Medical electrical equipment - Part 2-16: Particular requirements for the 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.

Medizinische elektrische Geräte - Teil 2-16: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Hämodialyse-, Hämodiafiltrations- und Hämofiltrationsgeräten

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.

Medicinska električna oprema - 2-16. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za kemodializo, kemodiafiltracijo in kemofiltracijo

Ta mednarodni standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI OPREME ZA KEMODIALIZO, KEMODIAFILTRACIJO IN KEMOFILTRACIJO (v nadaljevanju: OPREMA ZA KEMODIALIZO).
Ta mednarodni standard ne zajema nadzornega sistema za DIALIZNO TEKOČINO OPREME ZA KEMODIALIZO, ki uporablja regeneracijo DIALIZNE TEKOČINE in OSREDNJE SISTEME DOVAJANJA. Zajema pa specifične varnostne zahteve OPREME ZA KEMODIALIZO v povezavi z električno varnostjo in varnostjo PACIENTA. Ta mednarodni standard navaja minimalne varnostne zahteve OPREME ZA KEMODIALIZO. Te naprave so namenjene uporabi zdravniškega osebja oziroma PACIENTA ali drugega usposobljenega osebja pod nadzorom oseb s strokovnim medicinskim znanjem.
Ta mednarodni standard vključuje ELEKTROMEDICINSKO OPREMO za KEMODIALIZO, KEMODIAFILTRACIJO in KEMOFILTRACIJO, namenjeno PACIENTOM z odpovedjo ledvic.
Posebne zahteve v tem mednarodnem standardu ne veljajo za:
– ZUNAJTELESNE OBTOKE;
– DIALIZATORJE;
– KONCENTRATE DIALIZNE TEKOČINE;
– opremo za pripravo vode;
– opremo za PERITONEALNO DIALIZO (glejte standard IEC 60601-2-39).
Če je točka ali podtočka namenjena samo obravnavi ELEKTROMEDICINSKE OPREME ali ELEKTROMEDICINSKIH SISTEMOV, bo to zapisano v naslovu in vsebini točke ali podtočke. Če ni zapisano, točka ali podtočka obravnava ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME. Posebne zahteve tega standarda ne vključujejo temeljnih TVEGANJ pri nameravani fiziološki funkciji ELEKTROMEDICINSKE OPREME in SISTEMOV, ki spadajo na področje tega standarda, razen v točkah 7.2.13 in 8.4.1 standarda IEC 60601-1.

General Information

Status
Published
Publication Date
11-Jun-2015
Current Stage
6060 - Document made available
Due Date
12-Jun-2015
Completion Date
12-Jun-2015

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SLOVENSKI STANDARD
SIST EN 60601-2-16:2015
01-september-2015
Nadomešča:
SIST EN 60601-2-16:1998
Medicinska električna oprema - 2-16. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za kemodializo, kemodiafiltracijo in kemofiltracijo

Medical electrical equipment - Part 2-16: Particular requirements for basic safety and

essential performance of haemodialysis, haemodiafiltration and haemofiltration
equipment

Medizinische elektrische Geräte - Teil 2-16: Besondere Festlegungen für die Sicherheit

einschließlich der wesentlichen Leistungsmerkmale von Hämodialyse-,
Hämodiafiltrations- und Hämofiltrationsgeräten

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
Ta slovenski standard je istoveten z: EN 60601-2-16:2015
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN 60601-2-16:2015 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 60601-2-16:2015
---------------------- Page: 2 ----------------------
SIST EN 60601-2-16:2015
EUROPEAN STANDARD EN 60601-2-16
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2015
ICS 11.040.20; 11.040.25 Supersedes EN 60601-2-16:1998
English Version
Medical electrical equipment - Part 2-16: Particular requirements
for the basic safety and essential performance of haemodialysis,
haemodiafiltration and haemofiltration equipment
(IEC 60601-2-16:2012)

Appareils électromédicaux - Partie 2-16: Exigences Medizinische elektrische Geräte - Teil 2-16: Besondere

particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der

essentielles des appareils d'hémodialyse, wesentlichen Leistungsmerkmale von Hämodialyse-,

d'hémodiafiltration et d'hémofiltration Hämodiafiltrations- und Hämofiltrationsgeräten

(IEC 60601-2-16:2012) (IEC 60601-2-16:2012)

This European Standard was approved by CENELEC on 2015-04-14. CENELEC members are bound to comply with the CEN/CENELEC

Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC

Management Centre or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation

under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the

same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,

Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,

Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.

Ref. No. EN 60601-2-16:2015 E
---------------------- Page: 3 ----------------------
SIST EN 60601-2-16:2015
EN 60601-2-16:2015 (E)
Foreword

The text of document 62D/972/FDIS, future edition 4 of IEC 60601-2-16, prepared by SC 62D,

"Electromedical equipment", of IEC TC 62, "Electrical equipment in medical practice" was submitted

to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-16:2015.
The following dates are fixed:
• latest date by which the document has (dop) 2016-01-14
to be implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2018-04-14
• latest date by which the national
standards conflicting with the
document have to be withdrawn
This document supersedes EN 60601-2-16:1998.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such

patent rights.
This document has been prepared under a mandate given to CENELEC by the European

Commission and the European Free Trade Association, and supports essential requirements of EU

Directive(s).

For the relationship with EU Directive see informative Annex ZZ, which is an integral part of this

document.
Endorsement notice

The text of the International Standard IEC 60601-2-16:2012 was approved by CENELEC as a

European Standard without any modification.

In the official version, for Bibliography, the following notes have to be added for the standards

indicated:
IEC 60601-2-16:1998 NOTE Harmonized as EN 60601-2-16:1998 (not modified).
IEC 60601-2-39 NOTE Harmonized as EN 60601-2-39.
ISO 11197 NOTE Harmonized as EN ISO 11197.
---------------------- Page: 4 ----------------------
SIST EN 60601-2-16:2015
EN 60601-2-16:2015 (E)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following documents, in whole or in part, are normatively referenced in this document and are

indispensable for its application. For dated references, only the edition cited applies. For undated

references, the latest edition of the referenced document (including any amendments) applies.

NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant

EN/HD applies.

NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:

www.cenelec.eu.
Annex ZA of EN 60601-1:2006 applies with the following exceptions:
Publication Year Title EN/HD Year
Replacement :
IEC 60601-1-2 2007 Medical electrical equipment - Part 1-2: EN 60601-1-2 2007
General requirements for basic safety and
essential performance - Collateral
+ corr March 2010
standard: Electromagnetic compatibility -
Requirements and tests
IEC 60601-1-6 2010 Medical electrical equipment - Part 1-6: EN 60601-1-6 2010
General requirements for basic safety and
essential performance - Collateral
standard: Usability
IEC 60601-1-8 2006 Medical electrical equipment - Part 1-8: EN 60601-1-8 2007
General requirements for basic safety and
essential performance - Collateral
+ corr March 2010
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: EN 60601-1-10 2008
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: EN 60601-1-11 2010
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 EN 62366 2008
engineering to medical devices
---------------------- Page: 5 ----------------------
SIST EN 60601-2-16:2015
EN 60601-2-16:2015 (E)
ISO 594-2 - Conical fittings with 6 % (Luer) taper for
syringes, needles and certain other
medical equipment - Part 2: Lock fittings
ISO 3744 - Acoustics - Determination of sound power EN ISO 3744 -
levels and sound energy levels of noise
sources using sound pressure -
Engineering methods for an essentially
free field over a reflecting plane
ISO 8638 - Cardiovascular implants and EN ISO 8638 -
extracorporeal systems - Extracorporeal
blood circuit for haemodialysers,
haemodiafilters and haemofilters
---------------------- Page: 6 ----------------------
SIST EN 60601-2-16:2015
EN 60601-2-16:2015 (E)
Annex ZZ
(informative)
Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the

European Commission and the European Free Trade Association, and within its scope the

Standard covers all relevant essential requirements given in Annex I of EU Directive 93/42/EEC of

14 June 1993 concerning medical devices.

Compliance with this standard provides one means of conformity with the specified essential

requirements of the Directive concerned.

WARNING: Other requirements and other EU Directives can be applied to the products falling

within the scope of this standard.
---------------------- Page: 7 ----------------------
SIST EN 60601-2-16:2015
---------------------- Page: 8 ----------------------
SIST EN 60601-2-16:2015
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
CODE PRIX
ICS 11.040.20;11.040.25 ISBN 978-2-8322-0042-1

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 9 ----------------------
SIST EN 60601-2-16:2015
– 2 – 60601-2-16 © IEC:2012
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

---------------------- Page: 10 ----------------------
SIST EN 60601-2-16:2015
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

all national electrotechnical committees (IEC National Committees). The object of IEC is to promote

international co-operation on all questions concerning standardization in the electrical and electronic fields. To

this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,

Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC

Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested

in the subject dealt with may participate in this preparatory work. International, governmental and non-

governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely

with the International Organization for Standardization (ISO) in accordance with conditions determined by

agreement between the two organizations.

2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international

consensus of opinion on the relevant subjects since each technical committee has representation from all

interested IEC National Committees.

3) IEC Publications have the form of recommendations for international use and are accepted by IEC National

Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC

Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any

misinterpretation by any end user.

4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications

transparently to the maximum extent possible in their national and regional publications. Any divergence

between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in

the latter.

5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity

assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any

services carried out by independent certification bodies.

6) All users should ensure that they have the latest edition of this publication.

7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and

members of its technical committees and IEC National Committees for any personal injury, property damage or

other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and

expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC

Publications.

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 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.
---------------------- Page: 11 ----------------------
SIST EN 60601-2-16:2015
– 4 – 60601-2-16 © IEC:2012
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.
---------------------- Page: 12 ----------------------
SIST EN 60601-2-16:2015
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

understanding of its contents. Users should therefore print this document using a

colour printer.
---------------------- Page: 13 ----------------------
SIST EN 60601-2-16:2015
– 6 – 60601-2-16 © IEC:2012
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.
---------------------- Page: 14 ----------------------
SIST EN 60601-2-16:2015
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
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.

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

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.
___________

The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for

basic safety and essential performance.
---------------------- Page: 15 ----------------------
SIST EN 60601-2-16:2015
– 8 – 60601-2-16 © IEC:2012
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.
---------------------- Page: 16 ----------------------
SIST EN 60601-2-16:2015
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 med
...

SLOVENSKI STANDARD
SIST EN 60601-2-16:2015
01-september-2015
1DGRPHãþD
SIST EN 60601-2-16:1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLRSUHPH]DNHPRGLDOL]RNHPRGLDILOWUDFLMRLQNHPRILOWUDFLMR

Medical electrical equipment - Part 2-16: Particular requirements for basic safety and

essential performance of haemodialysis, haemodiafiltration and haemofiltration
equipment

Medizinische elektrische Geräte - Teil 2-16: Besondere Festlegungen für die Sicherheit

einschließlich der wesentlichen Leistungsmerkmale von Hämodialyse-,
Hämodiafiltrations- und Hämofiltrationsgeräten

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
Ta slovenski standard je istoveten z: EN 60601-2-16:2015
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN 60601-2-16:2015 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
EUROPEAN STANDARD EN 60601-2-16
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2015
ICS 11.040.20; 11.040.25 Supersedes EN 60601-2-16:1998
English Version
Medical electrical equipment - Part 2-16: Particular requirements
for the basic safety and essential performance of haemodialysis,
haemodiafiltration and haemofiltration equipment
(IEC 60601-2-16:2012)

Appareils électromédicaux - Partie 2-16: Exigences Medizinische elektrische Geräte - Teil 2-16: Besondere

particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der

essentielles des appareils d'hémodialyse, wesentlichen Leistungsmerkmale von Hämodialyse-,

d'hémodiafiltration et d'hémofiltration Hämodiafiltrations- und Hämofiltrationsgeräten

(IEC 60601-2-16:2012) (IEC 60601-2-16:2012)

This European Standard was approved by CENELEC on 2015-04-14. CENELEC members are bound to comply with the CEN/CENELEC

Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC

Management Centre or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation

under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the

same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,

Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,

Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.

Ref. No. EN 60601-2-16:2015 E
---------------------- Page: 2 ----------------------
EN 60601-2-16:2015 (E)
Foreword

The text of document 62D/972/FDIS, future edition 4 of IEC 60601-2-16, prepared by SC 62D,

"Electromedical equipment", of IEC TC 62, "Electrical equipment in medical practice" was submitted

to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-16:2015.
The following dates are fixed:
• latest date by which the document has (dop) 2016-01-14
to be implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2018-04-14
• latest date by which the national
standards conflicting with the
document have to be withdrawn
This document supersedes EN 60601-2-16:1998.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such

patent rights.
This document has been prepared under a mandate given to CENELEC by the European

Commission and the European Free Trade Association, and supports essential requirements of EU

Directive(s).

For the relationship with EU Directive see informative Annex ZZ, which is an integral part of this

document.
Endorsement notice

The text of the International Standard IEC 60601-2-16:2012 was approved by CENELEC as a

European Standard without any modification.

In the official version, for Bibliography, the following notes have to be added for the standards

indicated:
IEC 60601-2-16:1998 NOTE Harmonized as EN 60601-2-16:1998 (not modified).
IEC 60601-2-39 NOTE Harmonized as EN 60601-2-39.
ISO 11197 NOTE Harmonized as EN ISO 11197.
---------------------- Page: 3 ----------------------
EN 60601-2-16:2015 (E)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following documents, in whole or in part, are normatively referenced in this document and are

indispensable for its application. For dated references, only the edition cited applies. For undated

references, the latest edition of the referenced document (including any amendments) applies.

NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant

EN/HD applies.

NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:

www.cenelec.eu.
Annex ZA of EN 60601-1:2006 applies with the following exceptions:
Publication Year Title EN/HD Year
Replacement :
IEC 60601-1-2 2007 Medical electrical equipment - Part 1-2: EN 60601-1-2 2007
General requirements for basic safety and
essential performance - Collateral
+ corr March 2010
standard: Electromagnetic compatibility -
Requirements and tests
IEC 60601-1-6 2010 Medical electrical equipment - Part 1-6: EN 60601-1-6 2010
General requirements for basic safety and
essential performance - Collateral
standard: Usability
IEC 60601-1-8 2006 Medical electrical equipment - Part 1-8: EN 60601-1-8 2007
General requirements for basic safety and
essential performance - Collateral
+ corr March 2010
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: EN 60601-1-10 2008
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: EN 60601-1-11 2010
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 EN 62366 2008
engineering to medical devices
---------------------- Page: 4 ----------------------
EN 60601-2-16:2015 (E)
ISO 594-2 - Conical fittings with 6 % (Luer) taper for
syringes, needles and certain other
medical equipment - Part 2: Lock fittings
ISO 3744 - Acoustics - Determination of sound power EN ISO 3744 -
levels and sound energy levels of noise
sources using sound pressure -
Engineering methods for an essentially
free field over a reflecting plane
ISO 8638 - Cardiovascular implants and EN ISO 8638 -
extracorporeal systems - Extracorporeal
blood circuit for haemodialysers,
haemodiafilters and haemofilters
---------------------- Page: 5 ----------------------
EN 60601-2-16:2015 (E)
Annex ZZ
(informative)
Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the

European Commission and the European Free Trade Association, and within its scope the

Standard covers all relevant essential requirements given in Annex I of EU Directive 93/42/EEC of

14 June 1993 concerning medical devices.

Compliance with this standard provides one means of conformity with the specified essential

requirements of the Directive concerned.

WARNING: Other requirements and other EU Directives can be applied to the products falling

within the scope of this standard.
---------------------- Page: 6 ----------------------
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
CODE PRIX
ICS 11.040.20;11.040.25 ISBN 978-2-8322-0042-1

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 7 ----------------------
– 2 – 60601-2-16 © IEC:2012
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

---------------------- Page: 8 ----------------------
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

all national electrotechnical committees (IEC National Committees). The object of IEC is to promote

international co-operation on all questions concerning standardization in the electrical and electronic fields. To

this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,

Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC

Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested

in the subject dealt with may participate in this preparatory work. International, governmental and non-

governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely

with the International Organization for Standardization (ISO) in accordance with conditions determined by

agreement between the two organizations.

2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international

consensus of opinion on the relevant subjects since each technical committee has representation from all

interested IEC National Committees.

3) IEC Publications have the form of recommendations for international use and are accepted by IEC National

Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC

Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any

misinterpretation by any end user.

4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications

transparently to the maximum extent possible in their national and regional publications. Any divergence

between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in

the latter.

5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity

assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any

services carried out by independent certification bodies.

6) All users should ensure that they have the latest edition of this publication.

7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and

members of its technical committees and IEC National Committees for any personal injury, property damage or

other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and

expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC

Publications.

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 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.
---------------------- Page: 9 ----------------------
– 4 – 60601-2-16 © IEC:2012
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.
---------------------- Page: 10 ----------------------
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

understanding of its contents. Users should therefore print this document using a

colour printer.
---------------------- Page: 11 ----------------------
– 6 – 60601-2-16 © IEC:2012
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.
---------------------- Page: 12 ----------------------
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
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.

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

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.
___________

The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for

basic safety and essential performance.
---------------------- Page: 13 ----------------------
– 8 – 60601-2-16 © IEC:2012
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.
---------------------- Page: 14 ----------------------
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 imp
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