EN IEC 60601-2-16:2019

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

NEW!IEC 60601-2-16:2018 is available as IEC 60601-2-16:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.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

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

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: 23-May-2019
• Withdrawal Date: 23-May-2022
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 24-May-2019
• Completion Date: 24-May-2019
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN IEC 60601-2-16:2019 - 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)

Relations

• Replaces: EN 60601-2-16:2015 - Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
• Effective Date: 23-Aug-2016
• Revised: FprEN IEC 60601-2-16:2024 - Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
• Effective Date: 21-Oct-2021

Standards Content (Sample)

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

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

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)

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
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

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

– 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

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

– 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
...