIALYSING SOLUTION INFLOW and OUTFLOW rate, if applicable.
– Measure the DIALYSING SOLUTION flow during at least 2 complete INFLOW and OUTFLOW
phases, respectively, by recording the duration of each phase, and the weight of the fluid
bag at the start and the end of each phase.
– Set the lowest DIALYSING SOLUTION INFLOW and OUTFLOW rate, if applicable.
– Measure the DIALYSING SOLUTION flow during at least 2 complete INFLOW and OUTFLOW
phases, respectively, by recording the duration of each phase, and the weight of the fluid
bag at the start and the end of each phase.
NOTE 3 It is acceptable for the simulated PATIENT to be in an ENCLOSURE controlled to approximately 37 °C to
simulate the PATIENT'S body temperature, which can be used for the PD EQUIPMENT to maintain thermal equilibrium
appropriate for pumping accuracy.
NOTE 4 It is acceptable for the minimum cycle (dwell) time to also include time needed for the PD EQUIPMENT to
reach and maintain thermal equilibrium appropriate for pumping accuracy.
The values of the DIALYSING SOLUTION flow rate shall be within the tolerances specified by the
MANUFACTURER in the instructions for use.
201.4.3.103 DIALYSING SOLUTION volume balancing (INFLOW/OUTFLOW volume)
The DIALYSING SOLUTION INFLOW and OUTFLOW volume accuracy and the volume balancing
accuracy of the PD EQUIPMENT shall be achieved as specified by the MANUFACTURER.

IEC 60601-2-39:2024 © IEC 2024 – 15 –
Compliance is checked under the following test conditions:
Test for APD ME EQUIPMENT
– Set up the DIALYSING SOLUTION containers as specified by the ACCOMPANYING DOCUMENTS,
otherwise at the same height as the PD EQUIPMENT.
– Set the PD EQUIPMENT to maximum fill volume or cycle volume.
– Connect the PD EQUIPMENT to a simulated PATIENT comprising the following elements:
• an appropriately sized empty or partially filled fluid bag simulating the PATIENT's
peritoneal cavity, and
• a flow restrictor in line between the PD EQUIPMENT and the fluid bag, simulating the
combined flow resistance of the peritoneal catheter, transfer set and fluid connector
according to the MANUFACTURER'S recommendation. As flow restrictor for example a
60 cm silicone tube
...