IEC 60601-2-16:2025

IEC 60601-2-16 ®
Edition 6.0 2025-01
REDLINE VERSION
INTERNATIONAL
STANDARD
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 6.0 2025-01
REDLINE VERSION
INTERNATIONAL
STANDARD
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 978-2-8327-0127-0
– 2 – IEC 60601-2-16:2025 RLV © IEC 2025
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 . 19
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 19
201.7 ME EQUIPMENT identification, marking and documents . 19
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 24
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 25
201.10 Protection against unwanted and excessive radiation HAZARDS . 25
201.11 Protection against excessive temperatures and other HAZARDS . 25
201.12 * Accuracy of controls and instruments and protection against hazardous
outputs . 28
201.13 Hazardous situations and fault conditions for ME EQUIPMENT . 41
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 42
201.15 Construction of ME EQUIPMENT . 44
201.16 * ME SYSTEMS . 45
201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 46
202 Electromagnetic disturbances – Requirements and tests . 46
208 General requirements, tests and guidance for ALARM SYSTEMS in MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS . 46
209 Requirements for environmentally conscious design . 49
210 Requirements for the development of PHYSIOLOGIC CLOSED-LOOP
CONTROLLERS . 49
211 * Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL
SYSTEMS used in the HOME HEALTHCARE ENVIRONMENT . 49
Annexes . 50
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures . 51
Annex AA (informative) Particular guidance and rationale . 52
Annex BB (informative) Examples of HAZARDS, foreseeable sequences of events, and
HAZARDOUS SITUATIONS in HAEMODIALYSIS EQUIPMENT . 81
Annex CC (informative) Example of an open alarm interface specification . 94
Bibliography . 98
Index of defined terms used in this document . 101

Figure 201.101 – Continuous Air infusion test setup with example dimensions . 37
Figure AA.1 – Powered by SUPPLY MAINS only . 63
Figure AA.2 – Alarm at depletion of battery for limited functionality . 63
Figure AA.3 – Alarm before battery for limited functionality gets depleted
(30 min maximum) . 64

Figure AA.4 – Alarm before battery for limited functionality gets depleted (battery
lasting for equal or less than 30 min) . 64
Figure AA.5 – Alarm at battery depletion . 65
Figure AA.6 – Alarm before battery gets depleted (30 min maximum) . 65
Figure AA.7 – DIALYSIS FLUID composition test cases for determining the ALARM SIGNAL

activation . 67
Figure AA.8 – Example of a HAEMODIALYSIS ME SYSTEM . 76
Figure CC.1 – Simplified circuit diagram . 95

ESSENTIAL PERFORMANCE requirements . 15
Table 201.101 –
Table AA.1 – Example of ALARM CONDITION priorities according to 6.1.2 of
IEC 60601‑1‑8:2006, IEC 60601‑1‑8:2006/AMD1:2012 and
IEC 60601‑1‑8:2006/AMD2:2020, adapted for HAEMODIALYSIS EQUIPMENT needs . 79
Table BB.1 – Example of HAZARDOUS SITUATIONS list following ISO 14971:20072019,
Annex EC . 82
Table CC.1 – Periodic functional check of the INPUT INTERFACE . 96
Table CC.2 – Reaction of HAEMODIALYSIS EQUIPMENT . 96
Table CC.3 – Signal result of signal input to INTERNAL SIGNAL PROCESSING unit . 96
Table CC.4 – Reaction of HAEMODIALYSIS EQUIPMENT during the treatment . 97

– 4 – IEC 60601-2-16:2025 RLV © IEC 2025
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
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
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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) IEC draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). IEC takes no position concerning the evidence, validity or applicability of any claimed patent rights in
respect thereof. As of the date of publication of this document, IEC had not received notice of (a) patent(s), which
may be required to implement this document. However, implementers are cautioned that this may not represent
the latest information, which may be obtained from the patent database available at https://patents.iec.ch. IEC
shall not be held responsible for identifying any or all such patent rights.
This redline version of the official IEC Standard allows the user to identify the changes
made to the previous edition IEC 60601-2-16:2018. A vertical bar appears in the margin
wherever a change has been made. Additions are in green text, deletions are in
strikethrough red text.
IEC 60601-2-16 has been prepared by subcommittee 62D: Particular medical equipment,
software, and systems, of IEC technical committee 62: Medical equipment, software, and
systems. It is an International Standard.
This sixth edition cancels and replaces the fifth edition published in 2018. 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, IEC 60601‑1:2005/AMD1:2012 and
IEC 60601‑1:2005/AMD2:2020, of references to IEC 60601‑1‑2:2014 and
IEC 60601‑1‑2:2014/AMD1:2020, of references to IEC 60601‑1‑8:2006,
IEC 60601‑1‑8:2006/AMD1:2012 and IEC 60601‑1‑8:2006/AMD2:2020, of references to
IEC 60601‑1‑9:2007, IEC 60601‑1‑9:2007/AMD1:2013 and IEC 60601‑1‑9:2007/
AMD2:2020, of references to IEC 60601‑1‑10:2007, IEC 60601‑1‑10:2007/AMD1:2013 and
IEC 60601‑1‑10:2007/AMD2:2020 and of references to IEC 60601‑1‑11:2015 and
IEC 60601‑1‑11:2015/AMD1:2020;
b) consideration of ESSENTIAL PERFORMANCE in SINGLE FAULT CONDITION regarding
IEC 60601‑1:2005/AMD1:2012/ISH1:2021;
c) including the information given in the document 62D/1771A/INF regarding 201.11.8;
d) including withdrawn IEC PAS 63023[17] as Annex CC;
e) including SECURITY (CYBERSECURITY) requirements;
f) consideration of HAEMODIALYSIS EQUIPMENT using pre-manufactured DIALYSIS FLUID bags;
g) improvements for labelling;
h) other minor technical improvements;
i) editorial improvements.
The text of this International Standard is based on the following documents:
Draft Report on voting
62D/2163/FDIS 62D/2184/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this International Standard is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/publications.
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 IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 AND
IEC 60601-1:2005/AMD2:2020, IN THIS DOCUMENT OR AS NOTED: SMALL CAPITALS.

– 6 – IEC 60601-2-16:2025 RLV © IEC 2025
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 document 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 and IEC 80601 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 document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
• reconfirmed,
• withdrawn, or
• revised.
NOTE The attention of the 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 document 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.

INTRODUCTION
The minimum safety requirements specified in this document are considered to provide for a
practical degree of safety in the operation of HAEMODIALYSIS, HAEMODIAFILTRATION and
HAEMOFILTRATION EQUIPMENT.
– 8 – IEC 60601-2-16:2025 RLV © IEC 2025
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 IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/ AMD2:2020 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. It applies to HAEMODIALYSIS EQUIPMENT intended for use either by
medical staff or under the supervision of medical experts, including HAEMODIALYSIS EQUIPMENT
operated by the PATIENT, regardless of whether the HAEMODIALYSIS 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.
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
safety requirements of such HAEMODIALYSIS EQUIPMENT concerning electrical safety and 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 [1] ),
– DIALYSERS (see ISO 8637-1 [2]),
– DIALYSIS FLUID CONCENTRATES (see ISO 23500-4 [3]),
___________
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.

– pre-manufactured DIALYSIS FLUID bags,
– DIALYSIS WATER supply systems (see ISO 23500-2 [4]),
– CENTRAL DELIVERY SYSTEMS for DIALYSIS FLUID CONCENTRATES (see ISO 23500-4 [3]),
described as systems for bulk mixing concentrate at a dialysis facility,
– equipment used to perform PERITONEAL DIALYSIS (see IEC 60601-2-39 [5]).
201.1.2 Object
Replacement:
The object of this document is to establish BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for HAEMODIALYSIS EQUIPMENT.
201.1.3 Collateral standards
Addition:
This document refers to those applicable collateral standards that are listed in Clause 2 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and
Clause 201.2 of this document.
IEC 60601‑1‑2:2014 and IEC 60601‑1‑2:2014/AMD1:2020, IEC 60601‑1‑8:2006,
IEC 60601‑1‑8:2006/AMD1:2012 and IEC 60601‑1‑8:2006/AMD2:2020, IEC 60601‑1‑10:2007,
IEC 60601‑1‑10:2007/AMD1:2013 and IEC 60601‑1‑10:2007/AMD2:2020,
IEC 60601‑1‑11:2015 and IEC 60601‑1‑11:2015/AMD1:2020 apply as modified in Clauses 202,
208, 210 and 211.
IEC 60601‑1‑3 and IEC 60601-1-12 does not apply. IEC 60601‑1‑9:2007,
IEC 60601‑1‑9:2007/AMD1:2013 and IEC 60601‑1‑9:2007/AMD2:2020 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 IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/
AMD2:2020 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 IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
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 document corresponds to that of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 with the
prefix "201" (e.g. 201.1 in this document addresses the content of Clause 1 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020) 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 document addresses the content of Clause 4 of
the IEC 60601-1-2 collateral standard, 203.4 in this document addresses the content of
Clause 4 of the IEC 60601-1-3 collateral standard, etc.). The changes to the text of

– 10 – IEC 60601-2-16:2025 RLV © IEC 2025
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are
specified by the use of the following words:
"Replacement" means that the clause or subclause of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or applicable collateral
standard is replaced completely by the text of this document.
"Addition" means that the text of this document is additional to the requirements of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or
applicable collateral standard.
"Amendment" means that the clause or subclause of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or applicable collateral
standard is amended as indicated by the text of this document.
Subclauses, figures or tables which are additional to those of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are numbered starting from
201.101. However, due to the fact that definitions in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are numbered 3.1 through
154, additional definitions in this document are numbered beginning from 201.3.201.
3.147
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 IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, any applicable collateral
standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this document, the clause or subclause
of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or
applicable collateral standard, although possibly not relevant, applies without modification;
where it is intended that any part of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 or applicable collateral standard, although possibly relevant, is
not to be applied, a statement to that effect is given in this document.
201.2 Normative references
NOTE Informative references are listed in the Bibliography.
Clause 2 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/
AMD2:2020 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 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
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 60601-1-10:2007/AMD2:2020
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 60601-1-11:2015/AMD1:2020
IEC 61672-1:2013, Electroacoustics – Sound level meters – Part 1: Specifications
ISO 3744:2010, Acoustics – Determination of sound power levels and sound energy levels of
noise sources using sound pressure – Engineering methods for an essentially free field over a
reflecting plane
ISO 23500-3:2024, Preparation and quality management of fluids for haemodialysis and related
therapies – Part 3: Water for haemodialysis and related therapies
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, IEC 60601-1-2:2014 and
IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012 and
IEC 60601-1-8:2006/AMD2:2020, IEC 60601-1-10:2007, IEC 60601-1-10:2007/AMD1:2013
and IEC 60601-1-10:2007/AMD2:2020, IEC 60601-1-11:2015 and IEC 60601-1-11:2015/
AMD1:2020, and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following
addresses:
• IEC Electropedia: available at https://www.electropedia.org/
• ISO Online browsing platform: available at https://www.iso.org/obp
NOTE Refer to section "Index of defined terms used in this particular standard" for the index of defined terms.
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.8 in Informative Annex AA Subclause 201.16 and see 201.16.6.3.
Note 2 to entry: One example of an APPLIED PART is the EXTRACORPOREAL CIRCUIT including any pre-manufactured
DIALYSIS FLUID bags, extension lines, and drain bags in a stand-alone system connected during treatment.
Note 3 to entry: Another example of an APPLIED PART is the EXTRACORPOREAL CIRCUIT including connected DIALYSIS
FLUID bags, that are online prepared before treatment without the patient connected and drain bags. During treatment
the online preparation part of the HAEMODIALYSIS EQUIPMENT is conductively disconnected.

– 12 – IEC 60601-2-16:2025 RLV © IEC 2025
Note 4 to entry: Another example of an APPLIED PART is the EXTRACORPOREAL CIRCUIT including all connected fluid
paths of the HAEMODIALYSIS EQUIPMENT and the connection to a drain during the treatment.
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
DIALYSIS FLUID to the HAEMODIALYSIS EQUIPMENT or distributes DIALYSIS FLUID
distribution as
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
aqueous fluid containing electrolytes and, usually, buffer and glucose, which is intended to
exchange solutes with blood during HAEMODIALYSIS
Note 1 to entry: The DIALYSIS FLUID could be pre-manufactured in bags as pharmaceuticals according to the relevant
pharmacopoeia monograph or be prepared by the HAEMODIALYSIS EQUIPMENT or be influenced in composition by the
HAEMODIALYSIS EQUIPMENT.
[SOURCE: ISO 23500-1:— [15], 3.15, modified – The word "dialysing fluid" has been added as
synonym, and the notes have been deleted ISO 23500-1:2024 [6], 3.15, modified – The notes
have been deleted and a new Note 1 to entry was added.]
201.3.206
DIALYSIS FLUID CONCENTRATE
substances which, when appropriately diluted or dissolved with DIALYSIS WATER, produce the
DIALYSIS FLUID
201.3.220207
DIALYSIS WATER
water that has been treated to meet the requirements of ISO 23500-3:2024 and which is suitable
for use in HAEMODIALYSIS applications, including the preparation of DIALYSIS FLUID, reprocessing
of DIALYSERS, preparation of concentrates DIALYSIS FLUID CONCENTRATE and preparation of
SUBSTITUTION FLUID for online convective therapies
Note 1 to entry: The words "water for dialysis", "permeate" and "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. ISO 23500-1:2024 [6], 3.17, modified – The note was
reworded.]
201.3.208
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.
201.3.208209
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
201.3.209210
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.
201.3.210211
* HAEMODIALYSIS EQUIPMENT
ME EQUIPMENT or ME SYSTEM used to perform at least one of the following: 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.
201.3.211212
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
201.3.212213
NET FLUID REMOVAL
fluid loss from the PATIENT
Note 1 to entry: Historically, this term was "weight loss".

– 14 – IEC 60601-2-16:2025 RLV © IEC 2025
201.3.213214
* ONLINE HDF
HAEMODIAFILTRATION PROCEDURE where the HAEMODIALYSIS EQUIPMENT produces SUBSTITUTION
FLUID for infusion from DIALYSIS FLUID for the HAEMODIAFILTRATION treatment
201.3.214215
* ONLINE HF
HAEMOFILTRATION PROCEDURE where the HAEMODIALYSIS EQUIPMENT produces the SUBSTITUTION
FLUID for infusion from DIALYSIS FLUID for the HAEMOFILTRATION treatment
201.3.215216
* PROTECTIVE SYSTEM
automatic system, or a constructional feature, specifically designed to protect the PATIENT
HAZARDOUS SITUATIONS
against
201.3.216217
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 23500-1:2024 [6], 3.4042, modified – The words "patient's blood" and
"ultrafiltration" have been replaced respectively by "EXTRACORPOREAL CIRCUIT" and "filtration" in
the definition, and the notes have has been deleted.]
201.3.217218
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.
201.3.218219
* ULTRAFILTRATION
PROCESS of fluid removal from the PATIENT'S blood across the semi-permeable membrane of the
DIALYSER
201.3.219220
VENOUS PRESSURE
pressure measured in the blood return line of the EXTRACORPOREAL CIRCUIT between the
DIALYSER connection and PATIENT CONNECTION
201.4 General requirements
Clause 4 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/
AMD2:2020 applies, except as follows:
201.4.3 * Essential performance
Additional subclauses:
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.

The behaviour of the HAEMODIALYSIS EQUIPMENT for ESSENTIAL PERFORMANCE in SINGLE FAULT
CONDITION shall be determined by the MANUFACTURER'S RISK MANAGEMENT.
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 1 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).
NOTE 2 Subclause 7.9.2.5 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/
AMD2:2020 describes requirements giving the specifications for the ESSENTIAL PERFORMANCE in the instruction for
use.
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 take into account 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 source (e.g. water) with a temperature of 37 °C ± 1 °C to the EXTRACORPOREAL
CIRCUIT;
– either set the NET FLUID REMOVAL rate to 0 ml/h or bypass the DIALYZER, or both;
– 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;
– create a pre-pump average ARTERIAL PRESSURE of –200 mmHg (± 10 mmHg);
– let the pump run for 30 min to 45 min at maximum blood flow rate;
– after this preconditioning 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 considerably decrease
in case of high negative pressures on the suction side.

– 16 – IEC 60601-2-16:2025 RLV © IEC 2025
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;
– measure the DIALYSIS FLUID flow rate over a period of 30 min ± 2 min;
– set the HAEMODIALYSIS EQUIPMENT to minimum DIALYSIS FLUID flow rate;
– measure the DIALYSIS FLUID flow rate over a period of 30 min ± 2 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. If the temperature can have an
impact on the NET FLUID REMOVAL measurement, the fluid shall have a temperature of
37 °C ± 1 °C at the arterial patient connection;
– 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 (± 10 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 (± 10 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 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;
– apply fluid
...