IEC 60601-2-39:2007

IEC 60601-2-39
Edition 2.0 2007-11
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

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IEC 60601-2-39
Edition 2.0 2007-11
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
PRICE CODE
INTERNATIONALE
Q
CODE PRIX
ICS 11.040.99 ISBN 2-8318-9464-6

– 2 – 60601-2-39 © IEC:2007
CONTENTS
FOREWORD.3

201.1 Scope, object and related standards .5

201.2 Normative references.6

201.3 Terms and definitions.7

201.4 General requirements.8

201.5 General requirements for testing of PD EQUIPMENT .8

201.6 Classification of ME EQUIPMENT and ME SYSTEMS .8
201.7 PD EQUIPMENT identification, marking and documents .8
201.8 Protection against electrical HAZARDS from PD EQUIPMENT .10
201.9 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS.10
201.10 Protection against unwanted and excessive radiation HAZARDS.10
201.11 Protection against excessive temperatures and other HAZARDS.11
201.12 Accuracy of controls and instruments and protection against hazardous
outputs.11
201.13 HAZARDOUS SITUATIONS and fault conditions.13
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .13
201.15 Construction of ME EQUIPMENT .13
201.16 ME SYSTEMS .13
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .13
202 Electromagnetic compatibility – Requirements and tests .13
203 General requirements for radiation protection in diagnostic X-ray equipment.14
206 Usability.14
208 * General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems.14
209 Requirements for the reduction of environmental impacts.14
210 Process requirements for the development of physiologic closed-loop
controllers .14

Annexes .15

Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures.15
Annex AA (informative) Particular guidance and rationale.16

Index of defined terms used in this particular standard.17

60601-2-39 © IEC:2007 – 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
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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
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3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
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4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
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between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
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
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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 second edition cancels and replaces the first edition of IEC 60601-2-39. It constitutes a
technical revision. Major changes since the last edition include a summary of additional
essential performance requirements.
The text of this particular standard is based on the following documents:
Enquiry draft Report on voting
62D/555/CDV 62D/638/RVC
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.

– 4 – 60601-2-39 © IEC:2007
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

In this standard, 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 standard, 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 standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this collateral standard are by number only.
In this standard, 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 standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– 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 collateral standard will remain unchanged
until the maintenance result date indicated on the IEC web site 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.
60601-2-39 © IEC:2007 – 5 –
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 International Standard 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 standard are not covered by specific requirements in this standard except in
7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
This standard 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 2 of this particular standard.
The requirements of IEC 60601-1-3 and IEC 60601-1-8 do not apply to this standard.

– 6 – 60601-2-39 © IEC:2007
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements

contained in the general standard 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 is referred to in this particular standard as the general standard.

Collateral standards are referred to by their document number.
The numbering of sections, clauses and subclauses of this particular standard corresponds to
that of the general standard with the prefix “201” (e.g. 201.1 in this standard 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 or figures which are additional to those of the general standard are numbered
starting from 201.101, additional annexes are lettered AA, BB, etc., and additional items aa),
bb), etc.
Subclauses or figures which are additional to those of a collateral standard are numbered
starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-
1-2, 203 for IEC 60601-1-3, etc.
The term "this standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.

Where there is no corresponding section, clause or subclause in this particular standard, the
section, 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.
201.2 Normative references
Clause 2 of the general standard applies, except as follows:
Addition:
60601-2-39 © IEC:2007 – 7 –
IEC 60601-1-9:2007, Medical electrical equipment – Part 1-9: General requirements for basic

safety and essential performance – Collateral Standard: Requirements for environmentally

conscious design
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

201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005
apply, except as follows:
NOTE An index of defined terms is found beginning on page 17.
Addition:
201.3.201
APD ME EQUIPMENT
ME EQUIPMENT used to perform AUTOMATED PERITONEAL DIALYSIS (APD)
201.3.202
AUTOMATED PERITONEAL DIALYSIS (APD)
a method to perform dialysis with automated fluid exchanges in the peritoneum
201.3.203
DIALYSING SOLUTION
a pharmaceutical preparation (solution), according to the relevant pharmacopoeia monograph,
for use with PD EQUIPMENT
201.3.204
DIALYSING SOLUTION CIRCUIT
part of the fluid circuit that conveys DIALYSING SOLUTION from the PD EQUIPMENT to the
peritoneal cavity of the PATIENT, and subsequently to a drainage bag or drain, or parts
permanently and conductively connected to the fluid circuit
NOTE This is an APPLIED PART.
201.3.205
INFLOW
phase during which the peritoneal cavity is filled
NOTE The term “fill” is commonly used as a synonym for “inflow”.

201.3.206
OUTFLOW
phase during which the peritoneal cavity is emptied
NOTE 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
201.3.208
PERITONEAL DIALYSIS ME EQUIPMENT (PD EQUIPMENT)
ME EQUIPMENT used to perform PERITONEAL DIALYSIS including APD ME EQUIPMENT

– 8 – 60601-2-39 © IEC:2007
201.3.209
PROTECTIVE SYSTEM
automatic system, or a constructional feature, specifically designed to protect the PATIENT

against HAZARDS which can arise

201.4 General requirements
Clause 4 of the general standard applies, except as follows:

201.4.3 ESSENTIAL PERFORMANCE
Additional subclause:
201.4.3.101 Additional ESSENTIAL PERFORMANCE requirements
Additional ESSENTIAL PERFORMANCE requirements:
– DIALYSING SOLUTION flow to the patient;
– DIALYSING SOLUTION flow from the patient;
– temperature of dialysate;
– adherence to and accuracy of the volume balancing (inflow/outflow volume).
201.4.7 SINGLE FAULT CONDITION for ME EQUIPMENT
Additional subclause:
201.4.7.101 NORMAL CONDITION and SINGLE FAULT CONDITION for PD EQUIPMENT
PROTECTIVE SYSTEM. Example of SINGLE FAULT CONDITION: failure of a
Failure of any
PROTECTIVE SYSTEM (see 201.12.4.101, 201.12.4.103, 201.12.4.104)
201.5 General requirements for testing of PD EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.4 Other conditions
Addition:
aa) When the outcome of a test can 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.
bb) If temperatures of storage and transport conditions can influence normal use shortly after
transport, this shall be addressed by the RISK MANAGEMENT PROCESS.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies.
201.7 PD EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:

60601-2-39 © IEC:2007 – 9 –
201.7.9 ACCOMPANYING DOCUMENTS

201.7.9.1 General
Addition:
The ACCOMPANYING DOCUMENTS shall additionally include

– a statement that protective measures should be taken to prevent back syphonage of the

outflow path. Example: A statement pointing out the importance of an air gap between the

DIALYSING SOLUTION circuit and the drain in order to prevent back syphonage of the

OUTFLOW path.
NOTE Since the drainage of the fluid is normally connected by the patient it is the responsibility of the
manufacturer to warn the patient of the need for back syphonage protection and the patient’s responsibility to
ensure that it is done correctly.
201.7.9.2 Instructions for use
Additional subclause:
201.7.9.2.101
The instructions for use shall additionally include the following:
a) a description of the method(s) by which any necessary disinfection or sterilization is
achieved;
b) a statement that the test procedure by which the effectiveness of any sterilization or
disinfection has been verified is available on request;
c) a statement which draws the OPERATOR's attention to the HAZARDS associated with the
connection and disconnection of the PATIENT;
d) an explanation of the OPERATOR’s actions required to respond to alarm(s) from any
PROTECTIVE SYSTEM;
e) a list of recommended DIALYSING SOLUTION circuits for use with the PD EQUIPMENT;
f) a statement on the possible HAZARDS associated with electromagnetic radiation which can
affect the safe operation of the ME EQUIPMENT. This statement should include examples of
typical ME EQUIPMENT which can generate such radiation and also take account of potential
conditions in domestic environments;
g) a statement of the importance of the quality of the protective earth in the installation when
CLASS I ME EQUIPMENT is used;
h) a statement of the applications in which a POTENTIAL EQUALIZATION CONDUCTOR should be
used;
i) a statement that draws the OPERATOR’s attention to potential HAZARDS arising from
improper installation and connection of the DIALYSING FLUID circuit;
j) a statement that draws the OPERATOR’s attention to potential HAZARDS relating to
inappropriate selection of the DIALYSING SOLUTION.
k) descriptions about the behaviours of PD EQUIPMENT out of the NORMAL USE condition defined
in its specification.
Compliance is checked by inspection.
201.7.9.3 Technical description
Additional subclause:
– 10 – 60601-2-39 © IEC:2007
201.7.9.3.101 The technical description shall additionally include the following:

a) the particular measures or conditions to be observed when installing the PD EQUIPMENT or

bringing it into use, including guidance on the type and number of tests to be carried out;

b) the type and accuracy of the PROTECTIVE SYSTEM required in 201.12.4.101;

c) the time by which the audible alarm required in 201.12.4.101 b) may be delayed;

d) the audible alarm silence period;

e) the range of sound pressure levels of any adjustable audible alarm;

f) the maximum positive and/or negative pressures that can be generated by any pumps

used to assist the transfer of DIALYSING SOLUTION to and/or from the peritoneal cavity of

the PATIENT
g) NOTE The manufacturer shall specify where and how the maximum pressure was obtained.
h) the method and the sensitivity employed for the PROTECTIVE SYSTEM required by
201.12.4.103;
i) the method and the sensitivity employed for the PROTECTIVE SYSTEM required by
201.12.4.104.
Compliance is checked by inspection.
201.8 Protection against electrical HAZARDS from PD EQUIPMENT
Clause 8 of the general standard applies, except as follows:
201.8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
201.8.7.4 Measurements
201.8.7.4.7 Measurement of the PATIENT LEAKAGE CURRENT
Amendment:
Delete item h).
Addition:
aa) The point of measurement shall be where the DIALYSING SOLUTION circuit connects to a
peritoneal catheter. For the duration of the test, DIALYSING SOLUTION shall be flowing in the
DIALYSING SOLUTION circuit. The PD EQUIPMENT shall be fully equipped for the intended use,
as specified by the manufacturer.

201.9 Protection against mechanical hazards of ME EQUIPMENT and
ME SYSTEMS
Clause 9 of the general standard applies.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies.

60601-2-39 © IEC:2007 – 11 –
201.11 Protection against excessive temperatures and other HAZARDS

Clause 11 of the general standard applies, except as follows:

201.11.6 Overflow, spillage, leakage, ingress of liquids, cleaning, disinfection,

sterilization, and compatibility with substances used with the ME

EQUIPMENT
201.11.6.1 General
Addition:
All the provisions of 11.6.2 to 11.6.4 shall be applied using the DIALYSING SOLUTION.
201.11.6.3 Spillage on ME EQUIPMENT and ME SYSTEMS
Replacement:
The PD EQUIPMENT shall be so constructed, that in the event of spillage of liquids from the fluid
reservoir or DIALYSING SOLUTION circuit set when positioned for NORMAL USE, no HAZARDOUS
CONDITION shall result.
Compliance is checked by the following test.
With the PD EQUIPMENT placed in the position of NORMAL USE, 3 l of DIALYSING SOLUTION shall
be poured onto the top surface of the PD EQUIPMENT. The solution shall be poured
continuously over a period of 15 s.
Immediately after the test, inspection shall show that the DIALYSING SOLUTION which might
have entered the PD EQUIPMENT has not wetted parts which might cause a HAZARD. In case of
doubt, the PD EQUIPMENT shall be subjected to the dielectric strength test described in 8.8.3 of
the general standard, and the PD EQUIPMENT shall function as intended.
201.12 Accuracy of controls and instruments and protection against
hazardous outputs
Clause 12 of the general standard applies, except as follows:
201.12.4 Protection against hazardous output

Additional subclauses:
201.12.4.101 DIALYSING SOLUTION temperature
a) If the PD EQUIPMENT includes a means of heating the DIALYSING SOLUTION, the PD
EQUIPMENT shall be provided with a PROTECTIVE SYSTEM, independent of any temperature
control system, which prevents the DIALYSING SOLUTION from reaching a temperature
greater than 41°C measured at the patient end of the applied part. This measurement may

– 12 – 60601-2-39 © IEC:2007
be taken at an alternative location but shall be demonstrated to be less that 41°C at the

point of infusion to the patient.

NOTE It is not practical to measure the temperature at the patient connection.

b) The operation of the PROTECTIVE SYSTEM shall achieve the following safe conditions:

DIALYSING SOLUTION flow to the PATIENT;
– stopping of the
– activation of an audible and visual alarm.

NOTE The audible alarm may be delayed, as specified by the manufacturer.

Compliance is checked by measuring the temperature of the DIALYSING SOLUTION at the
PATIENT end of the APPLIED PART. The test shall be carried out under the most unfavourable
flow conditions.
201.12.4.102 Pressures
If the PD EQUIPMENT includes a pump designed to assist delivery of the DIALYSING SOLUTION to
the peritoneal cavity of the PATIENT, the pump shall be prevented from generating a positive
pressure that exceeds the maximum specified by the manufacturer.
If the PD EQUIPMENT includes a pump designed to assist the drainage of the used DIALYSING
SOLUTION from the PATIENT, then the pump shall be prevented from generating a negative
pressure that exceeds the maximum specified by the manufacturer.
NOTE Excessive pressures can cause damage to the peritoneum.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS and by functional
tests.
201.12.4.103 Air infusion
a) If the PD EQUIPMENT includes a pump designed to assist delivery of the DIALYSING SOLUTION
to the peritoneal cavity of the PATIENT, the PD EQUIPMENT shall be provided with a
PROTECTIVE SYSTEM that prevents pumping enough air into the peritoneal cavity to cause a
HAZARD.
NOTE Small volumes of air, such as individual bubbles in the DIALYSING SOLUTION, are not regarded as a
HAZARD in PERITONEAL DIALYSIS.
b) The operation of the PROTECTIVE SYSTEM shall either stop air from entering the APPLIED
PART, or achieve the following safe conditions:
– stopping of the pump;
– activation of an audible and visual alarm.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS and by functional
tests.
201.12.4.104 DIALYSING SOLUTION overfill
a) The PD EQUIPMENT shall be provided with a PROTECTIVE SYSTEM which prevents excessive
fluid being delivered to the peritoneal cavity and causing a HAZARD.
b) The operation of the PROTECTIVE SYSTEM shall achieve the following safe conditions:
– stopping of the DIALYSING SOLUTION flow to the PATIENT;
– activation of an audible and visual alarm.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS and by functional
tests.
60601-2-39 © IEC:2007 – 13 –
201.12.4.105 PROTECTIVE SYSTEMS

Any failure of the PROTECTIVE SYSTEMS required by this particular standard shall become
obvious to the OPERATOR at the beginning of the treatment.

Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS and by functional
tests.
201.13 HAZARDOUS SITUATIONS and fault conditions

Clause 13 of the general standard applies.
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
Clause 14 of the general standard applies.
201.15 Construction of ME EQUIPMENT
Clause 15 of the general standard applies, except as follows:
Addition:
201.15.4.101 DIALYSING SOLUTION circuit guides
If an incorrect installation of the DIALYSING SOLUTION circuit can cause a HAZARD to the
PATIENT, means shall be provided to ensure the correct attachment of the DIALYSING SOLUTION
circuit to the PD EQUIPMENT.
Compliance is checked by inspection.
201.15.4.102 OUTFLOW
OUTFLOW shall be available at all times during a therapy.
NOTE From time to time during the procedure it might be necessary to restrict the outflow for short periods of
time to complete certain steps such as set-up and prime before the patient is connected.
Compliance is checked by functional tests.

201.16 ME SYSTEMS
Clause 16 of the general standard applies.
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
Clause 17 of the general standard applies.
202 Electromagnetic compatibility – Requirements and tests
IEC 60601-1-2:2007 applies, except as follows:

– 14 – 60601-2-39 © IEC:2007
202.3.18
Addition:
NOTE A PD EQUIPMENT is not considered to be a LIFE-SUPPORTING EQUIPMENT or SYSTEM as defined in 3.18 of

IEC 60601-1-2:2007, since a premature termination of the dialysis treatment is not likely to lead to serious injury or

death of a PATIENT
203 General requirements for radiation protection in diagnostic X-ray

equipment
IEC 60601-1-3:2008 does not apply.
206 Usability
IEC 60601-1-6:2006 applies.
208 * General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems
IEC 60601-1-8:2006 does not apply.
209 Requirements for the reduction of environmental impacts
IEC 60601-1-9:2007 applies.
210 Process requirements for the development of physiologic closed-loop
controllers
IEC 60601-1-10:2007 applies.
60601-2-39 © IEC:2007 – 15 –
Annexes
The annexes of the general standard apply, except as follows:

Annex G
(normative)
Protection against HAZARDS of ignition

of flammable anaesthetic mixtures

Annex G of the general standard does not apply.

– 16 – 60601-2-39 © IEC:2007
Annex AA
(informative)
Particular guidance and rationale

The following is the rationale for a specific clause in this particular standard, with the clause

number parallel to that in the body of the document.

Clause 208 General requirements, tests and guidance for alarm systems in medical

electrical equipment and medical electrical systems
PD EQUIPMENT is in most cases used in the home environment. As the use in intensive care
environments is very rare, the alarm systems for home care use need a different focus, as
written in IEC 60601-1-8.
60601-2-39 © IEC:2007 – 17 –
Index of defined terms used in this particular standard

ACCOMPANYING DOCUMENT .IEC 60601-1:2005, 3.4

APD ME EQUIPMENT . 3.201

APPLIED PART.IEC 60601-1:2005, 3.8

AUTOMATED PERITONEAL DIALYSIS (APD). 3.202

BASIC SAFETY. IEC 60601-1:2005, 3.10

CLASS I . IEC 60601-1:2005, 3.13

DIALYSING SOLUTION . 3.203

DIALYSING SOLUTION CIRCUIT. 3.204
ESSENTIAL PERFORMANCE . IEC 60601-1:2005, 3.27
HAZARD . IEC 60601-1:2005, 3.39
HAZARDOUS SITUATIONS . IEC 60601-1:2005, 3.40
INFLOW . 3.205
LEAKAGE CURRENT. IEC 60601-1:2005, 3.47
MEDICAL ELECTRICAL EQUIPMENT (ME EQUIPMENT). IEC 60601-1:2005, 3.63
MEDICAL ELECTRICAL SYSTEM (ME SYSTEM) . IEC 60601-1:2005, 3.64
NORMAL CONDITION. IEC 60601-1:2005, 3.70
NORMAL USE. IEC 60601-1:2005, 3.71
OPERATOR . IEC 60601-1:2005, 3.73
OUTFLOW . 3.206
PATIENT . IEC 60601-1:2005, 3.76
PATIENT AUXILIARY CURRENT . IEC 60601-1:2005, 3.77
PATIENT LEAKAGE CURRENT . IEC 60601-1:2005, 3.80
PERITONEAL DIALYSIS. 3.207
PERITONEAL DIALYSIS ME EQUIPMENT. 3.208
POTENTIAL EQUALIZATION CONDUCTOR. IEC 60601-1:2005, 3.86
PROGRAMMABLE ELECTRICAL MEDICAL SYSTEM (PEMS) . IEC 60601-1:2005, 3.90
PROTECTIVE SYSTEM . 3.209
SINGLE FAULT CONDITION. IEC 60601-1:2005, 3.116

___________
– 18 – 60601-2-39 © CEI:2007
SOMMAIRE
AVANT-PROPOS.19

201.1 Domaine d'application, objet et normes connexes .22

201.2 Références normatives.23

201.3 Termes et définitions.24

201.4 Exigences générales.25

201.5 Exigences générales relatives aux essais des APPAREILS DP.25

201.6 Classification des APPAREILS EM et des SYSTÈMES EM .26
201.7 Identification, marquage et documentation des APPAREILS DP.26
201.8 Protection contre les DANGERS d'origine électrique provenant des APPAREILS DP .27
201.9 Protection contre les dangers mécaniques des APPAREILS EM et SYSTÈMES EM.28
201.10 Protection contre les DANGERS dus aux rayonnements involontaires ou
excessifs.28
201.11 Protection contre les températures excessives et les autres DANGERS .28
201.12 Précision des commandes, des instruments et protection contre les
caractéristiques de sortie dangereuses .28
201.13 SITUATIONS DANGEREUSES et conditions de défaut .30
201.14 SYSTÈMES ÉLECTROMÉDICAUX PROGRAMMABLES (SEMP) .30
201.15 Construction de L’APPAREIL EM.30
201.16 SYSTÈMES EM.30
201.17 Compatibilité électromagnétique des APPAREILS EM et des SYSTÈMES EM .30
202 Compatibilité électromagnétique – Exigences et essais.31
203 Exigences générales pour la radioprotection dans les appareils à
rayonnement X de diagnostic .31
206 Aptitude à l’utilisation .31
208 * Exigences générales, essais et guide pour les systèmes d’alarme des
appareils et des systèmes électromédicaux.31
209 Exigences pour une conception éco-responsable .31
210 Exigences pour le développement des régulateurs physiologiques en boucle
fermée .31

Annexes .32
Annexe G (normative) Protection contre les DANGERS d’inflammation des mélanges
anesthésiques inflammables .32
Annex AA (informative) Guide général et justifications .33

Index des termes définis dans la présente norme particulière .34
...