Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment (IEC 60601-2-39:2018)

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
PERITONEAL DIALYSIS ME EQUIPMENT as defined in 201.3.208, 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.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within
the scope of this document are not covered by specific requirements in this document except
in 7.2.13 and 8.4.1 of the general standard.
This document can also be applied to PD EQUIPMENT used for compensation or alleviation of
disease, injury or disability.
These particular requirements do not apply to the DIALYSING SOLUTION, or the DIALYSING
SOLUTION CIRCUIT.

Medizinische elektrische Geräte - Teil 2-39: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Peritoneal-Dialyse-Geräten (IEC 60601-2-39:2018)

Appareils électromédicaux - Partie 2-39: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de dialyse péritonéale (IEC 60601-2-39:2018)

NEW!IEC 60601-2-39:2018 est disponible sous forme de IEC 60601-2-39:2018 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.L'IEC 60601-2-39:2018 s'applique à la sécurité de base et aux performances essentielles des appareils électromédicaux de dialyse péritonéale. Elle s'applique aux appareils de dialyse péritonéale destinés à être utilisés soit par le personnel médical soit sous la supervision d'experts médicaux, y compris les appareils de dialyse péritonéalemis en fonctionnement par le patient, que l'appareil de dialyse péritonéale soit utilisé dans un hôpital ou dans un environnement domestique. Cette troisième édition annule et remplace la seconde édition de l'IEC 60601-2-39 dont elle constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente: - actualisation des références à l'IEC 60601-1:2005 et l'IEC 60601-1:2005/AMD1:2012, des références et des exigences à l'IEC 60601-1-2:2014, des références à l'IEC 60601-1-6:2010 et l'IEC 60601-1-6:2010/AMD1:2013, des références et des exigences à l'IEC 60601-1-8:2006 et l'IEC 60601-1-8:2006/AMD1:2012, et des références et des exigences à l'IEC 60601-1-11:2015; - améliorations d'ordre rédactionnel; - amélioration des articles/paragraphes traitant des exigences relatives aux performances essentielles; - nouvelles exigences concernant la coupure de l'alimentation.

Medicinska električna oprema - 2-39. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za trebušno dializo (IEC 60601-2-39:2018)

Ta del standard IEC 60601 se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI OPREME ZA TREBUŠNO DIALIZO (v nadaljevanju »OPREMA ZA TREBUŠNO DIALIZO«), kot je določeno v točki 201.3.208. Uporablja se za OPREMO ZA TREBUŠNO DIALIZO, ki jo uporablja zdravniško osebje ali se uporablja pod nadzorom oseb s strokovnim medicinskim znanjem, vključno z OPREMO ZA TREBUŠNO DIALIZO, ki jo upravlja PACIENT, ne glede na to, ali se OPREMA ZA TREBUŠNO DIALIZO uporablja v bolnišnici ali doma.
Če je točka ali podtočka namenjena samo obravnavi ELEKTROMEDICINSKE OPREME ali ELEKTROMEDICINSKIH SISTEMOV, bo to zapisano v naslovu in vsebini točke ali podtočke. Če ni zapisano, točka ali podtočka obravnava ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME.
Posebne zahteve tega dokumenta ne vključujejo temeljnih TVEGANJ pri nameravani fiziološki funkciji ELEKTROMEDICINSKE OPREME in SISTEMOV, ki spadajo na področje uporabe tega dokumenta, razen v poglavjih 7.2.13 in 8.4.1 splošnega standarda.
Ta dokument se lahko uporablja tudi za OPREMO ZA TREBUŠNO DIALIZO, ki se uporablja za lajšanje bolezni, poškodb ali invalidnosti.
Te posebne zahteve se ne uporabljajo za DIALIZNO RAZTOPINO ali OBTOK DIALIZNE RAZTOPINE.

General Information

Status
Published
Publication Date
05-Jun-2019
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
30-May-2019
Due Date
04-Aug-2019
Completion Date
06-Jun-2019

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SLOVENSKI STANDARD
SIST EN IEC 60601-2-39:2019
01-julij-2019
Nadomešča:
SIST EN 60601-2-39:2008
SIST EN 60601-2-39:2008/A11:2012
Medicinska električna oprema - 2-39. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za trebušno dializo (IEC 60601-2-39:2018)

Medical electrical equipment - Part 2-39: Particular requirements for basic safety and

essential performance of peritoneal dialysis equipment (IEC 60601-2-39:2018)

Medizinische elektrische Geräte - Teil 2-39: Besondere Festlegungen für die Sicherheit

einschließlich der wesentlichen Leistungsmerkmale von Peritoneal-Dialyse-Geräten (IEC

60601-2-39:2018)

Appareils électromédicaux - Partie 2-39: Exigences particulières pour la sécurité de base

et les performances essentielles des appareils de dialyse péritonéale (IEC 60601-2-

39:2018)
Ta slovenski standard je istoveten z: EN IEC 60601-2-39:2019
ICS:
11.040.99 Druga medicinska oprema Other medical equipment
SIST EN IEC 60601-2-39:2019 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 60601-2-39:2019
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SIST EN IEC 60601-2-39:2019
EUROPEAN STANDARD EN IEC 60601-2-39
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2019
ICS 11.040.99 Supersedes EN 60601-2-39:2008
English Version
Medical electrical equipment - Part 2-39: Particular requirements
for basic safety and essential performance of peritoneal dialysis
equipment
(IEC 60601-2-39:2018)

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 60601-2-39:2018) Geräten
(IEC 60601-2-39:2018)

This European Standard was approved by CENELEC on 2018-05-11. 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, Serbia, 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: Rue de la Science 23, B-1040 Brussels

© 2019 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.

Ref. No. EN IEC 60601-2-39:2019 E
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SIST EN IEC 60601-2-39:2019
EN IEC 60601-2-39:2019 (E)
European foreword

The text of document 62D/1558/FDIS, future edition 3 of IEC 60601-2-39, 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 IEC 60601-2-39:2019.
The following dates are fixed:

• latest date by which the document has to be implemented at national (dop) 2019-11-24

level by publication of an identical national standard or by endorsement

• latest date by which the national standards conflicting with the (dow) 2022-05-24

document have to be withdrawn
This document supersedes EN 60601-2-39:2008.

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.

Endorsement notice

The text of the International Standard IEC 60601-2-39:2018 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 standards

indicated:
IEC 60601-1-6:2010 NOTE Harmonized as EN 60601-1-6:2010 (not modified)
IEC 60601-1-9:2007 NOTE Harmonized as EN 60601-1-9:2008 (not modified)
IEC 60601-1-10:2007 NOTE Harmonized as EN 60601-1-10:2008 (not modified)
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SIST EN IEC 60601-2-39:2019
EN IEC 60601-2-39:2019 (E)
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.cenelec.eu.
Annex ZA of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year
Replacement
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
IEC 60601-1-6 2010 Medical electrical equipment - Part 1-6: EN 60601-1-6 2010
General requirements for basic safety and
essential performance - Collateral
standard: Usability
+ A1 2013 + A1 2015
IEC 60601-1-8 2006 Medical electrical equipment - Part 1-8: EN 60601-1-8 2007
General requirements for basic safety and
essential performance - Collateral
Standard: General requirements, tests and
guidance for alarm systems in medical
electrical equipment and medical electrical
systems
- - + corrigendum Mar. 2010
+ A1 2012 + A1 2013
- - + AC 2014
- - + A11 2017
Addition

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
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SIST EN IEC 60601-2-39:2019
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SIST EN IEC 60601-2-39:2019
IEC 60601-2-39
Edition 3.0 2018-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-39: Particular requirements for 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 978-2-8322-5552-0

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 7 ----------------------
SIST EN IEC 60601-2-39:2019
– 2 – IEC 60601-2-39:2018 © IEC 2018
CONTENTS

FOREWORD ........................................................................................................................... 3

INTRODUCTION ..................................................................................................................... 6

201.1 Scope, object and related standards ......................................................................... 7

201.2 Normative references ................................................................................................ 9

201.3 Terms and definitions ................................................................................................ 9

201.4 General requirements .............................................................................................. 10

201.5 General requirements for testing ME EQUIPMENT ....................................................... 13

201.6 Classification of ME EQUIPMENT and ME SYSTEMS ...................................................... 14

201.7 ME EQUIPMENT identification, marking and documents .............................................. 14

201.8 Protection against electrical HAZARDS from ME EQUIPMENT ........................................ 15

201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS .............. 16

201.10 Protection against unwanted and excessive radiation HAZARDS ................................ 16

201.11 Protection against excessive temperatures and other HAZARDS ................................ 16

201.12 Accuracy of controls and instruments and protection against hazardous

outputs .................................................................................................................... 17

201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT ................................. 19

201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) ............................................... 19

201.15 Construction of ME EQUIPMENT ................................................................................. 19

201.16 ME SYSTEMS ............................................................................................................ 19

201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS ............................. 20

202 Electromagnetic disturbances – Requirements and tests ......................................... 20

208 * General requirements, tests and guidance for ALARM SYSTEMS in MEDICAL

ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS ......................................... 20

209 Requirements for environmentally conscious design ............................................... 21

211 Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL

SYSTEMS used in the HOME HEALTHCARE ENVIRONMENT .............................................. 22

Annexes ............................................................................................................................... 23

Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic

mixtures ................................................................................................................................ 24

Annex AA (informative) Particular guidance and rationale .................................................... 25

Bibliography .......................................................................................................................... 26

Index of defined terms used in this particular standard .......................................................... 27

Table 201.101 – ESSENTIAL PERFORMANCE requirements ........................................................ 11

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SIST EN IEC 60601-2-39:2019
IEC 60601-2-39:2018 © IEC 2018 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-39: Particular requirements for 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) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of

patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

International standard IEC 60601-2-39 has been prepared by IEC subcommittee 62D:

Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical

practice.

This third edition cancels and replaces the second edition published in 2007. This edition

constitutes a technical revision.

This edition includes the following significant technical changes with respect to the previous

edition:

a) update of the references to IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, of

references and requirements to IEC 60601-1-2:2014, of references to IEC 60601-1-6:2010

and IEC 60601-1-6:2010/AMD1:2013, of references and requirements to IEC 60601-1-
8:2006 and IEC 60601-1-8:2006/AMD1:2012 and of references and requirements to
IEC 60601-1-11:2015;
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SIST EN IEC 60601-2-39:2019
– 4 – IEC 60601-2-39:2018 © IEC 2018
b) editorial improvements;
c) improvement of the essential performance requirements clause/subclauses;
d) new requirements for the interruption of the power supply.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/1558/FDIS 62D/1586/RVD

Full information on the voting for the approval of this particular standard can be found in the

report on voting indicated in the above table.

This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

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 THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD 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).

References to clauses within this document are preceded by the term "Clause" followed by

the clause number. References to subclauses within this particular standard 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.
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SIST EN IEC 60601-2-39:2019
IEC 60601-2-39:2018 © IEC 2018 – 5 –

The committee has decided that the contents of this publication will remain unchanged until

the stability date indicated on the IEC website under "http://webstore.iec.ch" in the data

related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

NOTE The attention of 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.
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SIST EN IEC 60601-2-39:2019
– 6 – IEC 60601-2-39:2018 © IEC 2018
INTRODUCTION

The minimum safety requirements specified in this particular standard are considered to

provide for a practical degree of safety in the operation of PERITONEAL DIALYSIS ME EQUIPMENT.

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SIST EN IEC 60601-2-39:2019
IEC 60601-2-39:2018 © IEC 2018 – 7 –
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-39: Particular requirements for basic safety and essential
performance of peritoneal dialysis equipment
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of

PERITONEAL DIALYSIS ME EQUIPMENT as defined in 201.3.208, 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.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within

the scope of this document are not covered by specific requirements in this document except

in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.

This document can also be applied to PD EQUIPMENT used for compensation or alleviation of

disease, injury or disability.

These particular requirements do not apply to the DIALYSING SOLUTION, or the DIALYSING

SOLUTION CIRCUIT.
201.1.2 Object
Replacement:

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL

PERFORMANCE requirements for PD EQUIPMENT as defined in 201.3.208.
201.1.3 Collateral standards
Addition:

This particular standard refers to those applicable collateral standards that are listed in

Clause 2 of the general standard and Clause 201.2 of this particular standard.
______________

The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –

Part 1: General requirements for basic safety and essential performance.
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SIST EN IEC 60601-2-39:2019
– 8 – IEC 60601-2-39:2018 © IEC 2018
IEC 60601-1-2:2014, IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012, and

IEC 60601-1-11:2015 apply as modified in Clauses 202, 208 and 211. IEC 60601-1-3 and

IEC 60601-1-12 do not apply. IEC 60601-1-9:2007 and IEC 60601-1-9:2007/AMD1:2013 do

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 general standard and collateral standards as appropriate for the particular

ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.

For brevity, IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 are referred to in this

particular standard as the general standard. Collateral standards are referred to by their

document number.

The numbering of clauses and subclauses of this particular standard corresponds to that of

the general standard with the prefix "201" (e.g. 201.1 in this document addresses the content

of Clause 1 of the general standard) 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

particular standard addresses the content of Clause 4 of the 60601-1-2 collateral standard,

203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3 collateral

standard, etc.). The changes to the text of the general standard are specified by the use of

the following words:

"Replacement" means that the clause or subclause of the general standard or applicable

collateral standard is replaced completely by the text of this particular standard.

"Addition" means that the text of this particular standard is additional to the requirements of

the general standard or applicable collateral standard.

"Amendment" means that the clause or subclause of the general standard or applicable

collateral standard is amended as indicated by the text of this particular standard.

Subclauses, figures or tables which are additional to those of the general standard are

numbered starting from 201.101. However, due to the fact that definitions in the general

standard are numbered 3.1 through 3.147, 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 the general standard, any applicable

collateral standards and this particular standard taken together.

Where there is no corresponding clause or subclause in this particular standard, the clause or

subclause of the general standard or applicable collateral standard, although possibly not

relevant, applies without modification; where it is intended that any part of the general

standard or applicable collateral standard, although possibly relevant, is not to be applied, a

statement to that effect is given in this particular standard.
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SIST EN IEC 60601-2-39:2019
IEC 60601-2-39:2018 © IEC 2018 – 9 –
201.2 Normative references
NOTE Informative references are listed in the bibliography.
Clause 2 of the general standard applies, except as follows:
Replacement:

IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic

safety and essential performance – Collateral Standard: Electromagnetic disturbances –

Requirements and tests

IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic

safety and essential performance – Collateral standard: Usability
IEC 60601-1-6:2010/AMD1:2013

IEC 60601-1-8:2006, Medical electrical equipment – Part 1-8: General requirements for basic

safety and essential performance – Collateral Standard: General requirements, tests and

guidance for alarm systems in medical electrical equipment and medical electrical systems

IEC 60601-1-8:2006/AMD1:2012
Addition:

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

201.3 Terms and definitions

For the purposes of this document, the terms and definitions specified in IEC 60601-1:2005

and IEC 60601-1:2005/AMD1:2012, IEC 60601-1-2:2014, IEC 60601-1-8:2006 and
IEC 60601-1-8:2006/AMD1:2012, IEC 60601-1-11:2015 and the following apply.

ISO and IEC maintain terminological databases for use in standardization at the following

addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
NOTE An index of defined terms is found beginning on page 27.
Addition:
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
DIALYSING SOLUTION
PD SOLUTION

aqueous fluid containing electrolytes and, usually, buffer and glucose, and which is intended

to exchange solutes during PERITONEAL DIALYSIS
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SIST EN IEC 60601-2-39:2019
– 10 – IEC 60601-2-39:2018 © IEC 2018

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.
201.3.204
DIALYSING SOLUTION CIRCUIT
DIALYSING SOLUTION from the PD EQUIPMENT to the
part of the fluid circuit that conveys

peritoneal cavity of the PATIENT, and subsequently to a drainage bag or drain, or parts

permanently and conductively connected to the fluid circuit
Note 1 to entry: This is an APPLIED PART.
201.3.205
INFLOW
phase during which the peritoneal cavity is filled
Note 1 to entry: The term "fill" is commonly used as a synonym for "INFLOW".
201.3.206
OUTFLOW
phase during which the peritoneal cavity is emptied
Note 1 to entry: The term "drain" is commonly used as a synonym for "OUTFLOW".
201.3.207
PERITONEAL DIALYSIS

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 may be left in the peritoneal cavity for a dwell time or may be

continuously exchanged.
201.3.208
PERITONEAL DIALYSIS ME EQUIPMENT
PD EQUIPMENT
ME EQUIPMENT used to perform PERITONEAL DIALYSIS including APD ME EQUIPMENT
201.3.209
PROTECTIVE SYSTEM

automatic system, or a constructional feature, specifically designed to protect the PATIENT

against HAZARDOUS SITUATIONS
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 ESSENTIAL PERFORMA
...

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