IEC 60601-2-16:2012

Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

IEC 60601-2-16:2012 applies to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. IEC 60601-2-16:2012 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 60601-2-16:2012 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 60601-2-16:2012 includes all electromedical equipment that is intended to deliver a haemodialysis, haemodiafiltration and haemofiltration treatment to a patient suffering from kidney failure. This fourth edition cancels and replaces the third edition of IEC 60601-2-16, published in 2008. This edition constitutes a technical revision. Changes since the previous edition include, among others, better adaptation of IEC 60601-1-8 and improvement of subclause 201.8.3.

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

La CEI 60601-2-16:2012 s'applique à la sécurité de base et aux performances essentielles des appareils d'hémodialyse, d'hémodiafiltration et d'hémofiltration. La CEI 60601-2-16:2012 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. La CEI 60601-2-16:2012 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 quatrième édition annule et remplace la troisième édition de la CEI 60601-2-16, publiée en 2008. La présente édition constitue une révision technique. Les évolutions par rapport à l'édition précédente comprennent, entre autres, une meilleure adaptation de la CEI 60601-1-8 et amélioration du paragraphe 201.8.3.

General Information

• Status: Published
• Publication Date: 07-Mar-2012
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Drafting Committee: MT 20 - TC 62/SC 62D/MT 20
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 20-Apr-2018

Relations

• Revised: IEC 60601-2-16:2018 - Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-2-16


®


Edition 4.0 2012-03



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



IEC 60601-2-16:2012

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IEC 60601-2-16



®


Edition 4.0 2012-03







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

PRICE CODE
INTERNATIONALE

XB
CODE PRIX


ICS 11.040.20;11.040.25 ISBN 978-2-8322-0042-1



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® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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CONTENTS

FOREWORD. 3


INTRODUCTION . 6

201.1 Scope, object and related standards . 7

201.2 Normative references . 9


201.3 Terms and definitions . 10

201.4 General requirements . 12

201.5 General requirements for testing of ME EQUIPMENT . 15

201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 16
201.7 ME EQUIPMENT identification, marking and documents . 16
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 19
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 20
201.10 Protection against unwanted and excessive radiation HAZARDS . 21
201.11 Protection against excessive temperatures and other HAZARDS . 21
201.12 * Accuracy of controls and instruments and protection against hazardous
outputs . 22
201.13 HAZARDOUS SITUATIONS and fault conditions . 30
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 31
201.15 Construction of ME EQUIPMENT . 31
201.16 * ME SYSTEMS . 32
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 33
202 Electromagnetic compatibility – Requirements and tests . 33
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems . 33
210 Process requirements for the development of PHYSIOLOGIC CLOSED-LOOP
CONTROLLERS . 35
211 * Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL
SYSTEMS used in the HOME HEALTHCARE ENVIRONMENT . 35
Annexes . 35
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures . 36
Annex AA (informative) Particular guidance and rationale . 37

Annex BB (informative)  Examples of HAZARDS, foreseeable sequences of events, and
HAZARDOUS SITUATIONS in HAEMODIALYSIS EQUIPMENT . 55
Bibliography . 63
Index of defined terms used in this particular standard . 64

Figure 201.101 – Continuous air infusion test set-up with example dimensions . 28
Figure AA.1 – Example of the HAEMODIALYSIS ME SYSTEM . 51

Table 201.101 – ESSENTIAL PERFORMANCE requirements . 12
Table AA.1: Possible ALARM CONDITION priorities according to 6.1.2 of
IEC 60601-1-8:2006, . 53
Table BB.1 – Hazardous situation list following ISO 14971:2007, Annex E . 55

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60601-2-16 © IEC:2012 – 3 –


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
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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 fourth edition cancels and replaces the third edition of IEC 60601-2-16, published in
2008. This edition constitutes a technical revision. Changes since the previous edition
include, among others, better adaptation of IEC 60601-1-8 and improvement of subclause
201.8.3.

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The text of this particular standard is based on the following documents:

FDIS Report on voting


62D/972/FDIS 62D/987/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 standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or

test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex AA.
A list of all parts of the IEC 60601 series, published under the general title: Medical electrical
equipment, can be found on the IEC website.

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60601-2-16 © IEC:2012 – 5 –


The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data

related to the specific publication. At this date, the publication will be


• reconfirmed,

• withdrawn,

• replaced by a revised edition, or

• amended.




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
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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.

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60601-2-16 © IEC:2012 – 7 –


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

1
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Addition:
BASIC SAFETY and ESSENTIAL PERFORMANCE of
This International Standard applies to the
HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as
HAEMODIALYSIS EQUIPMENT.
This International Standard 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
AEMODIALYSIS EQUIPMENT concerning electrical safety and PATIENT safety.
H
This International Standard 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.
This International Standard includes all ME EQUIPMENT that is intended to deliver a
HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION treatment to a PATIENT suffering
from kidney failure.
The particular requirements in this International standard do not apply to:
EXTRACORPOREAL CIRCUITS;
–
– DIALYSERS;
DIALYSIS FLUID CONCENTRATES;
–

– water treatment equipment;
PERITONEAL DIALYSIS (see IEC 60601-2-39).
– equipment used to perform
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.
AZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
H
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.
___________
1
 The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance.

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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 IEC 60601-1, and Clause 201.2 of this International Standard.
IEC 60601-1-2, IEC 60601-1-8, IEC 60601-1-10 and IEC 60601-11 apply as modified in
Clauses 202, 208, 210 and 211 respectively. IEC 60601-1-3 does not apply. 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 IEC 60601-1.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the 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 3.139, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.

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60601-2-16 © IEC:2012 – 9 –


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, e.g. 202 for

IEC 60601-1-2, 203 for IEC 60601-1-3, etc.


The term "this standard" is used to make reference to the general standard, any applicable

collateral standards and this particular standard taken together.


Where there is no corresponding, 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 beginning on page 63.
Clause 2 of the general standard applies, except as follows:
Amendment:
IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic compatibility –
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 60601-1-8:2006, 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.
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 60601-1-11:2010, 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 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 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

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201.3 Terms and definitions


For the purposes of this document, the terms and definitions given in IEC 60601-1:2005, and

IEC 60601-1-10:2007 apply, except as follows:


NOTE An index of defined terms is found beginning on page 64.


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 in Annex AA.
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
current can flow between the PATIENT and the HAEMODIALYSIS EQUIPMENT in NORMAL CONDITION or SINGLE FAULT
CONDITION.
Additions:
201.3.201
ARTERIAL PRESSURE
pressure measured in the blood withdrawal line of the EXTRACORPOREAL CIRCUIT
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 water for distribution

as DIALYSIS FLUID to the HAEMODIALYSIS EQUIPMENT or distributes DIALYSIS FLUID CONCENTRATE
201.3.204
DIALYSER
a device containing a semi-permeable membrane that is used to perform HD, HDF or HF
201.3.205
DIALYSIS FLUID
solution intended to exchange solutes and/or water with blood during HD or HDF
Note 1 to entry: The words "dialysate", “dialysis solution” and "dialysing fluid" are commonly used as synonyms of
DIALYSIS FLUID.
201.3.206
DIALYSIS FLUID CONCENTRATE
substances which, when appropriately diluted or dissolved with purified water, produce the
DIALYSIS FLUID

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60601-2-16 © IEC:2012 – 11 –


201.3.207

EXTRACORPOREAL CIRCUIT

blood lines and any integral ACCESSORY thereof


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 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 simultane
...