IEC 60601-2-39:1999

Medical electrical equipment - Part 2-39: Particular requirements for the safety of peritoneal dialysis equipment

Specifies the minimum safety requirements for peritoneal dialysis equipment. Applies to equipment intended for use either by medical staff or under supervision of medical experts, including equipment operated by the patient, regardless of whether the equipment is used in a hospital or domestic environment.

Appareils électromédicaux - Partie 2-39: Règles particulières de sécurité pour les appareils de dialyse péritonéale

Spécifie les prescriptions de sécurité minimales pour les appareils de dialyse péritonéale. S'applique aux appareils destinés à être utilisés soit par le personnel médical soit sous la supervision d'experts médicaux, y compris les appareils mis en fonctionnement par le patient, que l'appareil soit utilisé dans un hôpital ou dans un environnement domestique.

General Information

• Status: Published
• Publication Date: 29-Jun-1999
• ICS: 11.040.99 - Other medical equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 27-Nov-2007

Relations

• Revised: IEC 60601-2-39:2007 - Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
• Effective Date: 05-Sep-2023

Standards Content (Sample)

INTERNATIONAL IEC
STANDARD
60601-2-39
First edition
1999-06
Medical electrical equipment –
Part 2-39:
Particular requirements for the safety
of peritoneal dialysis equipment
Appareils électromédicaux –
Partie 2-39:
Règles particulières de sécurité
pour les équipements de dialyse péritonéale

Reference number
Numbering
As from 1 January 1997 all IEC publications are issued with a designation in the
60000 series.
Consolidated publications
Consolidated versions of some IEC publications including amendments are

available. For example, edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the
base publication, the base publication incorporating amendment 1 and the base

publication incorporating amendments 1 and 2.

Validity of this publication
The technical content of IEC publications is kept under constant review by the IEC,
thus ensuring that the content reflects current technology.
Information relating to the date of the reconfirmation of the publication is available
in the IEC catalogue.
Information on the subjects under consideration and work in progress undertaken
by the technical committee which has prepared this publication, as well as the list
of publications issued, is to be found at the following IEC sources:
• IEC web site*
•
Catalogue of IEC publications
Published yearly with regular updates
(On-line catalogue)*
• IEC Bulletin
Available both at the IEC web site* and as a printed periodical
Terminology, graphical and letter symbols
For general terminology, readers are referred to IEC 60050: International
Electrotechnical Vocabulary (IEV).
For graphical symbols, and letter symbols and signs approved by the IEC for
general use, readers are referred to publications IEC 60027: Letter symbols to be
used in electrical technology, IEC 60417: Graphical symbols for use on equipment.
Index, survey and compilation of the single sheets and IEC 60617: Graphical symbols
for diagrams.
* See web site address on title page.

INTERNATIONAL IEC
STANDARD
60601-2-39
First edition
1999-06
Medical electrical equipment –
Part 2-39:
Particular requirements for the safety
of peritoneal dialysis equipment
Appareils électromédicaux –
Partie 2-39:
Règles particulières de sécurité
pour les équipements de dialyse péritonéale

 IEC 1999  Copyright - all rights reserved
No part of this publication may be reproduced or utilized in any form or by any means, electronic or
mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: [phone] e-mail: [e-mail] IEC web site http://www.iec.ch
Commission Electrotechnique Internationale
PRICE CODE
M
International Electrotechnical Commission
For price, see current catalogue

– 2 – 60601-2-39 © IEC:1999(E)

CONTENTS
Page
FOREWORD . 3

Clause
SECTION ONE – GENERAL
1 Scope and object . 5

2 Terminology and definitions . 6

3 General requirements . 7
4 General requirements for tests. 7
6 Identification, marking and documentation. 7
SECTION TWO – ENVIRONMENTAL CONDITIONS
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
19 Continuous leakage current and patient auxiliary currents . 8
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization,
disinfection and compatibility . 9
SECTION EIGHT – ACCURACY OF OPERATING DATA AND PROTECTION AGAINST
HAZARDOUS OUTPUT
51 Protection against hazardous output . 10

SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
SECTION TEN – CONSTRUCTION REQUIREMENTS
59 Construction and layout . 11
Annexes . 13

60601-2-39 © IEC:1999(E) – 3 –

INTERNATIONAL ELECTROTECHNICAL COMMISSION

______________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-39: Particular requirements for the safety

of peritoneal dialysis equipment

FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of the 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, the IEC publishes International Standards. 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. The 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 the 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 National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical specifications, technical reports or guides and they are accepted by the National
Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this technical report may be the subject of
patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
International Standard 60601-2-39 has been prepared by subcommittee 62D: Electromedical
equipment, of IEC technical committee 62: Electrical equipment in medical practice.
The text of this standard is based on the following documents:
FDIS Report on voting
62D/311/FDIS 62D/326/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has not been drafted in complete accordance with the ISO/IEC Directives,
Part 3.
Annex AA is for information only.
In this Particular Standard the following print types are used:
– requirements, compliance with which can be tested, and definitions: in roman type;
– notes, explanations, advice, introductions, general statements, exceptions and references: in smaller type;
– test specifications: in italic type;
– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR THIS PARTICULAR STANDARD: SMALL
CAPITALS.
– 4 – 60601-2-39 © IEC:1999(E)

The committee has decided that this publication remains valid until 2007. At this date, in

accordance with the committee's decision, the publication will be

• reconfirmed;
• withdrawn;
• replaced by a revised edition; or

• amended.
A bilingual version of this standard may be issued at a later date.

60601-2-39 © IEC:1999(E) – 5 –

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-39: Particular requirements for the safety

of peritoneal dialysis equipment

SECTION ONE – GENERAL
The clauses and subclauses of this section of the General Standard apply except as follows:
1 Scope and object
This clause of the General Standard applies except as follows:
1.1 Scope
Addition:
This Particular Standard specifies the minimum safety requirements for PERITONEAL DIALYSIS
EQUIPMENT as defined in 2.1.102, hereinafter referred to as EQUIPMENT. It applies to EQUIPMENT
intended for use either by medical staff or under the supervision of medical experts, including
EQUIPMENT operated by the PATIENT, regardless of whether the equipment is used in a hospital
or domestic environment.
These particular requirements do not apply to the DIALYSING SOLUTION, the DIALYSING SOLUTION
circuit, or to EQUIPMENT solely intended for use as continuous ambulatory PERITONEAL DIALYSIS
EQUIPMENT.
1.2 Object
Replacement:
The object of this Particular Standard is to establish particular requirements for the safety of
EQUIPMENT
as defined in 2.1.102.
1.3 Particular Standards
Addition:
This Particular Standard amends and supplements a set of IEC publications consisting of
IEC 60601-1:1988, Medical electrical equipment – Part 1: General requirements for safety,
amendment 1 (1991), amendment 2 (1995); IEC 60601-1-1, amendment 1 (1995), IEC 60601-1-2
(1993) and IEC 60601-1-4 (1996).
For brevity, IEC 60601-1 is referred to in this Particular Standard either as the “General
Standard” or as the “General Requirement(s)”, and IEC 60601-1-1, 60601-1-2, and 60601-1-4
as the "Collateral Standards".
The term “this standard” covers the Particular Standard used together with the General
Standard and any Collateral Standards.
The numbering of sections, clauses and subclauses of this standard corresponds to that of the
General Standard. The changes to the text of the General Standard are specified by the use of
the following words:
– 6 – 60601-2-39 © IEC:1999(E)

“Replacement” means that the clause or subclause of the General Standard is replaced

completely by the text of this standard.

“Addition” means that the text of this standard is additional to the requirements of the General

Standard.
“Amendment” means that the clause or subclause of the General Standard is amended as

indicated by the text of this standard.

Subclauses or figures which are additional to those of the General Standard are numbered

starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb),

etc.
Where there is no corresponding section, clause or subclause in this standard, the section,
clause or subclause of the General Standard, applies without modification.
Where it is intended that any part of the General Standard, although possibly relevant, is not to
be applied, a statement to that effect is given in this standard.
A requirement of this standard replacing or modifying requirements of the General Standards
takes precedence over the original requirements concerned.
2 Terminology and definitions
This clause of the General Standard applies except as follows:
2.1.5
APPLIED PART
Replacement:
The part of the DIALYSING SOLUTION circuit, that conveys DIALYSING SOLUTION from the
EQUIPMENT to the peritoneal cavity of the PATIENT, and subsequently to a drainage bag or drain,
or parts permanently and conductively connected to it, shall be considered as the APPLIED
PART.
Additional definitions:
2.1.101
PERITONEAL DIALYSIS
process whereby a DIALYSING SOLUTION is introduced into the peritoneal cavity of the PATIENT

and is subsequently removed
2.1.102
PERITONEAL DIALYSIS EQUIPMENT
EQUIPMENT used to perform PERITONEAL DIALYSIS
2.1.103
DIALYSING SOLUTION
pharmaceutical preparation (solution), according to the relevant pharmacopoeia monograph for
use with EQUIPMENT
2.1.104
INFLOW
phase during which the peritoneal cavity is filled
NOTE – The term “fill” is commonly used as a synonym for “inflow”.

60601-2-39 © IEC:1999(E) – 7 –

2.1.105
OUTFLOW
phase during which the peritoneal cavity is emptied

NOTE – The term “drain” is commonly used as a synonym for “outflow”.

2.1.106
PROTECTIVE SYSTEM
automatic system which senses a specified parameter (or parameters) or a constructional

feature, specially designed to protect the PATIENT against the SAFETY HAZARDS which may arise

3 General requirements
This clause of the General Standard applies except as follows:
3.6 Additional item:
aa) Failure of any PROTECTIVE SYSTEM.
4 General requirements for tests
This clause of the General Standard applies except as follows:
4.6 Other conditions
Addition:
When the outcome of a test may be affected by the initial temperature of the DIALYSING
SOLUTION, the temperature of the DIALYSING SOLUTION at the start of the test shall be less than
4 °C or the minimum temperature specified by the manufacturer.
6 Identification, marking and documentation
This clause of the General Standard applies except as follows:
6.8.1 General
Addition:
The ACCOMPANYING DOCUMENTS shall additionally include

– a statement pointing out the importance of an air gap between the DIALYSING SOLUTION
circuit and the drain in order to prevent back syphonage if the OUTFLOW path is open.
6.8.2 Instructions for use
Addition:
aa) The instructions for use shall additionally include the following:
1) a description of the method(s) by which any necessary disinfection or sterilization is
achieved;
2) a statement that the test procedure by which the effectiveness of any sterilization or
disinfection has been verified is available on request;
3) a statement which draws the OPERATOR's attention to the SAFETY HAZARDS associated
with the connection and disconnection of the PATIENT;

----------------------
...

NORME CEI
INTERNATIONALE
IEC
60601-2-39
INTERNATIONAL
Première édition
STANDARD
First edition
1999-06
Appareils électromédicaux –
Partie 2-39:
Règles particulières de sécurité
pour les appareils de dialyse péritonéale

Medical electrical equipment –
Part 2-39:
Particular requirements for the safety
of peritoneal dialysis equipment

Numéro de référence
Reference number
CEI/IEC 60601-2-39:2003
Numérotation des publications Publication numbering

Depuis le 1er janvier 1997, les publications de la CEI As from 1 January 1997 all IEC publications are

sont numérotées à partir de 60000. Ainsi, la CEI 34-1 issued with a designation in the 60000 series. For

devient la CEI 60034-1. example, IEC 34-1 is now referred to as IEC 60034-1.

Editions consolidées Consolidated editions

Les versions consolidées de certaines publications de la The IEC is now publishing consolidated versions of its

CEI incorporant les amendements sont disponibles. Par publications. For example, edition numbers 1.0, 1.1

exemple, les numéros d’édition 1.0, 1.1 et 1.2 indiquent and 1.2 refer, respectively, to the base publication,
respectivement la publication de base, la publication de the base publication incorporating amendment 1 and
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NORME CEI
INTERNATIONALE
IEC
60601-2-39
INTERNATIONAL
Première édition
STANDARD
First edition
1999-06
Appareils électromédicaux –
Partie 2-39:
Règles particulières de sécurité
pour les appareils de dialyse péritonéale

Medical electrical equipment –
Part 2-39:
Particular requirements for the safety
of peritoneal dialysis equipment

 IEC 2003 Droits de reproduction réservés  Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in any
utilisée sous quelque forme que ce soit et par aucun procédé, form or by any means, electronic or mechanical, including
électronique ou mécanique, y compris la photocopie et les photocopying and microfilm, without permission in writing from
microfilms, sans l'accord écrit de l'éditeur. the publisher.
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: [phone] Telefax: [phone] E-mail: [e-mail] Web: www.iec.ch
CODE PRIX
M
PRICE CODE
Commission Electrotechnique Internationale
International Electrotechnical Commission
МеждународнаяЭлектротехническаяКомиссия
Pour prix, voir catalogue en vigueur
For price, see current catalogue

– 2 – 60601-2-39 © CEI:2003
SOMMAIRE
AVANT PROPOS .4

SECTION UN – GENERALITES
1 Domaine d'application et objet.8

2 Terminologie et définitions.10

3 Prescriptions générales.12

4 Prescriptions générales relatives aux essais.12

6 Identification, marquage et documentation.12

SECTION DEUX – CONDITIONS D'ENVIRONNEMENT

SECTION TROIS – PROTECTION CONTRE LES RISQUES DE CHOCS ELECTRIQUES
19 Courants de fuite permanents et courant auxiliaire patient .16

SECTION QUATRE – PROTECTION CONTRE LES RISQUES MECANIQUES

SECTION CINQ – PROTECTION CONTRE LES DANGERS DUS AUX RAYONNEMENTS NON
DESIRES OU EXCESSIFS
SECTION SIX – PROTECTION CONTRE LES RISQUES D'IGNITION DE
MÉLANGES ANESTHÉSIQUES INFLAMMABLES

SECTION SEPT – PROTECTION CONTRE LES TEMPÉRATURES EXCESSIVES ET
LES AUTRES RISQUES
44 Débordements, renversements, fuites, humidité, pénétration de liquides, nettoyage,
stérilisation, désinfection et compatibilité .16

SECTION HUIT – PRECISION DES CARACTERISTIQUES DE FONCTIONNEMENT ET
PROTECTION CONTRE LES CARACTÉRISTIQUES DE SORTIE PRESENTANT DES
RISQUES
51 Protection contre les caractéristiques de sortie présentant des risques .18

SECTION NEUF – FONCTIONNEMENT ANORMAL ET CONDITIONS DE DÉFAUT;
ESSAIS D’ENVIRONNEMENT
SECTION DIX – REGLES DE CONSTRUCTION
59 Construction et montage.22

Annexes.24

60601-2-39 © IEC:2003 – 3 –
CONTENTS
FOREWORD.5

SECTION ONE – GENERAL
1 Scope and object .9

2 Terminology and definitions .11

3 General requirements.13

4 General requirements for tests .13

6 Identification, marking and documentation .13

SECTION TWO – ENVIRONMENTAL CONDITIONS

SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
19 Continuous leakage current and patient auxiliary currents.17

SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS

SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES

SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization,
disinfection and compatibility.17

SECTION EIGHT – ACCURACY OF OPERATING DATA AND PROTECTION AGAINST
HAZARDOUS OUTPUT
51 Protection against hazardous output .19

SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;

ENVIRONMENTAL TESTS
SECTION TEN – CONSTRUCTION REQUIREMENTS
59 Construction and layout .23

Annexes.25

– 4 – 60601-2-39 © CEI:2003
COMMISSION ÉLECTROTECHNIQUE INTERNATIONALE

______________
APPAREILS ÉLECTROMÉDICAUX –
Partie 2-39: Règles particulières de sécurité

pour les appareils de dialyse péritonéale

AVANT-PROPOS
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La Norme internationale CEI 60601-2-39 a été établie par le sous-comité 62D: Appareils
électromédicaux, du comité d’études 62 de la CEI: Equipements électriques dans la pratique
médicale.
Cette version bilingue (2003-12) remplace la version monolingue anglaise.
Le texte anglais de cette norme est basé sur les documents 62D/311/FDIS et 62D/326/RVD.
Le rapport de vote 62D/326/RVD donne toute information sur le vote ayant abouti à
l’approbation de
...