IEC 60601-2-16:2008
(Main)Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
IEC 60601-2-16:2008 applies to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. IEC 60601-2-16:2008 does not take into consideration the dialysing fluid control system of Haemodialysis equipment using regeneration of dialysing 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 60601-2-16:2008 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 60601-2-16:2008 includes all medical electrical equipment that is intended to deliver a haemodialysis, haemodiafiltration and haemofiltration treatment to a patient suffering from kidney failure. This third edition cancels and replaces the second edition of IEC 60601-2-16, published in 1998. This edition constitutes a technical revision. Changes since the previous edition include, among others, a summary of additional essential performance requirements, revision of terms and definitions, classification of applied parts and limits as numbers for protection against hazardous outputs, in the annex. The contents of the corrigendum of October 2008 have been included in this copy.
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 60601-2-16:2008 s'applique à la sécurité de base et aux performances essentielles des appareils d'hémodialyse, d'hémodiafiltration et d'hémofiltration, désignés ci-après sous le terme d'appareils d'hémodialyse. La CEI 60601-2-16:2008 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 celle du patient. La CEI 60601-2-16:2008 spécifie les exigences minimales de sécurité relatives aux appareils d'hémodialyse. Ces appareils sont destinés àêtre 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 CEI 60601-2-16:2008 s'applique à tout appareil em destiné à fournir un traitement d'hémodialyse, d'hémodiafiltration et d'hémofiltration à un patient souffrant d'insuffisance rénale. Cette troisième édition annule et remplace la deuxième édition de la CEI 60601-2-16 publiée en 1998. La présente édition constitue une révision technique. Les évolutions par rapport à l'édition précédente comprennent, entre autres, un résumé des exigences supplémentaires relatives aux performances essentielles, la révision des termes et des définitions, la classification des parties appliquées et des limites chiffrées relatives à la protection contre les caractéristiques de sortie dangereuses, en Annexe. Le contenu du corrigendum d'octobre 2008 a été pris en considération dans cet exemplaire.
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IEC 60601-2-16
Edition 3.0 2008-04
INTERNATIONAL
STANDARD
Medical electrical equipment –
Part 2-16: Particular requirements for basic safety and essential performance of
haemodialysis, haemodiafiltration and haemofiltration equipment
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
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International Standards for all electrical, electronic and related technologies.
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IEC 60601-2-16
Edition 3.0 2008-04
INTERNATIONAL
STANDARD
Medical electrical equipment –
Part 2-16: Particular requirements for basic safety and essential performance of
haemodialysis, haemodiafiltration and haemofiltration equipment
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
XA
ICS 11.040.20 ISBN 2-8318-9720-3
– 2 – 60601-2-16 © IEC:2008(E)
CONTENTS
FOREWORD.3
INTRODUCTION.6
201.1 Scope, object and related standards .7
201.2 Normative references.9
201.3 Terms and definitions.9
201.4 General requirements.12
201.5 General requirements for testing of ME EQUIPMENT.15
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .15
201.7 ME EQUIPMENT identification, marking and documents.15
201.8 Protection against electrical HAZARDS from ME EQUIPMENT.19
201.9 Protection against mechanical hazards of me equipment and me systems .21
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 .31
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
203 General requirements for radiation protection in diagnostic X-ray equipment.33
206 Usability.33
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems.33
209 Requirements for the reduction of environmental impacts.34
210 Process requirements for the development of physiologic closed-loop
controllers .34
Annexes .35
Annex AA (informative) Particular guidance and rationale.36
Bibliography.52
Index of defined terms used in this particular standard.53
Figure 201.101 – Continuous air infusion test set-up .28
Figure AA.1 – Example of the HAEMODIALYSIS ME SYSTEM.50
Table 201.101 – ESSENTIAL PERFORMANCE requirements .12
60601-2-16 © IEC:2008(E) – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-16: Particular requirements for 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 provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
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 third edition cancels and replaces the second edition of IEC 60601-2-16, published in
1998. This edition constitutes a technical revision. Changes since the previous edition
include, among others, a summary of additional essential performance requirements, revision
of terms and definitions, classification of applied parts and limits as numbers for protection
against hazardous outputs, in the annex.
– 4 – 60601-2-16 © IEC:2008(E)
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/671/FDIS 62D/681/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.
60601-2-16 © IEC:2008(E) – 5 –
The committee has decided that the contents of this particular standard will remain
unchanged until the maintenance result 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.
A bilingual version of this publication may be issued at a later date.
The contents of the corrigendum of October 2008 have been included in this copy.
– 6 – 60601-2-16 © IEC:2008(E)
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.
60601-2-16 © IEC:2008(E) – 7 –
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-16: Particular requirements for basic safety and
essential performance of haemodialysis, haemodiafiltration
and haemofiltration equipment
201.1 Scope, object and related standards
Clause 1 of IEC 60601-1:2005 applies, except as follows:
201.1.1 Scope
Addition:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as
HAEMODIALYSIS EQUIPMENT.
This International standard does not take into consideration the DIALYSING FLUID control
...
IEC 60601-2-16 ®
Edition 3.0 2008-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-16: Particular requirements for 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
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by
any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either IEC or
IEC's member National Committee in the country of the requester.
If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication,
please contact the address below or your local IEC member National Committee for further information.
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
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et les microfilms, sans l'accord écrit de la CEI ou du Comité national de la CEI du pays du demandeur.
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publication, utilisez les coordonnées ci-après ou contactez le Comité national de la CEI de votre pays de résidence.
IEC Central Office
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CH-1211 Geneva 20
Switzerland
Email: inmail@iec.ch
Web: www.iec.ch
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.
Catalogue of IEC publications: www.iec.ch/searchpub
The IEC on-line Catalogue enables you to search by a variety of criteria (reference number, text, technical committee,…).
It also gives information on projects, withdrawn and replaced publications.
IEC Just Published: www.iec.ch/online_news/justpub
Stay up to date on all new IEC publications. Just Published details twice a month all new publications released. Available
on-line and also by email.
Electropedia: www.electropedia.org
The world's leading online dictionary of electronic and electrical terms containing more than 20 000 terms and definitions
in English and French, with equivalent terms in additional languages. Also known as the International Electrotechnical
Vocabulary online.
Customer Service Centre: www.iec.ch/webstore/custserv
If you wish to give us your feedback on this publication or need further assistance, please visit the Customer Service
Centre FAQ or contact us:
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IEC 60601-2-16 ®
Edition 3.0 2008-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-16: Particular requirements for 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 XA
ICS 11.040.20 ISBN 978-2-88912-333-9
– 2 – 60601-2-16 IEC:2008
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions . 9
201.4 General requirements . 12
201.5 General requirements for testing of ME EQUIPMENT . 15
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 15
201.7 ME EQUIPMENT identification, marking and documents. 15
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 19
201.9 Protection against mechanical hazards of me equipment and me systems . 21
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 . 31
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
203 General requirements for radiation protection in diagnostic X-ray equipment . 33
206 Usability . 33
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems . 33
209 Requirements for the reduction of environmental impacts. 34
210 Process requirements for the development of physiologic closed-loop
controllers . 34
Annexes . 35
Annex AA (informative) Particular guidance and rationale . 36
Bibliography . 52
Index of defined terms used in this particular standard. 53
Figure 201.101 – Continuous air infusion test set-up . 28
Figure AA.1 – Example of the HAEMODIALYSIS ME SYSTEM . 50
Table 201.101 – ESSENTIAL PERFORMANCE requirements . 12
60601-2-16 IEC:2008 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-16: Particular requirements for 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 third edition cancels and replaces the second edition of IEC 60601-2-16, published in
1998. This edition constitutes a technical revision. Changes since the previous edition
include, among others, a summary of additional essential performance requirements, revision
of terms and definitions, classification of applied parts and limits as numbers for protection
against hazardous outputs, in the annex.
– 4 – 60601-2-16 IEC:2008
This bilingual version, published in 2011-02, corresponds to the English version.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/671/FDIS 62D/681/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.
The French version of this standard has not been voted upon.
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
...
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