IEC 60601-2-39:2018
(Main)Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
IEC 60601-2-39:2018 applies to the basic safety and essential performance of peritoneal dialysis medical electrical equipment. It applies to peritoneal dialysis equipment intended for use either by medical staff or under the supervision of medical experts, including peritoneal dialysis equipment operated by the patient, regardless of whether the peritoneal dialysis equipment is used in a hospital or domestic environment. This third edition cancels and replaces the second edition of IEC 60601-2-39. It constitutes a technical revision.This edition includes the following significant technical changes with respect to the previous edition:
- 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;
- editorial improvements;
- improvement of the essential performance requirements clause/subclauses;
- new requirements for the interruption of the power supply.
Appareils électromédicaux - Partie 2-39: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de dialyse péritonéale
L'IEC 60601-2-39:2018 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.
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IEC 60601-2-39 ®
Edition 3.0 2018-04
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 2-39: Particular requirements for basic safety and essential performance of
peritoneal dialysis equipment
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IEC 60601-2-39 ®
Edition 3.0 2018-04
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 2-39: Particular requirements for basic safety and essential performance of
peritoneal dialysis equipment
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.99 ISBN 978-2-8322-5590-2
– 2 – IEC 60601-2-39:2018 RLV © 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 . 11
201.5 General requirements for testing ME EQUIPMENT . 14
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 14
201.7 PD ME EQUIPMENT identification, marking and documents . 14
201.8 Protection against electrical HAZARDS from PD ME EQUIPMENT . 16
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 . 20
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 20
202 Electromagnetic compatibility disturbances – Requirements and tests . 20
202.8 Electromagnetic IMMUNITY requirements for ME EQUIPMENT and ME SYSTEMS . 20
203 General requirements for radiation protection in diagnostic X-ray equipment .
206 Usability .
208 * General requirements, tests and guidance for ALARM SYSTEMS in MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS . 21
209 Requirements for the reduction of environmental impacts environmentally
conscious design . 22
210 Process requirements for the development of physiologic closed-loop controllers .
211 Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL
SYSTEMS used in the HOME HEALTHCARE ENVIRONMENT . 22
Annexes . 24
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures . 25
Annex AA (informative) Particular guidance and rationale . 26
Bibliography . 27
Index of defined terms used in this particular standard . 28
Table 201.101 – ESSENTIAL PERFORMANCE requirements . 11
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
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This redline version of the official IEC Standard allows the user to identify the changes
made to the previous edition. A vertical bar appears in the margin wherever a change
has been made. Additions are in green text, deletions are in strikethrough red text.
– 4 – IEC 60601-2-39:2018 RLV © IEC 2018
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;
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.
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.
IMPORTANT – The “colour inside” logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct understanding
of its contents. Users should therefore print this publication using a colour printer.
– 6 – IEC 60601-2-39:2018 RLV © 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.
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.
– 8 – IEC 60601-2-39:2018 RLV © IEC 2018
The requirements of IEC 60601-1-3 and IEC 60601-1-8 do not apply to this standard.
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.
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 60601-1-9:2007, 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
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, except as
follows.
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 28.
Addition:
– 10 – IEC 60601-2-39:2018 RLV © IEC 2018
201.3.201
APD ME EQUIPMENT
ME EQUIPMENT used to perform AUTOMATED PERITONEAL DIALYSIS (APD)
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
a pharmaceutical preparation (solution), according to the relevant pharmacopoeia monograph,
for use with PD EQUIPMENT
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.
201.3.204
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 HAZARDS which can arise HAZARDOUS SITUATIONS
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
Addition:
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).
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.
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 Some ESSENTIAL PERFORMANCES listed in Table 201.101 are dependent on the characteristics of the
disposables.
201.4.3.102 * DIALYSING SOLUTION flow rate during INFLOW/OUTFLOW
The accuracy of the DIALYSING SOLUTION flow rate delivered by the PD EQUIPMENT during
INFLOW/OUTFLOW to and from the PATIENT shall be as specified by the MANUFACTURER.
NOTE A DIALYSING SOLUTION flow rate during INFLOW/OUTFLOW lower than the set value is considered detrimental
for a typical treatment.
Compliance is checked under the following test conditions:
– 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.
– 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. The flow restrictor may for
example be a 60 cm silicone tube of 2,67 mm inner diameter.
– 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.
– 12 – IEC 60601-2-39:2018 RLV © IEC 2018
– 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 5 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 5 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 5 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 5 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.
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 of the PD EQUIPMENT shall be
achieved as specified by the MANUFACTURER.
NOTE 1 A DIALYSING SOLUTION volume imbalance larger than the set value is considered as more negative for a
typical treatment.
Compliance is checked under the following test conditions:
Test for APD ME 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. The flow restrictor may for
example be a 60 cm silicone tube of 2,67 mm inner diameter.
– 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.
– Measure the DIALYSING SOLUTION volume of 5 INFLOW and OUTFLOW phases, respectively,
by recording the weight of the simulated PATIENT 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.
– Measure the DIALYSING SOLUTION volume of 5 INFLOW and OUTFLOW phases, respectively,
by recording the weight of the simulated PATIENT at the start and the end of each phase.
– Set the PD EQUIPMENT to the minimum fill volume or cycle volume.
– 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.
– Measure the DIALYSING SOLUTION volume of 5 INFLOW and OUTFLOW phases, respectively,
by recording the weight of the simulated PATIENT 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 maximum allowable height, as specified by the MANUFACTURER.
– Measure the DIALYSING SOLUTION volume of 5 INFLOW and OUTFLOW phases, respectively,
by recording the weight of the simulated PATIENT at the start and the end of each phase.
NOTE 2 For tidal PD EQUIPMENT, use a partially filled simulated PATIENT fluid bag.
The values of the DIALYSING SOLUTION volume accuracies shall be within the tolerances
specified by the MANUFACTURER in the instructions for use.
201.4.3.104 PERITONEAL DIALYSIS dwell time
The accuracy of the dialysis dwell time for the PD EQUIPMENT shall be as specified by the
MANUFACTURER.
Compliance is checked by functional tests relevant for the definition of dialysis dwell time
specified by the MANUFACTURER.
201.4.3.105 DIALYSING SOLUTION composition
The test method for accuracy of the composition of the DIALYSING SOLUTION shall be specified
by the MANUFACTURER and compliance checked accordingly.
NOTE This test does not apply to PD EQUIPMENT using pre-manufactured DIALYSING SOLUTION in bags.
201.4.3.106 DIALYSING SOLUTION temperature
The DIALYSING SOLUTION temperature of the PD EQUIPMENT shall be achieved as specified by
the MANUFACTURER.
NOTE This test applies only to PD EQUIPMENT having a heater for the DIALYSING SOLUTION.
Compliance is checked under the following test conditions:
– Let the PD EQUIPMENT run until it is in a thermally stable condition.
– The environmental temperature is within 20 °C to 25 °C.
– Set the DIALYSING SOLUTION temperature to 37 °C, if applicable.
– Set the PD EQUIPMENT to operate until all DIALYSING SOLUTION processing components are
primed.
– Set the highest DIALYSING SOLUTION flow.
– Connect the PD EQUIPMENT to an appropriately sized empty fluid bag simulating the
PATIENT's peritoneal cavity ("simulated PATIENT").
– Measure the temperature at the simulated PATIENT inlet.
– Record the temperature during 5 INFLOW phases.
– Set the lowest DIALYSING SOLUTION flow.
– Measure the temperature at the simulated PATIENT inlet.
– 14 – IEC 60601-2-39:2018 RLV © IEC 2018
– Record the temperature during 5 INFLOW phases.
The values of the DIALYSING SOLUTION temperature shall be within the tolerances specified by
the MANUFACTURER in the instructions for use.
201.4.7 SINGLE FAULT CONDITION for ME EQUIPMENT
Addition:
201.4.7.101 NORMAL CONDITION and SINGLE FAULT CONDITION for PD ME EQUIPMENT
Failure of any PROTECTIVE SYSTEM. Example of SINGLE FAULT CONDITION: failure of a
PROTECTIVE SYSTEM (see 201.12.4.4.101, 201.12.4.4.102, 201.12.4.4.103, 201.12.4.4.104,
201.12.4.4.105).
201.5 General requirements for testing of PD ME 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
MANUFACTURER.
than 4 °C or the minimum temperature specified by the
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 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
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 101 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 101 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 Additional requirements regarding PD EQUIPMENT
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 upon 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 signals 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 SOLUTION 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 of the instructions for use.
201.7.9.3 Technical description
Additional subclause:
201.7.9.3.101 Additional requirements regarding PD EQUIPMENT
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 201.12.4.4.101;
c) the time by which the audible auditory ALARM SIGNAL required in 201.12.4.4.101 b) and
201.12.4.4.105 b) may be delayed;
d) the audible alarm silence AUDIO PAUSED period;
e) the range of sound pressure levels of any adjustable audible auditory ALARM SIGNAL;
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;
g) the method and the sensitivity employed for the PROTECTIVE SYSTEM required by
201.12.4.4.103;
h) the method and the sensitivity employed for the PROTECTIVE SYSTEM required by
201.12.4.4.104.
– 16 – IEC 60601-2-39:2018 RLV © IEC 2018
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
201.8 Protection against electrical HAZARDS from PD ME 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.
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 water or particular matter,
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
DIALYSING SOLUTION CIRCUIT set when positioned for NORMAL USE, no HAZARDOUS
reservoir or
CONDITION SITUATION 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 or the
maximum volume present in the fluid reservoir and DIALYSING SOLUTION CIRCUIT (whichever is
smaller) 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 HAZARDOUS
SITUATION. 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.
201.11.8 * Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT
Addition:
a) PD EQUIPMENT without INTERNAL ELECTRICAL POWER SOURCE for backup, or with INTERNAL
ELECTRICAL POWER SOURCE for operation:
In the event of an interruption of the power supply / SUPPLY MAINS to the PD EQUIPMENT, the
following safe conditions shall be achieved:
– activation of an auditory ALARM SIGNAL, lasting for at least 1 min, if the DIALYZING
SOLUTION flow to or from the PATIENT is not stopped completely;
– additional measures may be needed as determined by the MANUFACTURER'S RISK
MANAGEMENT PROCESS;
– the PD EQUIPMENT may restart automatically on restoration of the power supply only if
this does not cause any HAZARDOUS SITUATION to the PATIENT as determined by the
MANUFACTURER'S RISK MANAGEMENT PROCESS.
Compliance is checked by inspection of the RISK MANAGEMENT FILE and by functional tests.
b) PD EQUIPMENT with INTERNAL ELECTRICAL POWER SOURCE for backup:
In the event of an interruption of the power supply / SUPPLY MAINS to the PD EQUIPMENT, the
following safe conditions shall be achieved:
– activation of a visual ALARM SIGNAL;
– in case of external powered operation, activation of an auditory ALARM SIGNAL after a
time interval specified by the MANUFACTURER;
– additional measures may be needed as determined by the MANUFACTURER'S RISK
MANAGEMENT PROCESS;
– if functions of the PD EQUIPMENT were stopped in the event of an interruption of the
power supply they may restart automatically on restoration of the power supply only if
this does not cause any HAZARDOUS SITUATION to the PATIENT as determ
...
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
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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
– 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
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,
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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
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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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6) All users should ensure that they have the latest edition of this publication.
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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 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;
– 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.
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.
– 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.
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.
– 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.
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
– 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 PERFORMANCE
Addition:
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.
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 Some ESSENTIAL PERFORMANCES listed in Table 201.101 are dependent on the characteristics of the
disposables.
201.4.3.102 * DIALYSING SOLUTION flow rate during INFLOW/OUTFLOW
The accuracy of the DIALYSING SOLUTION flow rate delivered by the PD EQUIPMENT during
INFLOW/OUTFLOW to and from the PATIENT shall be as specified by the MANUFACTURER.
NOTE A DIALYSING SOLUTION flow rate during INFLOW/OUTFLOW lower than the set value is considered detrimental
for a typical treatment.
Compliance is checked under the following test conditions:
– 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.
– 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. The flow restrictor may for
example be a 60 cm silicone tube of 2,67 mm inner diameter.
– 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 5 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 5 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 5 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.
– 12 – IEC 60601-2-39:2018 © IEC 2018
– Measure the DIALYSING SOLUTION flow during 5 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.
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 of the PD EQUIPMENT shall be
achieved as specified by the MANUFACTURER.
NOTE 1 A DIALYSING SOLUTION volume imbalance larger than the set value is considered as more negative for a
typical treatment.
Compliance is checked under the following test conditions:
Test for APD ME 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
MANUFACTURER'S recommendation. The flow restrictor may for
according to the
example be a 60 cm silicone tube of 2,67 mm inner diameter.
– 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.
DIALYSING SOLUTION volume of 5 INFLOW and OUTFLOW phases, respectively,
– Measure the
by recording the weight of the simulated PATIENT 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.
– Measure the DIALYSING SOLUTION volume of 5 INFLOW and OUTFLOW phases, respectively,
by recording the weight of the simulated PATIENT at the start and the end of each phase.
PD EQUIPMENT to the minimum fill volume or cycle volume.
– Set the
– 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.
– Measure the DIALYSING SOLUTION volume of 5 INFLOW and OUTFLOW phases, respectively,
by recording the weight of the simulated PATIENT at the start and the end of each phase.
– Place the simulated PATIENT on a weighing scale located 50 cm below the PD EQUIPMENT,
MANUFACTURER.
or at the maximum allowable height, as specified by the
– Measure the DIALYSING SOLUTION volume of 5 INFLOW and OUTFLOW phases, respectively,
by recording the weight of the simulated PATIENT at the start and the end of each phase.
NOTE 2 For tidal PD EQUIPMENT, use a partially filled simulated PATIENT fluid bag.
The values of the DIALYSING SOLUTION volume accuracies shall be within the tolerances
specified by the MANUFACTURER in the instructions for use.
201.4.3.104 PERITONEAL DIALYSIS dwell time
The accuracy of the dialysis dwell time for the PD EQUIPMENT shall be as specified by the
MANUFACTURER.
Compliance is checked by functional tests relevant for the definition of dialysis dwell time
specified by the MANUFACTURER.
201.4.3.105 DIALYSING SOLUTION composition
The test method for accuracy of the composition of the DIALYSING SOLUTION shall be specified
by the MANUFACTURER and compliance checked accordingly.
NOTE This test does not apply to PD EQUIPMENT using pre-manufactured DIALYSING SOLUTION in bags.
201.4.3.106 DIALYSING SOLUTION temperature
The DIALYSING SOLUTION temperature of the PD EQUIPMENT shall be achieved as specified by
the MANUFACTURER.
NOTE This test applies only to PD EQUIPMENT having a heater for the DIALYSING SOLUTION.
Compliance is checked under the following test conditions:
– Let the PD EQUIPMENT run until it is in a thermally stable condition.
– The environmental temperature is within 20 °C to 25 °C.
– Set the DIALYSING SOLUTION temperature to 37 °C, if applicable.
– Set the PD EQUIPMENT to operate until all DIALYSING SOLUTION processing components are
primed.
– Set the highest DIALYSING SOLUTION flow.
– Connect the PD EQUIPMENT to an appropriately sized empty fluid bag simulating the
PATIENT's peritoneal cavity ("simulated PATIENT").
– Measure the temperature at the simulated PATIENT inlet.
– Record the temperature during 5 INFLOW phases.
– Set the lowest DIALYSING SOLUTION flow.
– Measure the temperature at the simulated PATIENT inlet.
– Record the temperature during 5 INFLOW phases.
The values of the DIALYSING SOLUTION temperature shall be within the tolerances specified by
the MANUFACTURER in the instructions for use.
201.4.7 SINGLE FAULT CONDITION for ME EQUIPMENT
Addition:
201.4.7.101 NORMAL CONDITION and SINGLE FAULT CONDITION for ME EQUIPMENT
Failure of any PROTECTIVE SYSTEM. Example of SINGLE FAULT CONDITION: failure of a
PROTECTIVE SYSTEM (see 201.12.4.4.101, 201.12.4.4.102, 201.12.4.4.103, 201.12.4.4.104,
201.12.4.4.105).
201.5 General requirements for testing ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
– 14 – IEC 60601-2-39:2018 © IEC 2018
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 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
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 101 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 101 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 Additional requirements regarding PD EQUIPMENT
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 upon 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 signals 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 SOLUTION 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 of the instructions for use.
201.7.9.3 Technical description
Additional subclause:
201.7.9.3.101 Additional requirements regarding PD EQUIPMENT
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 201.12.4.4.101;
c) the time by which the auditory ALARM SIGNAL required in 201.12.4.4.101 b) and
201.12.4.4.105 b) may be delayed;
d) the AUDIO PAUSED period;
e) the range of sound pressure levels of any adjustable auditory ALARM SIGNAL;
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; the MANUFACTURER shall specify where and how the maximum pressure was
obtained;
g) the method and the sensitivity employed for the PROTECTIVE SYSTEM required by
201.12.4.4.103;
h) the method and the sensitivity employed for the PROTECTIVE SYSTEM required by
201.12.4.4.104.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
201.8 Protection against electrical HAZARDS from ME 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:
– 16 – IEC 60601-2-39:2018 © IEC 2018
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.
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 water or particular matter, 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
SITUATION 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 or the
maximum volume present in the fluid reservoir and DIALYSING SOLUTION CIRCUIT (whichever is
smaller) 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 HAZARDOUS
SITUATION. 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.
201.11.8 * Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT
Addition:
a) PD EQUIPMENT without INTERNAL ELECTRICAL POWER SOURCE for backup, or with INTERNAL
ELECTRICAL POWER SOURCE for operation:
In the event of an interruption of the power supply / SUPPLY MAINS to the PD EQUIPMENT, the
following safe conditions shall be achieved:
– activation of an auditory ALARM SIGNAL, lasting for at least 1 min, if the DIALYZING
SOLUTION flow to or from the PATIENT is not stopped completely;
– additional measure
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