IEC 60601-2-16:2018
(Main)Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
IEC 60601-2-16:2018 applies to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. IEC 60601-2-16:2018 does not take into consideration the dialysis fluid control system of Haemodialysis equipment using regeneration of dialysis fluid and central delivery systems. It does however take into consideration the specific safety requirements of such haemodialysis equipment concerning electrical safety and patient safety. IEC 60601-2-16:2018 specifies the minimum safety requirements for haemodialysis equipment. These devices are intended for use either by medical staff or for use by the patient or other trained personnel under the supervision of medical expertise. IEC 60601-2-16:2018 includes all electromedical equipment that is intended to deliver a haemodialysis, haemodiafiltration and haemofiltration treatment to a patient suffering from kidney failure. This fifth edition cancels and replaces the fourth edition of IEC 60601-2-16, published in 2012. This edition includes the following significant technical changes with respect to the previous edition:
a) update of 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, of references to IEC 60601-1-9:2007 and IEC 60601-1-9:2007/AMD1:2013, of references to IEC 60601-1-10:2007 and IEC 60601-1-10:2007/AMD1:2013 and of references to IEC 60601-1-11:2015;
b) widening of the scope;
c) editorial improvements;
d) addition of requirements for anticoagulant delivery means;
e) other few small technical changes.
Appareils électromédicaux - Partie 2-16: Exigences particulières pour la sécurité de base et les performances essentielles des appareils d'hémodialyse, d'hémodiafiltration et d'hémofiltration
L'IEC 60601-2-16:2018 s'applique à la sécurité de base et aux performances essentielles des appareils d'hémodialyse, d'hémodiafiltration et d'hémofiltration. L'IEC 60601-2-16:2018 ne prend pas en compte le système de contrôle du liquide de dialyse de l'appareil d'hémodialyse utilisant la régénération du liquide de dialyse et les systèmes de transmission centralisés. Toutefois, elle prend en compte les exigences de sécurité spécifiques de l'appareil d'hémodialyse concernant la sécurité électrique et la sécurité du patient. L'IEC 60601-2-16:2018 spécifie les exigences minimales de sécurité relatives aux appareils d'hémodialyse. Ces appareils sont destinés à être utilisés soit par le personnel médical, soit par le patient, soit par d'autres personnes formées, sous le contrôle d'un personnel ayant une bonne compétence médicale. La présente Norme internationale s'applique à tout appareil electromédical destiné à fournir un traitement d'hémodialyse, d'hémodiafiltration et d'hémofiltration à un patient souffrant d'insuffisance rénale. Cette cinquième édition annule et remplace la quatrième édition de l'IEC 60601-2-16 parue en 2012. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente:
a) 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, des références à l'IEC 60601-1-9:2007 et l'IEC 60601-1-9:2007/AMD1:2013, des références à l'IEC 60601-1-10:2007 et l'IEC 60601-1-10:2007/AMD1:2013 ainsi que des références à l'IEC 60601-1-11:2015;
b) élargissement du domaine d'application;
c) améliorations d'ordre rédactionnel;
d) ajout d'exigences concernant les dispositifs de transmission d'anticoagulant;
e) quelques autres modifications techniques limitées.
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IEC 60601-2-16 ®
Edition 5.0 2018-04
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 2-16: Particular requirements for the basic safety and essential
performance of haemodialysis, haemodiafiltration and haemofiltration
equipment
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IEC 60601-2-16 ®
Edition 5.0 2018-04
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 2-16: Particular requirements for the basic safety and essential
performance of haemodialysis, haemodiafiltration and haemofiltration
equipment
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.20; 11.040.25 ISBN 978-2-8322-5624-4
– 2 – IEC 60601-2-16:2018 RLV © IEC 2018
CONTENTS
FOREWORD . 4
INTRODUCTION . 2
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions . 11
201.4 General requirements . 14
201.5 General requirements for testing ME EQUIPMENT . 18
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 18
201.7 ME EQUIPMENT identification, marking and documents . 18
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 22
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 23
201.10 Protection against unwanted and excessive radiation HAZARDS . 23
201.11 Protection against excessive temperatures and other HAZARDS . 24
201.12 * Accuracy of controls and instruments and protection against hazardous
outputs . 25
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 35
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 36
201.15 Construction of ME EQUIPMENT . 36
201.16 * ME SYSTEMS . 37
201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 38
202 Electromagnetic compatibility disturbances – Requirements and tests . 38
208 General requirements, tests and guidance for ALARM SYSTEMS in MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS . 39
209 Requirements for environmentally conscious design . 40
210 Process Requirements for the development of PHYSIOLOGIC CLOSED-LOOP
CONTROLLERS . 41
211 * Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL
SYSTEMS used in the HOME HEALTHCARE ENVIRONMENT . 41
Annexes . 43
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures . 44
Annex AA (informative) Particular guidance and rationale . 45
Annex BB (informative) Examples of HAZARDS, foreseeable sequences of events, and
HAZARDOUS SITUATIONS in HAEMODIALYSIS EQUIPMENT . 66
Bibliography . 75
Index of defined terms used in this particular standard. 78
Figure 201.101 – Continuous air infusion test setup with example dimensions . 32
Figure AA.1 – Example of a HAEMODIALYSIS ME SYSTEM . 62
Table 201.101 – ESSENTIAL PERFORMANCE requirements . 14
Table AA.1 – Possible Example of ALARM CONDITION priorities according
to 6.1.2 of IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012, adapted for
HAEMODIALYSIS EQUIPMENT needs . 64
Table BB.1 – HAZARDOUS SITUATION list following ISO 14971:2007, Annex E . 66
– 4 – IEC 60601-2-16:2018 RLV © IEC 2018
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-16: Particular requirements for the basic safety and
essential performance of haemodialysis, haemodiafiltration
and haemofiltration equipment
FOREWORD
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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.
International standard IEC 60601-2-16 has been prepared by IEC subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This fifth edition cancels and replaces the fourth edition of IEC 60601-2-16 published in 2012.
This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) update of 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, of references to
IEC 60601-1-9:2007 and IEC 60601-1-9:2007/AMD1:2013, of references to
IEC 60601-1-10:2007 and IEC 60601-1-10:2007/AMD1:2013 and of references to
IEC 60601-1-11:2015;
b) widening of the scope;
c) editorial improvements;
d) addition of requirements for anticoagulant delivery means;
e) other few small technical changes.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/1557/FDIS 62D/1585/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.
– 6 – IEC 60601-2-16:2018 RLV © IEC 2018
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.
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 document using a
colour printer.
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.
INTRODUCTION
The minimum safety requirements specified in this particular standard are considered to
provide for a practical degree of safety in the operation of HAEMODIALYSIS,
HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT.
– 8 – IEC 60601-2-16:2018 RLV © IEC 2018
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-16: Particular requirements for the basic safety and
essential performance of haemodialysis, haemodiafiltration
and haemofiltration equipment
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Addition Replacement:
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as
HAEMODIALYSIS EQUIPMENT.
This document does not take into consideration specific safety details of the DIALYSIS FLUID
control system of HAEMODIALYSIS EQUIPMENT using regeneration of DIALYSIS FLUID and or
CENTRAL DELIVERY SYSTEMS for DIALYSIS FLUID. It does, however, take into consideration the
specific safety requirements of such HAEMODIALYSIS EQUIPMENT concerning electrical safety
and PATIENT safety.
This document specifies the minimum safety requirements for HAEMODIALYSIS EQUIPMENT.
These devices HAEMODIALYSIS EQUIPMENT are intended for use either by medical staff or for
use by the PATIENT or other trained personnel under medical supervision of medical expertise.
This document includes all ME EQUIPMENT that is intended to deliver a HAEMODIALYSIS,
HAEMODIAFILTRATION and HAEMOFILTRATION treatment to a PATIENT suffering from kidney failure,
independent of the treatment duration and location.
If applicable, this document applies to the relevant parts of ME EQUIPMENT intended for other
extracorporeal blood purification treatments.
The particular requirements in this document do not apply to:
– EXTRACORPOREAL CIRCUITS (see ISO 8637-2, [12] );
– DIALYSERS (see ISO 8637-1, [11]);
– DIALYSIS FLUID CONCENTRATES (see ISO 23500-4, [18]);
– DIALYSIS WATER treatment equipment supply systems (see ISO 23500-2, [16]);
– CENTRAL DELIVERY SYSTEMS for DIALYSIS FLUID CONCENTRATES (see ISO 23500-4, [18]),
described as systems for bulk mixing concentrate at a dialysis facility;
– equipment used to perform PERITONEAL DIALYSIS (see IEC 60601-2-39, [8]).
___________
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.
Numbers in square brackets refer to the Bibliography.
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 IEC 60601-1.
NOTE See also 4.2 of IEC 60601-1:2005.
201.1.2 Object
Replacement:
The object of this particular standard is to establish BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for HAEMODIALYSIS EQUIPMENT.
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.
IEC 60601-1-2:2014, IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012, IEC 60601-1-
10:2007 and IEC 60601-1-10:2007/AMD1:2013 and IEC 60601-1-11:2015 apply as modified in
Clauses 202, 208, 210 and 211 respectively. 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 does not apply as noted in
Clause 209. All other published collateral standards in the IEC 60601-1 series apply as
published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the 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 IEC 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the
IEC 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.
– 10 – IEC 60601-2-16:2018 RLV © IEC 2018
"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 3.139147, 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:
Amendment Replacement:
IEC 60601-1-2:2007 2014, Medical electrical equipment – Part 1-2: General requirements for
basic safety and essential performance – Collateral Standard: Electromagnetic compatibility
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 60601-1-10:2007, Medical electrical equipment – Part 1-10: General requirements for
basic safety and essential performance – Collateral Standard: Requirements for the
development of physiologic closed-loop controllers
IEC 60601-1-10:2007/AMD1:2013
IEC 60601-1-11:2010 2015, Medical electrical equipment – Part 1-11: General requirements
for basic safety and essential performance – Collateral Standard: Requirements for medical
electrical equipment and medical electrical systems used in the home healthcare environment
IEC 61672-1, Electroacoustics – Sound level meters – Part 1: Specifications
IEC 62366:2007, Medical devices – Application of usability engineering to medical devices
ISO 594-2, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other
medical equipment – Part 2: Lock fittings
ISO 3744, Acoustics – Determination of sound power levels and sound energy levels of noise
sources using sound pressure – Engineering method in an essentially free field over a
reflecting plane
ISO 8638, Cardiovascular implants and artificial organs – Extracorporeal blood circuit for
haemodialysers, haemodiafilters and haemofilters
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given 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 60601-1-10:2007 and IEC 60601-1-10:2007/AMD1:2013, 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 78.
201.3.8
* APPLIED PART
Replacement:
EXTRACORPOREAL CIRCUIT and all parts permanently and conductively connected to it (e.g.
DIALYSIS FLUID circuit)
Note 1 to entry: See Figure AA.1.
201.3.78
PATIENT CONNECTION
Addition:
Note 1 to entry: The PATIENT blood lines connectors are the individual points on the APPLIED PART through which a
current can flow between the PATIENT and the HAEMODIALYSIS EQUIPMENT in NORMAL CONDITION or SINGLE FAULT
CONDITION.
Additional terms and definitions:
201.3.201
ARTERIAL PRESSURE
pressure measured in the blood withdrawal line of the EXTRACORPOREAL CIRCUIT between the
PATIENT CONNECTION and DIALYSER connection
Note 1 to entry: A difference can be made between the pre-pump pressure, which is upstream of the blood pump,
and post-pump pressure, which is downstream of the blood pump.
– 12 – IEC 60601-2-16:2018 RLV © IEC 2018
201.3.202
* BLOOD LEAK
leakage of blood from the blood compartment to the DIALYSIS FLUID compartment of the
DIALYSER
Note 1 to entry: When performing an HF PROCESS, this involves the filtration fluid section.
201.3.203
CENTRAL DELIVERY SYSTEM
part of a ME SYSTEM which proportions DIALYSIS FLUID CONCENTRATE and DIALYSIS WATER for
distribution as DIALYSIS FLUID to the HAEMODIALYSIS EQUIPMENT or distributes DIALYSIS FLUID
CONCENTRATE
201.3.204
DIALYSER
device containing a semi-permeable membrane that is used to perform HD, HDF or HF
201.3.205
DIALYSIS FLUID
DIALYSATE
DIALYSIS SOLUTION
DIALYSING FLUID
solution aqueous fluid containing electrolytes and, usually, buffer and glucose, which is
intended to exchange solutes and/or water with blood during HAEMODIALYSIS or HDF
[SOURCE: ISO 23500-1:— [15], 3.15, modified – The word "dialysing fluid" has been added as
synonym, and the notes have been deleted.]
201.3.206
DIALYSIS FLUID CONCENTRATE
substances which, when appropriately diluted or dissolved with purified DIALYSIS WATER,
produce the DIALYSIS FLUID
201.3.207
EXTRACORPOREAL CIRCUIT
blood lines, DIALYSER and any integral ACCESSORY thereof
Note 1 to entry: An alternative for DIALYSER could be a HF-filter, adsorber or other device.
201.3.208
HAEMODIAFILTRATION
HDF
PROCESS whereby concentrations of water-soluble substances in a PATIENT'S blood and an
excess of fluid of a PATIENT with renal insufficiency are corrected by a simultaneous
combination of HD and HF
201.3.209
HAEMODIALYSIS
HD
PROCESS whereby concentrations of water-soluble substances in a PATIENT'S blood and an
excess of fluid of a PATIENT with renal insufficiency are corrected by bidirectional diffusive
transport and ULTRAFILTRATION across a semi-permeable membrane separating the blood from
the DIALYSIS FLUID
Note 1 to entry: This PROCESS normally typically includes fluid removal by filtration. This PROCESS is usually also
accompanied by diffusion of substances from the DIALYSIS FLUID into the blood.
201.3.210
* HAEMODIALYSIS EQUIPMENT
ME EQUIPMENT or ME SYSTEM used to perform HAEMODIALYSIS, HAEMODIAFILTRATION and/or
HAEMOFILTRATION
Note 1 to entry: When the term ME EQUIPMENT is used in headings, it is equivalent to HAEMODIALYSIS EQUIPMENT.
When the term ME EQUIPMENT is used in the text, it is referring to a general ME EQUIPMENT.
201.3.211
HAEMOFILTRATION
HF
PROCESS whereby concentrations of water-soluble substances in a PATIENT's blood and an
excess of fluid of a PATIENT with renal insufficiency are corrected by unidirectional convective
transport via ULTRAFILTRATION across a semi-permeable membrane separating the blood from
the DIALYSIS FLUID AND ultrafiltrate is simultaneously replaced by an approximately isoosmolar
SUBSTITUTION FLUID at a rate such that the difference between the ULTRAFILTRATION rate and
the rate of SUBSTITUTION FLUID addition will lead to removal of the excess fluid over the course
of the treatment are corrected by convective transport via ULTRAFILTRATION and partial
replacement by a SUBSTITUTION FLUID resulting in the required NET FLUID REMOVAL
201.3.212
NET FLUID REMOVAL
fluid loss from the PATIENT
Note 1 to entry: Historically, this term was "weight loss".
201.3.213
* ONLINE HDF
HAEMODIAFILTRATION PROCEDURE where the HAEMODIALYSIS EQUIPMENT, based on the DIALYSIS
FLUID, produces SUBSTITUTION FLUID for infusion from DIALYSIS FLUID for the
HAEMODIAFILTRATION treatment, suitable for injection
201.3.214
* ONLINE HF
HAEMOFILTRATION PROCEDURE where the HAEMODIALYSIS EQUIPMENT, based on the DIALYSIS
FLUID, produces the SUBSTITUTION FLUID for infusion from DIALYSIS FLUID for the
HAEMOFILTRATION treatment, suitable for injection
201.3.215
* PROTECTIVE SYSTEM
automatic system, or a constructional feature, specifically designed to protect the PATIENT
against HAZARDS which can arise HAZARDOUS SITUATIONS
201.3.216
SUBSTITUTION FLUID
a fluid administered to the PATIENT via the EXTRACORPOREAL CIRCUIT during HF or HDF
fluid used in HF and HDF treatments which is directly infused into the EXTRACORPOREAL CIRCUIT
as a replacement for the fluid that is removed from the blood by filtration
[SOURCE:ISO 23500-1:—[15], 3.40, modified – The words "patient's blood" and
"ultrafiltration" have been replaced respectively by "EXTRACORPOREAL CIRCUIT" and "filtration"
in the definition, and the notes have been deleted.]
201.3.217
TRANSMEMBRANE PRESSURE
TMP
fluid pressure difference exerted across the semi-permeable membrane of the DIALYSER
Note 1 to entry: Generally the mean TMP is used. In practice, the displayed TRANSMEMBRANE PRESSURE is usually
estimated from the measured EXTRACORPOREAL CIRCUIT pressure and minus the measured DIALYSIS FLUID pressure,
each obtained at a single point.
Note 2 to entry: This note applies to the French language only.
– 14 – IEC 60601-2-16:2018 RLV © IEC 2018
201.3.218
* ULTRAFILTRATION
PROCESS of fluid removal from the PATIENT'S blood across the semi-permeable membrane of
the DIALYSER
201.3.219
VENOUS PRESSURE
pressure measured in the blood return line of the EXTRACORPOREAL CIRCUIT between the
DIALYSER connection and PATIENT CONNECTION
201.3.220
DIALYSIS WATER
water that has been treated to meet the requirements of ISO 23500-3 [17] and which is
suitable for use in HAEMODIALYSIS applications, including the preparation of DIALYSIS FLUID,
reprocessing of DIALYSERS, preparation of concentrates and preparation of SUBSTITUTION FLUID
for online convective therapies
Note 1 to entry: The words "water for dialysis", "permeate", "reverse osmosis water" and "purified water" are
commonly used as synonyms of DIALYSIS WATER.
[SOURCE: ISO 23500-1:—[15], 3.17, modified – The reference number "[17]" has been added
in the definition, as well as the note.]
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 HAEMODIALYSIS 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
Blood flow rate 201.4.3.102
DIALYSIS FLUID flow rate 201.4.3.103
NET FLUID REMOVAL 201.4.3.104
SUBSTITUTION FLUID flow rate 201.4.3.105
Dialysis time 201.4.3.106
DIALYSIS FLUID composition 201.4.3.107
DIALYSIS FLUID temperature 201.4.3.108
SUBSTITUTION FLUID temperature 201.4.3.109
NOTE Some ESSENTIAL PERFORMANCES requirements listed in Table 201.101 are dependent on the characteristics
of the disposables used (e.g. blood flow rate is dependent upon the pump segment inner diameter in rotary
peristaltic pumps).
201.4.3.102 Blood flow rate
The blood flow rate of the HAEMODIALYSIS EQUIPMENT shall be delivered as specified by the
MANUFACTURER. The specification shall include the pump segment fatigue for the maximum
specified usage life of the EXTRACORPOREAL CIRCUIT.
* NOTE 1 Only A blood flow rate lower than the set value is considered as negative detrimental for a typical
treatment. Therefore, the goal of testing is to find the highest negative blood flow rate error.
Compliance is checked under the following test conditions for typical peristaltic pumps:
– apply an unused pump segment to the HAEMODIALYSIS EQUIPMENT according to the
instructions for use and let it run for at least 30 min;
– apply a fluid (e.g. water) with a temperature of 37 °C in the EXTRACORPOREAL CIRCUIT;
– set the blood flow rate of the HAEMODIALYSIS EQUIPMENT to 400 ml/min or – if not possible –
to the highest possible blood flow rate;
– set the pre-pump ARTERIAL PRESSURE to –200 mmHg;
– measure the blood flow rate.
The value of the measured blood flow rate shall be within the tolerances specified by the
MANUFACTURER in the instructions for use.
NOTE 2 Pump segment fatigue can reduce the blood flow rate.
NOTE 3 The blood flow rate in peristaltic pumps can be affected by negative input pressures.
201.4.3.103 DIALYSIS FLUID flow rate
The DIALYSIS FLUID flow rate of the HAEMODIALYSIS EQUIPMENT shall be delivered as specified
by the MANUFACTURER.
NOTE Only A DIALYSIS FLUID flow rate lower than the set value is considered as negative detrimental for a typical
treatment.
Compliance is checked under the following test conditions:
– set the HAEMODIALYSIS EQUIPMENT to the HAEMODIALYSIS mode as specified by the
MANUFACTURER;
– set the HAEMODIALYSIS EQUIPMENT to maximum DIALYSIS FLUID flow rate;
– measure the DIALYSIS FLUID flow rate over a period of 30 min;
– set the HAEMODIALYSIS EQUIPMENT to minimum DIALYSIS FLUID flow rate;
– measure the DIALYSIS FLUID flow rate over a period of 30 min.
The values of the DIALYSIS FLUID flow rate shall be within the tolerances specified by the
MANUFACTURER in the instructions for use.
201.4.3.104 NET FLUID REMOVAL
The NET FLUID REMOVAL of the HAEMODIALYSIS EQUIPMENT shall be achieved as specified by the
MANUFACTURER.
Compliance is checked under the following test conditions.
Test 1 for the balancing part of the HAEMODIALYSIS EQUIPMENT only:
– set the HAEMODIALYSIS EQUIPMENT in the HAEMODIALYSIS mode, if applicable, with a
DIALYSER according to the MANUFACTURER’S recommendation;
– apply fluid (e.g. water) in THE EXTRACORPOREAL CIRCUIT;
– 16 – IEC 60601-2-16:2018 RLV © IEC 2018
– set the highest DIALYSIS FLUID flow rate, if applicable;
– set the DIALYSIS FLUID temperature to 37 °C, if applicable;
– set the NET FLUID REMOVAL rate to 0 ml/h or the lowest adjustable value;
– create a DIALYSER blood outlet pressure of 50 mmHg below the highest operating pressure
specified by the MANUFACTURER;
– measure the NET FLUID REMOVAL during an appropriate time interval.
Continue with test 2:
– set the NET FLUID REMOVAL rate to the maximum value;
– measure the NET FLUID REMOVAL during an appropriate time interval.
Continue with test 3:
– create a DIALYSER blood outlet pressure of 20 mmHg above the lowest operating pressure
specified by the MANUFACTURER;
– measure the NET FLUID REMOVAL during an appropriate time interval.
The values of the NET FLUID REMOVAL shall be within the tolerances specified by the
MANUFACTURER in the instructions for use.
201.4.3.105 SUBSTITUTION FLUID flow rate
For HAEMOFILTRATION and HAEMODIAFILTRATION EQUIPMENT only.
The SUBSTITUTION FLUID flow rate of the HAEMODIALYSIS EQUIPMENT shall be delivered as
specified by the MANUFACTURER.
NOTE Only A SUBSTITUTION FLUID flow rate lower than the set value is considered as negative detrimental for a
typical treatment.
Compliance is checked under the following test conditions.
Test 1 for the balancing part of the HAEMODIALYSIS EQUIPMENT and of the therapeutic relevant
SUBSTITUTION FLUID flow rate:
– set the HAEMODIALYSIS EQUIPMENT to the HDF or HF mode with a DIALYSER according to the
MANUFACTURER’s recommendation;
– apply fluid (e.g. water) in the EXTRAXCORPOREAL CIRCUIT;
– set the NET FLUID REMOVAL flow rate to 0 ml/h, or – if not possible – to the minimum;
– set the maximum SUBSTITUTION FLUID flow rate;
– set the temperature of the SUBSTITUTION FLUID to 37 °C, if applicable;
– measure the SUBSTITUTION FLUID flow rate and the NET FLUID REMOVAL.
Continue with test 2:
– set the minimum SUBSTITUTION FLUID flow rate;
– measure the SUBSTITUTION FLUID flow rate and the NET FLUID REMOVAL.
The values of SUBSTITUTION FLUID flow rate and NET FLUID REMOVAL shall be within the
tolerances specified by the MANUFACTURER in the instructions for use.
201.4.3.106 Dialysis time
The accuracy of the dialysis treatment time for the HAEMODIALYSIS EQUIPMENT shall be as
specified by the MANUFACTURER.
Compliance is checked by functional measurements tests relevant for the definition of dialysis
treatment time specified by the MANUFACTURER.
201.4.3.107 * DIALYSIS FLUID composition
The test method for accuracy of the composition of the DIALYSIS FLUID shall be specified by the
MANUFACTURER and compliance checked accordingly.
201.4.3.108 DIALYSIS FLUID temperature
The temperature of the DIALYSIS FLUID for the HAEMODIALYSIS EQUIPMENT shall be achieved as
specified by the MANUFACTURER.
NOTE This test applies only to HAEMODIALYSIS EQUIPMENT having a heater for the DIALYSIS FLUID.
Compliance is checked under the following test conditions:
– let the HAEMODIALYSIS EQUIPMENT run until it is in a thermally stable condition at
environmental conditions within 20 °C to 25 °C;
– set the DIALYSIS FLUID temperature to 37 °C, if applicable;
– set the highest DIALYSIS FLUID flow rate;
– measure the temperature at the DIALYSER inlet;
– record the temperature during a period of 30 min;
– set the lowest DIALYSIS FLUID flow rate;
– measure the temperature at the DIALYSER inlet;
– record the temperature during a period of 30 min.
The values of the DIALYSIS FLUID temperature shall be within the tolerances specified by the
MANUFACTURER in the instructions for use.
201.4.3.109 SUBSTITUTION FLUID temperature
The tolerances of The SUBSTITUTION FLUID temperature of the HAEMODIALYSIS EQUIPMENT shall
be achieved as specified by the MANUFACTURER.
NOTE This test applies only to HAEMODIALYSIS EQUIPMENT having a heater for the SUBSTITUTION FLUID.
Compliance is checked under the following test conditions.
– let the HAEMODIALYSIS EQUIPMENT run until it is in a thermally stable condition within the
environment;
– the environmental temperature is within 20 °C to 25 °C;
– set the SUBSTITUTION FLUID temperature to 37 °C, if applicable;
– set the highest SUBSTITUTION FLUID flow rate;
– measure the temperature of the SUBSTITUTION FLUID at the connection point of the
SUBSTITUTION FLUID line to the blood line;
– record the temperature over a period of 30 min;
– set the lowest SUBSTITUTION FLUID flow rate;
– measure the temperature of the SUBSTITUTION FLUID at the connection point of the
SUBSTITUTION FLUID line to the blood line;
– record the temperature over a period of 30 min.
The values of the SUBSTITUTION FLUID temperature shall be within the tolerances specified by
the MANUFACTURER in the instructions for use.
– 18 – IEC 60601-2-16:2018 RLV © IEC 2018
201.4.7 SINGLE FAULT CONDITION for ME EQUIPMENT
Addition:
An example of SINGLE FAULT CONDITION is a 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);
NOTE 101 If air is permanently present in the EXTRACORPOREAL CIRCUIT when the HAEMODIALYSIS EQUIPMENT is
used as intended by the MANUFACTURER, the air is not regarded as a SINGLE FAULT CONDITION, but as NORMAL
CONDITION.
201.5 General requirements for testing ME EQUIPMENT
Clause 5 of the general standard applies.
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:
201.7.4.3 Units of measurement
Addition:
mmHg may be used for measurement of pressures in any part of the HAEMODIALYSIS
.
EQUIPMENT
201.7.8.2 * Colours of controls
Replacement:
The color red may be used for a control of the blood pump function or for a control by which a
function is interrupted in case of emergency.
201.7.9.2 Instructions for use
201.7.9.2.2 Warning and safety notices
Addition:
The instructions for use shall additionally include the following, if applicable:
– a warning statement which draws the OPERATOR'S attention to the precautions necessary
to prevent any cross-infection between PATIENTS;
– a warning statement which draws the OPERATOR'S attention to the HAZARDs HAZARDOUS
SITUATION associated with connection and disconnection of the PATIENT;
– a warning statement which draws the OPERATOR'S attention to the potential HAZARDs,
including any HAZARDOUS SITUATIONS, arising from improper connections of the
EXTRACORPOREAL CIRCUIT;
– a warning statement on the HAZARDS related to incorrect choice of DIALYSIS FLUID
CONCENTRATE(S
...
IEC 60601-2-16 ®
Edition 5.0 2018-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-16: Particular requirements for the basic safety and essential performance
of haemodialysis, haemodiafiltration and haemofiltration equipment
Appareils électromédicaux –
Partie 2-16: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils d'hémodialyse, d'hémodiafiltration et d'hémofiltration
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IEC 60601-2-16 ®
Edition 5.0 2018-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-16: Particular requirements for the basic safety and essential performance
of haemodialysis, haemodiafiltration and haemofiltration equipment
Appareils électromédicaux –
Partie 2-16: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils d'hémodialyse, d'hémodiafiltration et d'hémofiltration
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.20; 11.040.25 ISBN 978-2-8322-5549-0
– 2 – IEC 60601-2-16:2018 © IEC 2018
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions . 11
201.4 General requirements . 14
201.5 General requirements for testing ME EQUIPMENT . 17
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 17
201.7 ME EQUIPMENT identification, marking and documents . 17
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 22
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 23
201.10 Protection against unwanted and excessive radiation HAZARDS . 23
201.11 Protection against excessive temperatures and other HAZARDS . 23
201.12 * Accuracy of controls and instruments and protection against hazardous
outputs . 24
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 34
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 34
201.15 Construction of ME EQUIPMENT . 35
201.16 * ME SYSTEMS . 35
201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 36
202 Electromagnetic disturbances – Requirements and tests . 36
208 General requirements, tests and guidance for ALARM SYSTEMS in MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS . 37
209 Requirements for environmentally conscious design . 39
210 Requirements for the development of PHYSIOLOGIC CLOSED-LOOP
CONTROLLERS . 39
211 * Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL
SYSTEMS used in the HOME HEALTHCARE ENVIRONMENT . 39
Annexes . 41
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures . 42
Annex AA (informative) Particular guidance and rationale . 43
Annex BB (informative) Examples of HAZARDS, foreseeable sequences of events, and
HAZARDOUS SITUATIONS in HAEMODIALYSIS EQUIPMENT . 62
Bibliography . 71
Index of defined terms used in this particular standard. 74
Figure 201.101 – Continuous air infusion test setup with example dimensions . 30
Figure AA.1 – Example of a HAEMODIALYSIS ME SYSTEM . 58
Table 201.101 – ESSENTIAL PERFORMANCE requirements . 14
Table AA.1 – Example of ALARM CONDITION priorities according to 6.1.2
of IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012, adapted for
HAEMODIALYSIS EQUIPMENT needs . 60
Table BB.1 – HAZARDOUS SITUATION list following ISO 14971:2007, Annex E . 62
– 4 – IEC 60601-2-16:2018 © IEC 2018
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-16: Particular requirements for the basic safety and
essential performance of haemodialysis, haemodiafiltration
and haemofiltration equipment
FOREWORD
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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 60601-2-16 has been prepared by IEC subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This fifth edition cancels and replaces the fourth edition of IEC 60601-2-16 published in 2012.
This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) update of 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, of references to
IEC 60601-1-9:2007 and IEC 60601-1-9:2007/AMD1:2013, of references to
IEC 60601-1-10:2007 and IEC 60601-1-10:2007/AMD1:2013 and of references to
IEC 60601-1-11:2015;
b) widening of the scope;
c) editorial improvements;
d) addition of requirements for anticoagulant delivery means;
e) other few small technical changes.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/1557/FDIS 62D/1585/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.
– 6 – IEC 60601-2-16:2018 © IEC 2018
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.
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 document using a
colour printer.
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.
INTRODUCTION
The minimum safety requirements specified in this particular standard are considered to
provide for a practical degree of safety in the operation of HAEMODIALYSIS,
HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT.
– 8 – IEC 60601-2-16:2018 © IEC 2018
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-16: Particular requirements for the basic safety and
essential performance of haemodialysis, haemodiafiltration
and haemofiltration 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
HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as
HAEMODIALYSIS EQUIPMENT.
This document does not take into consideration specific safety details of the DIALYSIS FLUID
control system of HAEMODIALYSIS EQUIPMENT using regeneration of DIALYSIS FLUID or CENTRAL
DELIVERY SYSTEMS for DIALYSIS FLUID. It does, however, take into consideration the specific
HAEMODIALYSIS EQUIPMENT concerning electrical safety and
safety requirements of such
PATIENT safety.
This document specifies the minimum safety requirements for HAEMODIALYSIS EQUIPMENT.
These HAEMODIALYSIS EQUIPMENT are intended for use either by medical staff or for use by the
PATIENT or other trained personnel under medical supervision.
This document includes all ME EQUIPMENT that is intended to deliver a HAEMODIALYSIS,
HAEMODIAFILTRATION and HAEMOFILTRATION treatment to a PATIENT, independent of the
treatment duration and location.
If applicable, this document applies to the relevant parts of ME EQUIPMENT intended for other
extracorporeal blood purification treatments.
The particular requirements in this document do not apply to:
– EXTRACORPOREAL CIRCUITS (see ISO 8637-2, [12] );
– DIALYSERS (see ISO 8637-1, [11]);
– DIALYSIS FLUID CONCENTRATES (see ISO 23500-4, [18]);
– DIALYSIS WATER supply systems (see ISO 23500-2, [16]);
– CENTRAL DELIVERY SYSTEMS for DIALYSIS FLUID CONCENTRATES (see ISO 23500-4, [18]),
described as systems for bulk mixing concentrate at a dialysis facility;
– equipment used to perform PERITONEAL DIALYSIS (see IEC 60601-2-39, [8]).
___________
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.
Numbers in square brackets refer to the Bibliography.
201.1.2 Object
Replacement:
The object of this particular standard is to establish BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for HAEMODIALYSIS EQUIPMENT.
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.
IEC 60601-1-2:2014, IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012,
IEC 60601-1-10:2007 and IEC 60601-1-10:2007/AMD1:2013 and IEC 60601-1-11:2015 apply
as modified in Clauses 202, 208, 210 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 does not apply as noted in
Clause 209. All other published collateral standards in the IEC 60601-1 series apply as
published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the 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 IEC 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the
IEC 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
– 10 – IEC 60601-2-16:2018 © IEC 2018
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 60601-1-10:2007, Medical electrical equipment – Part 1-10: General requirements for
basic safety and essential performance – Collateral Standard: Requirements for the
development of physiologic closed-loop controllers
IEC 60601-1-10:2007/AMD1:2013
IEC 60601-1-11:2015, Medical electrical equipment – Part 1-11: General requirements for
basic safety and essential performance – Collateral Standard: Requirements for medical
electrical equipment and medical electrical systems used in the home healthcare environment
IEC 61672-1, Electroacoustics – Sound level meters – Part 1: Specifications
ISO 3744, Acoustics – Determination of sound power levels and sound energy levels of noise
sources using sound pressure – Engineering method in an essentially free field over a
reflecting plane
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given 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 60601-1-10:2007 and IEC 60601-1-10:2007/AMD1:2013, 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 74.
201.3.8
* APPLIED PART
Replacement:
EXTRACORPOREAL CIRCUIT and all parts permanently and conductively connected to it (e.g.
DIALYSIS FLUID circuit)
Note 1 to entry: See Figure AA.1.
201.3.78
PATIENT CONNECTION
Addition:
Note 1 to entry: The PATIENT blood lines connectors are the individual points on the APPLIED PART through which a
current can flow between the PATIENT and the HAEMODIALYSIS EQUIPMENT in NORMAL CONDITION or SINGLE FAULT
CONDITION.
Additional terms and definitions:
201.3.201
ARTERIAL PRESSURE
pressure measured in the blood withdrawal line of the EXTRACORPOREAL CIRCUIT between the
PATIENT CONNECTION and DIALYSER connection
Note 1 to entry: A difference can be made between the pre-pump pressure, which is upstream of the blood pump,
and post-pump pressure, which is downstream of the blood pump.
201.3.202
* BLOOD LEAK
leakage of blood from the blood compartment to the DIALYSIS FLUID compartment of the
DIALYSER
Note 1 to entry: When performing an HF PROCESS, this involves the filtration fluid section.
201.3.203
CENTRAL DELIVERY SYSTEM
part of a ME SYSTEM which proportions DIALYSIS FLUID CONCENTRATE and DIALYSIS WATER for
distribution as DIALYSIS FLUID to the HAEMODIALYSIS EQUIPMENT or distributes DIALYSIS FLUID
CONCENTRATE
201.3.204
DIALYSER
device containing a semi-permeable membrane that is used to perform HD, HDF or HF
– 12 – IEC 60601-2-16:2018 © IEC 2018
201.3.205
DIALYSIS FLUID
DIALYSATE
DIALYSIS SOLUTION
DIALYSING FLUID
aqueous fluid containing electrolytes and, usually, buffer and glucose, which is intended to
exchange solutes with blood during HAEMODIALYSIS
[SOURCE: ISO 23500-1:— [15], 3.15, modified – The word "dialysing fluid" has been added as
synonym, and the notes have been deleted.]
201.3.206
DIALYSIS FLUID CONCENTRATE
substances which, when appropriately diluted or dissolved with DIALYSIS WATER, produce the
DIALYSIS FLUID
201.3.207
EXTRACORPOREAL CIRCUIT
blood lines, DIALYSER and any integral ACCESSORY
Note 1 to entry: An alternative for DIALYSER could be a HF-filter, adsorber or other device.
201.3.208
HAEMODIAFILTRATION
HDF
PROCESS whereby concentrations of water-soluble substances in a PATIENT'S blood and an
excess of fluid of a PATIENT are corrected by a simultaneous combination of HD and HF
201.3.209
HAEMODIALYSIS
HD
PROCESS whereby concentrations of water-soluble substances in a PATIENT'S blood and an
excess of fluid of a PATIENT are corrected by bidirectional diffusive transport and
ULTRAFILTRATION across a semi-permeable membrane separating the blood from the DIALYSIS
FLUID
Note 1 to entry: This PROCESS typically includes fluid removal by filtration. This PROCESS is usually also
accompanied by diffusion of substances from the DIALYSIS FLUID into the blood.
201.3.210
* HAEMODIALYSIS EQUIPMENT
ME EQUIPMENT or ME SYSTEM used to perform HAEMODIALYSIS, HAEMODIAFILTRATION and/or
HAEMOFILTRATION
Note 1 to entry: When the term ME EQUIPMENT is used in headings, it is equivalent to HAEMODIALYSIS EQUIPMENT.
When the term ME EQUIPMENT is used in the text, it is referring to a general ME EQUIPMENT.
201.3.211
HAEMOFILTRATION
HF
PROCESS whereby concentrations of water-soluble substances in a PATIENT'S blood and an
excess of fluid of a PATIENT are corrected by convective transport via ULTRAFILTRATION and
partial replacement by a SUBSTITUTION FLUID resulting in the required NET FLUID REMOVAL
201.3.212
NET FLUID REMOVAL
fluid loss from the PATIENT
Note 1 to entry: Historically, this term was "weight loss".
201.3.213
* ONLINE HDF
HAEMODIAFILTRATION PROCEDURE where the HAEMODIALYSIS EQUIPMENT produces SUBSTITUTION
FLUID for infusion from DIALYSIS FLUID for the HAEMODIAFILTRATION treatment
201.3.214
* ONLINE HF
HAEMOFILTRATION PROCEDURE where the HAEMODIALYSIS EQUIPMENT produces the SUBSTITUTION
FLUID for infusion from DIALYSIS FLUID for the HAEMOFILTRATION treatment
201.3.215
* PROTECTIVE SYSTEM
automatic system, or a constructional feature, specifically designed to protect the PATIENT
HAZARDOUS SITUATIONS
against
201.3.216
SUBSTITUTION FLUID
fluid used in HF and HDF treatments which is directly infused into the EXTRACORPOREAL CIRCUIT
as a replacement for the fluid that is removed from the blood by filtration
[SOURCE:ISO 23500-1:—[15], 3.40, modified – The words "patient's blood" and
"ultrafiltration" have been replaced respectively by "EXTRACORPOREAL CIRCUIT" and "filtration"
in the definition, and the notes have been deleted.]
201.3.217
TRANSMEMBRANE PRESSURE
TMP
fluid pressure difference exerted across the semi-permeable membrane of the DIALYSER
Note 1 to entry: Generally the mean TMP is used. In practice, the displayed TRANSMEMBRANE PRESSURE is usually
estimated from the measured EXTRACORPOREAL CIRCUIT pressure minus the measured DIALYSIS FLUID pressure,
each obtained at a single point.
Note 2 to entry: This note applies to the French language only.
201.3.218
* ULTRAFILTRATION
PROCESS of fluid removal from the PATIENT'S blood across the semi-permeable membrane of
the DIALYSER
201.3.219
VENOUS PRESSURE
pressure measured in the blood return line of the EXTRACORPOREAL CIRCUIT between the
DIALYSER connection and PATIENT CONNECTION
201.3.220
DIALYSIS WATER
water that has been treated to meet the requirements of ISO 23500-3 [17] and which is
suitable for use in HAEMODIALYSIS applications, including the preparation of DIALYSIS FLUID,
reprocessing of DIALYSERS, preparation of concentrates and preparation of SUBSTITUTION FLUID
for online convective therapies
Note 1 to entry: The words "water for dialysis", "permeate", "reverse osmosis water" and "purified water" are
commonly used as synonyms of DIALYSIS WATER.
[SOURCE: ISO 23500-1:—[15], 3.17, modified – The reference number "[17]" has been added
in the definition, as well as the note.]
– 14 – IEC 60601-2-16:2018 © IEC 2018
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
ESSENTIAL PERFORMANCE of HAEMODIALYSIS EQUIPMENT includes, but is not
If applicable, the
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
Blood flow rate 201.4.3.102
DIALYSIS FLUID flow rate 201.4.3.103
NET FLUID REMOVAL 201.4.3.104
SUBSTITUTION FLUID flow rate 201.4.3.105
Dialysis time 201.4.3.106
DIALYSIS FLUID composition 201.4.3.107
DIALYSIS FLUID temperature 201.4.3.108
SUBSTITUTION FLUID temperature 201.4.3.109
NOTE Some ESSENTIAL PERFORMANCE requirements listed in Table 201.101 are dependent on the characteristics
of the disposables used (e.g. blood flow rate is dependent upon the pump segment inner diameter in rotary
peristaltic pumps).
201.4.3.102 Blood flow rate
The blood flow rate of the HAEMODIALYSIS EQUIPMENT shall be delivered as specified by the
MANUFACTURER. The specification shall include the pump segment fatigue for the maximum
specified usage life of the EXTRACORPOREAL CIRCUIT.
* NOTE 1 A blood flow rate lower than the set value is considered detrimental for a typical treatment. Therefore,
the goal of testing is to find the highest negative blood flow rate error.
Compliance is checked under the following test conditions for typical peristaltic pumps:
– apply an unused pump segment to the HAEMODIALYSIS EQUIPMENT according to the
instructions for use and let it run for at least 30 min;
– apply a fluid (e.g. water) with a temperature of 37 °C in the EXTRACORPOREAL CIRCUIT;
– set the blood flow rate of the HAEMODIALYSIS EQUIPMENT to 400 ml/min or – if not possible –
to the highest possible blood flow rate;
– set the pre-pump ARTERIAL PRESSURE to –200 mmHg;
– measure the blood flow rate.
The value of the measured blood flow rate shall be within the tolerances specified by the
MANUFACTURER in the instructions for use.
NOTE 2 Pump segment fatigue can reduce the blood flow rate.
NOTE 3 The blood flow rate in peristaltic pumps can be affected by negative input pressures.
201.4.3.103 DIALYSIS FLUID flow rate
The DIALYSIS FLUID flow rate of the HAEMODIALYSIS EQUIPMENT shall be delivered as specified
by the MANUFACTURER.
NOTE A DIALYSIS FLUID flow rate lower than the set value is considered detrimental for a typical treatment.
Compliance is checked under the following test conditions:
– set the HAEMODIALYSIS EQUIPMENT to the HAEMODIALYSIS mode as specified by the
MANUFACTURER;
– set the HAEMODIALYSIS EQUIPMENT to maximum DIALYSIS FLUID flow rate;
DIALYSIS FLUID flow rate over a period of 30 min;
– measure the
– set the HAEMODIALYSIS EQUIPMENT to minimum DIALYSIS FLUID flow rate;
DIALYSIS FLUID flow rate over a period of 30 min.
– measure the
The values of the DIALYSIS FLUID flow rate shall be within the tolerances specified by the
MANUFACTURER in the instructions for use.
201.4.3.104 NET FLUID REMOVAL
The NET FLUID REMOVAL of the HAEMODIALYSIS EQUIPMENT shall be achieved as specified by the
MANUFACTURER.
Compliance is checked under the following test conditions.
Test 1 for the balancing part of the HAEMODIALYSIS EQUIPMENT only:
– set the HAEMODIALYSIS EQUIPMENT in the HAEMODIALYSIS mode, if applicable, with a
DIALYSER according to the MANUFACTURER’S recommendation;
– apply fluid (e.g. water) in THE EXTRACORPOREAL CIRCUIT;
– set the highest DIALYSIS FLUID flow rate, if applicable;
– set the DIALYSIS FLUID temperature to 37 °C, if applicable;
– set the NET FLUID REMOVAL rate to 0 ml/h or the lowest adjustable value;
– create a DIALYSER blood outlet pressure of 50 mmHg below the highest operating pressure
specified by the MANUFACTURER;
– measure the NET FLUID REMOVAL during an appropriate time interval.
Continue with test 2:
– set the NET FLUID REMOVAL rate to the maximum value;
– measure the NET FLUID REMOVAL during an appropriate time interval.
Continue with test 3:
– create a DIALYSER blood outlet pressure of 20 mmHg above the lowest operating pressure
specified by the MANUFACTURER;
– measure the NET FLUID REMOVAL during an appropriate time interval.
NET FLUID REMOVAL shall be within the tolerances specified by the
The values of the
MANUFACTURER in the instructions for use.
201.4.3.105 SUBSTITUTION FLUID flow rate
For HAEMOFILTRATION and HAEMODIAFILTRATION EQUIPMENT only.
– 16 – IEC 60601-2-16:2018 © IEC 2018
The SUBSTITUTION FLUID flow rate of the HAEMODIALYSIS EQUIPMENT shall be delivered as
specified by the MANUFACTURER.
NOTE A SUBSTITUTION FLUID flow rate lower than the set value is considered detrimental for a typical treatment.
Compliance is checked under the following test conditions.
Test 1 for the balancing part of the HAEMODIALYSIS EQUIPMENT and of the therapeutic relevant
SUBSTITUTION FLUID flow rate:
– set the HAEMODIALYSIS EQUIPMENT to the HDF or HF mode with a DIALYSER according to the
MANUFACTURER’s recommendation;
EXTRACORPOREAL CIRCUIT;
– apply fluid (e.g. water) in the
– set the NET FLUID REMOVAL flow rate to 0 ml/h, or – if not possible – to the minimum;
SUBSTITUTION FLUID flow rate;
– set the maximum
– set the temperature of the SUBSTITUTION FLUID to 37 °C, if applicable;
– measure the SUBSTITUTION FLUID flow rate and the NET FLUID REMOVAL.
Continue with test 2:
– set the minimum SUBSTITUTION FLUID flow rate;
– measure the SUBSTITUTION FLUID flow rate and the NET FLUID REMOVAL.
SUBSTITUTION FLUID flow rate and NET FLUID REMOVAL shall be within the
The values of
tolerances specified by the MANUFACTURER in the instructions for use.
201.4.3.106 Dialysis time
The accuracy of the dialysis treatment time for the HAEMODIALYSIS EQUIPMENT shall be as
specified by the MANUFACTURER.
Compliance is checked by functional tests relevant for the definition of dialysis treatment time
specified by the MANUFACTURER.
201.4.3.107 * DIALYSIS FLUID composition
The test method for accuracy of the composition of the DIALYSIS FLUID shall be specified by the
MANUFACTURER and compliance checked accordingly.
IALYSIS FLUID temperature
201.4.3.108 D
The temperature of the DIALYSIS FLUID shall be achieved as specified by the MANUFACTURER.
NOTE This test applies only to HAEMODIALYSIS EQUIPMENT having a heater for the DIALYSIS FLUID.
Compliance is checked under the following test conditions:
– let the HAEMODIALYSIS EQUIPMENT run until it is thermally stable at environmental conditions
within 20 °C to 25 °C;
– set the DIALYSIS FLUID temperature to 37 °C, if applicable;
– set the highest DIALYSIS FLUID flow rate;
– measure the temperature at the DIALYSER inlet;
– record the temperature during a period of 30 min;
– set the lowest DIALYSIS FLUID flow rate;
– measure the temperature at the DIALYSER inlet;
– record the temperature during a period of 30 min.
The values of the DIALYSIS FLUID temperature shall be within the tolerances specified by the
MANUFACTURER in the instructions for use.
201.4.3.109 SUBSTITUTION FLUID temperature
The SUBSTITUTION FLUID temperature of the HAEMODIALYSIS EQUIPMENT shall be achieved as
specified by the MANUFACTURER.
NOTE This test applies only to HAEMODIALYSIS EQUIPMENT having a heater for the SUBSTITUTION FLUID.
Compliance is checked under the following test conditions.
– let the HAEMODIALYSIS EQUIPMENT run until it is in a thermally stable condition within the
environment;
– the environmental temperature is within 20 °C to 25 °C;
– set the SUBSTITUTION FLUID temperature to 37 °C, if applicable;
– set the highest SUBSTITUTION FLUID flow rate;
– measure the temperature of the SUBSTITUTION FLUID at the connection point of the
SUBSTITUTION FLUID line to the blood line;
– record the temperature over a period of 30 min;
– set the lowest SUBSTITUTION FLUID flow rate;
– measure the temperature of the SUBSTITUTION FLUID at the connection point of the
SUBSTITUTION FLUID line to the blood line;
– record the temperature over a period of 30 min.
The values of the SUBSTITUTION FLUID 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:
An example of SINGLE FAULT CONDITION is a 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);
NOTE 101 If air is permanently present in the EXTRACORPOREAL CIRCUIT when the HAEMODIALYSIS EQUIPMENT is
used as intended by the MANUFACTURER, the air is not regarded as a SINGLE FAULT CONDITION, but as NORMAL
CONDITION.
201.5 General requirements for testing ME EQUIPMENT
Clause 5 of the general standard applies.
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:
201.7.4.3 Units of measurement
Addition:
– 18 – IEC 60601-2-16:2018 © IEC 2018
mmHg may be used for measurement of pressures in any part of the HAEMODIALYSIS
EQUIPMENT.
201.7.8.2 * Colours
...
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