Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 60601-2-16:2018)

IEC 60601-2-16:2018 applies to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. IEC 60601-2-16:2018 does not take into consideration the dialysis fluid control system of Haemodialysis equipment using regeneration of dialysis fluid and central delivery systems. It does however take into consideration the specific safety requirements of such haemodialysis equipment concerning electrical safety and patient safety. IEC 60601-2-16:2018 specifies the minimum safety requirements for haemodialysis equipment. These devices are intended for use either by medical staff or for use by the patient or other trained personnel under the supervision of medical expertise. IEC 60601-2-16:2018 includes all electromedical equipment that is intended to deliver a haemodialysis, haemodiafiltration and haemofiltration treatment to a patient suffering from kidney failure. This fifth edition cancels and replaces the fourth edition of IEC 60601-2-16, published in 2012. This edition includes the following significant technical changes with respect to the previous edition: a) update of references to IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, of references and requirements to IEC 60601-1-2:2014, of references to IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013, of references and requirements to IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012, of references to IEC 60601-1-9:2007 and IEC 60601-1-9:2007/AMD1:2013, of references to IEC 60601-1-10:2007 and IEC 60601-1-10:2007/AMD1:2013 and of references to IEC 60601-1-11:2015; b) widening of the scope; c) editorial improvements; d) addition of requirements for anticoagulant delivery means; e) other few small technical changes.

Medizinische elektrische Geräte - Teil 2-16: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Hämodialyse-, Hämodiafiltrations- und Hämofiltrationsgeräten (IEC 60601-2-16:2018)

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 60601-2-16:2018)

NEW!IEC 60601-2-16:2018 est disponible sous forme de IEC 60601-2-16:2018 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.L'IEC 60601-2-16:2018 s'applique à la sécurité de base et aux performances essentielles des appareils d'hémodialyse, d'hémodiafiltration et d'hémofiltration. L'IEC 60601-2-16:2018 ne prend pas en compte le système de contrôle du liquide de dialyse de l'appareil d'hémodialyse utilisant la régénération du liquide de dialyse et les systèmes de transmission centralisés. Toutefois, elle prend en compte les exigences de sécurité spécifiques de l'appareil d'hémodialyse concernant la sécurité électrique et la sécurité du patient. L'IEC 60601-2-16:2018 spécifie les exigences minimales de sécurité relatives aux appareils d'hémodialyse. Ces appareils sont destinés à être utilisés soit par le personnel médical, soit par le patient, soit par d'autres personnes formées, sous le contrôle d'un personnel ayant une bonne compétence médicale. La présente Norme internationale s'applique à tout appareil electromédical destiné à fournir un traitement d'hémodialyse, d'hémodiafiltration et d'hémofiltration à un patient souffrant d'insuffisance rénale. Cette cinquième édition annule et remplace la quatrième édition de l'IEC 60601-2-16 parue en 2012. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente: a) actualisation des références à l'IEC 60601-1:2005 et l'IEC 60601-1:2005/AMD1:2012, des références et des exigences à l'IEC 60601-1-2:2014, des références à l'IEC 60601-1-6:2010 et l'IEC 60601-1-6:2010/AMD1:2013, des références et des exigences à l'IEC 60601-1-8:2006 et l'IEC 60601-1-8:2006/AMD1:2012, des références à l'IEC 60601-1-9:2007 et l'IEC 60601-1-9:2007/AMD1:2013, des références à l'IEC 60601-1-10:2007 et l'IEC 60601-1-10:2007/AMD1:2013 ainsi que des références à l'IEC 60601-1-11:2015; b) élargissement du domaine d'application; c) améliorations d'ordre rédactionnel; d) ajout d'exigences concernant les dispositifs de transmission d'anticoagulant; e) quelques autres modifications techniques limitées.

Medicinska električna oprema - 2-16. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za hemodializo, hemodiafiltracijo in hemofiltracijo (IEC 60601-2-16:2018)

Standard IEC 60601-2-16:2018 se uporablja za osnovno varnost in bistvene lastnosti opreme za hemodializo, hemodiafiltracijo in hemofiltracijo. Standard IEC 60601-2-16:2018 ne zajema nadzornega sistema za dializno tekočino opreme za hemodializo, ki uporablja regeneracijo dializne tekočine in osrednje sisteme dovajanja. Zajema pa specifične varnostne zahteve opreme za hemodializo v povezavi z električno varnostjo in varnostjo pacienta. Standard IEC 60601-2-16:2018 navaja minimalne varnostne zahteve opreme za hemodializo. Te naprave so namenjene uporabi s strani zdravniškega osebja oziroma pacienta ali drugega usposobljenega osebja pod nadzorom oseb s strokovnim medicinskim znanjem. Standard IEC 60601-2-16:2018 vključuje elektromedicinsko opremo za hemodializo, hemodiafiltracijo in hemofiltracijo, namenjeno pacientom z odpovedjo ledvic. Peta izdaja razveljavlja in nadomešča četrto izdajo standarda IEC 60601-2-16, objavljeno leta 2012. Ta izdaja vključuje naslednje pomembne tehnične spremembe glede na prejšnjo izdajo: a) posodobitev sklicev na standarda IEC 60601-1:2005 in IEC 60601-1:2005/AMD1:2012, sklicev na standard IEC 60601-1-2:2014 in njegovih zahtev, sklicev na standarda IEC 60601-1-6:2010 in IEC 60601-1-6:2010/AMD1:2013, sklicev na standarda IEC 60601-1-8:2006 in IEC 60601-1-8:2006/AMD1:2012 ter njunih zahtev, sklicev na standarda IEC 60601-1-9:2007 in IEC 60601-1-9:2007/AMD1:2013, sklicev na standarda IEC 60601-1-10:2007 in IEC 60601-1-10:2007/AMD1:2013 ter sklicev na standard IEC 60601-1-11:2015; b) razširitev področja uporabe; c) redakcijske izboljšave; d) dodane zahteve za sredstva za dovajanje antikoagulantov; e) drugih nekaj manjših tehničnih sprememb.

General Information

Status
Published
Publication Date
11-Aug-2019
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
30-May-2019
Due Date
04-Aug-2019
Completion Date
12-Aug-2019

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SLOVENSKI STANDARD
SIST EN IEC 60601-2-16:2019
01-september-2019
Nadomešča:
SIST EN 60601-2-16:2015
Medicinska električna oprema - 2-16. del: Posebne zahteve za osnovno varnost in

bistvene lastnosti opreme za hemodializo, hemodiafiltracijo in hemofiltracijo (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 (IEC 60601-2-16:2018)

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

einschließlich der wesentlichen Leistungsmerkmale von Hämodialyse-,
Hämodiafiltrations- und Hämofiltrationsgeräten (IEC 60601-2-16:2018)

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 60601-2-16:2018)
Ta slovenski standard je istoveten z: EN IEC 60601-2-16:2019
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN IEC 60601-2-16:2019 en

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

---------------------- Page: 1 ----------------------
SIST EN IEC 60601-2-16:2019
---------------------- Page: 2 ----------------------
SIST EN IEC 60601-2-16:2019
EUROPEAN STANDARD EN IEC 60601-2-16
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2019
ICS 11.040.20; 11.040.25 Supersedes EN 60601-2-16:2015
English Version
Medical electrical equipment - Part 2-16: Particular requirements
for the basic safety and essential performance of haemodialysis,
haemodiafiltration and haemofiltration equipment
(IEC 60601-2-16:2018)

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 60601-2-16:2018) (IEC 60601-2-16:2018)

This European Standard was approved by CENELEC on 2018-05-25. 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, Serbia, 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: Rue de la Science 23, B-1040 Brussels

© 2019 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.

Ref. No. EN IEC 60601-2-16:2019 E
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SIST EN IEC 60601-2-16:2019
EN IEC 60601-2-16:2019 (E)
European foreword

The text of document 62D/1557/FDIS, future edition 5 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 IEC 60601-2-16:2019.
The following dates are fixed:

• latest date by which the document has to be implemented at national (dop) 2019-11-24

level by publication of an identical national standard or by endorsement

• latest date by which the national standards conflicting with the (dow) 2022-05-24

document have to be withdrawn
This document supersedes EN 60601-2-16:2015.

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

patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.

Endorsement notice

The text of the International Standard IEC 60601-2-16:2018 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 60601-2-24 NOTE Harmonized as EN 60601-2-24
IEC 60601-2-39 NOTE Harmonized as EN 60601-2-39
IEC 80001-1:2010 NOTE Harmonized as EN 80001-1:2011 (not modified)
ISO 8637-2 NOTE Harmonized as EN ISO 8637-2
ISO 11197 NOTE Harmonized as EN ISO 11197
ISO 23500-1 NOTE Harmonized as EN ISO 23500-1
ISO 23500-2 NOTE Harmonized as EN ISO 23500-2
ISO 23500-3 NOTE Harmonized as EN ISO 23500-3
ISO 23500-4 NOTE Harmonized as EN ISO 23500-4
ISO 23500-5 NOTE Harmonized as EN ISO 23500-5
ISO 14971:2007 NOTE Harmonized as EN ISO 14971:2012 (not modified)
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SIST EN IEC 60601-2-16:2019
EN IEC 60601-2-16:2019 (E)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

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

applies.

NOTE 1 Where 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, except as follows:
Publication Year Title EN/HD Year
Replacement
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
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: EN 60601-1-6 2010
General requirements for basic safety and
essential performance - Collateral
standard: Usability
+ A1 2013 + A1 2015
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
Standard: General requirements, tests and
guidance for alarm systems in medical
electrical equipment and medical electrical
systems
- - + corrigendum Mar. 2010
+ A1 2012 + A1 2013
- - + AC 2014
- - + A11 2017
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
+ A1 2013 + A1 2015
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SIST EN IEC 60601-2-16:2019
EN IEC 60601-2-16:2019 (E)

IEC 60601-1-11 2015 Medical electrical equipment - Part 1-11: EN 60601-1-11 2015

General requirements for basic safety and
essential performance - Collateral
Standard: Requirements for medical
electrical equipment and medical electrical
systems used in the home healthcare
environment
IEC 61672-1 - Electroacoustics - Sound level meters - EN 61672-1 -
Part 1: Specifications
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
---------------------- Page: 6 ----------------------
SIST EN IEC 60601-2-16:2019
IEC 60601-2-16
Edition 5.0 2018-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –

Part 2-16: Particular requirements for the basic safety and essential performance

of haemodialysis, haemodiafiltration and haemofiltration equipment
Appareils électromédicaux –

Partie 2-16: Exigences particulières pour la sécurité de base et les performances

essentielles des appareils d'hémodialyse, d'hémodiafiltration et d'hémofiltration

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.20; 11.040.25 ISBN 978-2-8322-5549-0

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 ----------------------
SIST EN IEC 60601-2-16:2019
– 2 – IEC 60601-2-16:2018 © IEC 2018
CONTENTS

FOREWORD ........................................................................................................................... 4

INTRODUCTION ..................................................................................................................... 7

201.1 Scope, object and related standards ..................................................................... 8

201.2 Normative references ......................................................................................... 10

201.3 Terms and definitions ......................................................................................... 11

201.4 General requirements ......................................................................................... 14

201.5 General requirements for testing ME EQUIPMENT .................................................. 17

201.6 Classification of ME EQUIPMENT and ME SYSTEMS ................................................. 17

201.7 ME EQUIPMENT identification, marking and documents ......................................... 17

201.8 Protection against electrical HAZARDS from ME EQUIPMENT ................................... 22

201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS ......... 23

201.10 Protection against unwanted and excessive radiation HAZARDS ........................... 23

201.11 Protection against excessive temperatures and other HAZARDS ........................... 23

201.12 * Accuracy of controls and instruments and protection against hazardous

outputs ............................................................................................................... 24

201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT ............................. 34

201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) ........................................... 34

201.15 Construction of ME EQUIPMENT ............................................................................. 35

201.16 * ME SYSTEMS ..................................................................................................... 35

201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS .................... 36

202 Electromagnetic disturbances – Requirements and tests .................................... 36

208 General requirements, tests and guidance for ALARM SYSTEMS in MEDICAL

ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS .................................... 37

209 Requirements for environmentally conscious design ........................................... 39

210 Requirements for the development of PHYSIOLOGIC CLOSED-LOOP

CONTROLLERS ...................................................................................................... 39

211 * Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL

SYSTEMS used in the HOME HEALTHCARE ENVIRONMENT .......................................... 39

Annexes ............................................................................................................................... 41

Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic

mixtures ................................................................................................................................ 42

Annex AA (informative) Particular guidance and rationale .................................................... 43

Annex BB (informative) Examples of HAZARDS, foreseeable sequences of events, and

HAZARDOUS SITUATIONS in HAEMODIALYSIS EQUIPMENT ............................................................. 62

Bibliography .......................................................................................................................... 71

Index of defined terms used in this particular standard.......................................................... 74

Figure 201.101 – Continuous air infusion test setup with example dimensions ...................... 30

Figure AA.1 – Example of a HAEMODIALYSIS ME SYSTEM ......................................................... 58

Table 201.101 – ESSENTIAL PERFORMANCE requirements ........................................................ 14

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SIST EN IEC 60601-2-16:2019
IEC 60601-2-16:2018 © IEC 2018 – 3 –
Table AA.1 – Example of ALARM CONDITION priorities according to 6.1.2
of IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012, adapted for

HAEMODIALYSIS EQUIPMENT needs ........................................................................................... 60

Table BB.1 – HAZARDOUS SITUATION list following ISO 14971:2007, Annex E ......................... 62

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SIST EN IEC 60601-2-16:2019
– 4 – IEC 60601-2-16:2018 © IEC 2018
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-16: Particular requirements for the basic safety and
essential performance of haemodialysis, haemodiafiltration
and haemofiltration equipment
FOREWORD

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 fifth edition cancels and replaces the fourth edition of IEC 60601-2-16 published in 2012.

This edition constitutes a technical revision.

This edition includes the following significant technical changes with respect to the previous

edition:
a) update of references to IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, of

references and requirements to IEC 60601-1-2:2014, of references to IEC 60601-1-6:2010

and IEC 60601-1-6:2010/AMD1:2013, of references and requirements to
IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012, of references to
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SIST EN IEC 60601-2-16:2019
IEC 60601-2-16:2018 © IEC 2018 – 5 –
IEC 60601-1-9:2007 and IEC 60601-1-9:2007/AMD1:2013, of references to
IEC 60601-1-10:2007 and IEC 60601-1-10:2007/AMD1:2013 and of references to
IEC 60601-1-11:2015;
b) widening of the scope;
c) editorial improvements;
d) addition of requirements for anticoagulant delivery means;
e) other few small technical changes.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/1557/FDIS 62D/1585/RVD

Full information on the voting for the approval of this particular standard can be found in the

report on voting indicated in the above table.

This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

In this document, the following print types are used:
– requirements and definitions: roman type;
– test specifications: italic type;

– informative material appearing outside of tables, such as notes, examples and references: in smaller type.

Normative text of tables is also in a smaller type;

– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS

NOTED: SMALL CAPITALS.
In referring to the structure of this document, the term

– "clause" means one of the seventeen numbered divisions within the table of contents,

inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);

– "subclause" means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all

subclauses of Clause 7).

References to clauses within this document are preceded by the term "Clause" followed by

the clause number. References to subclauses within this particular standard are by number

only.

In this document, the conjunctive "or" is used as an "inclusive or" so a statement is true if any

combination of the conditions is true.

The verbal forms used in this document conform to usage described in Clause 7 of the

ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb:

– "shall" means that compliance with a requirement or a test is mandatory for compliance

with this document;

– "should" means that compliance with a requirement or a test is recommended but is not

mandatory for compliance with this document;

– "may" is used to describe a permissible way to achieve compliance with a requirement or

test.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title

indicates that there is guidance or rationale related to that item in Annex AA.
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SIST EN IEC 60601-2-16:2019
– 6 – IEC 60601-2-16:2018 © IEC 2018

A list of all parts of the IEC 60601 series, published under the general title Medical electrical

equipment, can be found on the IEC website.

The committee has decided that the contents of this publication will remain unchanged until

the stability date indicated on the IEC website under "http://webstore.iec.ch" in the data

related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates

that it contains colours which are considered to be useful for the correct

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

colour printer.

NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing

organizations may need a transitional period following publication of a new, amended or revised IEC publication in

which to make products in accordance with the new requirements and to equip themselves for conducting new or

revised tests. It is the recommendation of the committees that the content of this publication be adopted for

implementation nationally not earlier than 3 years from the date of publication.
---------------------- Page: 12 ----------------------
SIST EN IEC 60601-2-16:2019
IEC 60601-2-16:2018 © IEC 2018 – 7 –
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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SIST EN IEC 60601-2-16:2019
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MEDICAL ELECTRICAL EQUIPMENT –
Part 2-16: Particular requirements for the basic safety and
essential performance of haemodialysis, haemodiafiltration
and haemofiltration equipment
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of

HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as

HAEMODIALYSIS EQUIPMENT.

This document does not take into consideration specific safety details of the DIALYSIS FLUID

control system of HAEMODIALYSIS EQUIPMENT using regeneration of DIALYSIS FLUID or CENTRAL

DELIVERY SYSTEMS for DIALYSIS FLUID. It does, however, take into consideration the specific

HAEMODIALYSIS EQUIPMENT concerning electrical safety and
safety requirements of such
PATIENT safety.

This document specifies the minimum safety requirements for HAEMODIALYSIS EQUIPMENT.

These HAEMODIALYSIS EQUIPMENT are intended for use either by medical staff or for use by the

PATIENT or other trained personnel under medical supervision.

This document includes all ME EQUIPMENT that is intended to deliver a HAEMODIALYSIS,

HAEMODIAFILTRATION and HAEMOFILTRATION treatment to a PATIENT, independent of the

treatment duration and location.

If applicable, this document applies to the relevant parts of ME EQUIPMENT intended for other

extracorporeal blood purification treatments.
The particular requirements in this document do not apply to:
– EXTRACORPOREAL CIRCUITS (see ISO 8637-2, [12] );
– DIALYSERS (see ISO 8637-1, [11]);
– DIALYSIS FLUID CONCENTRATES (see ISO 23500-4, [18]);
– DIALYSIS WATER supply systems (see ISO 23500-2, [16]);

– CENTRAL DELIVERY SYSTEMS for DIALYSIS FLUID CONCENTRATES (see ISO 23500-4, [18]),

described as systems for bulk mixing concentrate at a dialysis facility;
– equipment used to perform PERITONEAL DIALYSIS (see IEC 60601-2-39, [8]).
___________

The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –

Part 1: General requirements for basic safety and essential performance.
Numbers in square brackets refer to the Bibliography.
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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 the general standard and Clause 201.2 of this particular standard.
IEC 60601-1-2:2014, IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012,

IEC 60601-1-10:2007 and IEC 60601-1-10:2007/AMD1:2013 and IEC 60601-1-11:2015 apply

as modified in Clauses 202, 208, 210 and 211. IEC 60601-1-3 and IEC 60601-1-12 do not

apply. IEC 60601-1-9:2007 and IEC 60601-1-9:2007/AMD1:2013 does not apply as noted in

Clause 209. All other published collateral standards in the IEC 60601-1 series apply as

published.
201.1.4 Particular standards
Replacement:

In the IEC 60601 series, particular standards may modify, replace or delete requirements

contained in the general standard and collateral standards as appropriate for the particular

ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.

For brevity, IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 are referred to in this

particular standard as the general standard. Collateral standards are referred to by their

document number.

The numbering of clauses and subclauses of this particular standard corresponds to that of

the general standard with the prefix "201" (e.g. 201.1 in this document addresses the content

of Clause 1 of the general standard) or applicable collateral standard with the prefix "20x"

where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this

particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral

standard, 203.4 in this particular standard addresses the content of Clause 4 of the

IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are

specified by the use of the following words:

"Replacement" means that the clause or subclause of the general standard or applicable

collateral standard is replaced completely by the text of this particular standard.

"Addition" means that the text of this particular standard is additional to the requirements of

the general standard or applicable collateral standard.

"Amendment" means that the clause or subclause of the general standard or applicable

collateral standard is amended as indicated by the text of this particular standard.

Subclauses, figures or tables which are additional to those of the general standard are

numbered starting from 201.101. However, due to the fact that definitions in the general

standard are numbered 3.1 through 3.147, additional definitions in this document are

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numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and

additional items aa), bb), etc.

Subclauses, figures or tables which are additional to those of a collateral standard are

numbered starting from 20x, where "x" is the number of the collateral standard, for example

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

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

collateral standards and this particular standard taken together.

Where there is no corresponding clause or subclause in this particular standard, the clause or

subclause of the general standard or applicable collateral standard, although possibly not

relevant, applies without modification; where it is intended that any part of the general

standard or applicable collateral standard, although possibly relevant, is not to be applied, a

statement to that effect is given in this particular standard.
201.2 Normative references
NOTE Informative references are listed in the bibliography.
Clause 2 of the general standard applies, except as follows:
Replacement:

IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic

safety and essential performance – Collateral Standard: Electromagnetic disturbances –

Requirements and tests
IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: Ge
...

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