EN IEC 60601-2-16:2025

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

IEC 60601-2-16:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as HAEMODIALYSIS EQUIPMENT. It applies to HAEMODIALYSIS EQUIPMENT intended for use either by medical staff or under the supervision of medical experts, including HAEMODIALYSIS EQUIPMENT operated by the PATIENT, regardless of whether the HAEMODIALYSIS EQUIPMENT is used in a hospital or domestic environment. 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. 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 safety requirements of such HAEMODIALYSIS EQUIPMENT concerning electrical safety and 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), – DIALYSERS (see ISO 8637-1 [2]), – DIALYSIS FLUID CONCENTRATES (see ISO 23500-4), – pre-manufactured DIALYSIS FLUID bags, – DIALYSIS WATER supply systems (see ISO 23500-2), – CENTRAL DELIVERY SYSTEMS for DIALYSIS FLUID CONCENTRATES (see ISO 23500-4), described as systems for bulk mixing concentrate at a dialysis facility, – equipment used to perform PERITONEAL DIALYSIS (see IEC 60601-2-39). IEC 60601-2-16:2024 cancels and replaces the fifth edition published in 2018. 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, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020, of references to IEC 60601‑1‑2:2014 and IEC 60601‑1‑2:2014/AMD1:2020, of references to IEC 60601‑1‑8:2006, IEC 60601‑1‑8:2006/AMD1:2012 and IEC 60601‑1‑8:2006/AMD2:2020, of references to IEC 60601‑1‑9:2007, IEC 60601‑1‑9:2007/AMD1:2013 and IEC 60601‑1‑9:2007/AMD2:2020, of references to IEC 60601‑1‑10:2007, IEC 60601‑1‑10:2007/AMD1:2013 and IEC 60601‑1‑10:2007/AMD2:2020 and of references to IEC 60601‑1‑11:2015 and IEC 60601‑1‑11:2015/AMD1:2020; b) consideration of ESSENTIAL PERFORMANCE in SINGLE FAULT CONDITION regarding IEC 60601‑1:2005/AMD1:2012/ISH1:2021; c) including the information given in the document 62D/1771A/INF regarding 201.11.8; d) including withdrawn IEC PAS 63023 as Annex CC; e) including SECURITY (CYBERSECURITY) requirements; f) consideration of HAEMODIALYSIS EQUIPMENT using pre-manufactured DIALYSIS FLUID bags; g) improvements for labelling; h) other minor technical improvements; i) editorial improvements.

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

L'IEC 60601-2-40:2025 s'applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des ELECTROMYOGRAPHES et des APPAREILS A POTENTIEL EVOQUE, désignés ci-après sous le terme APPAREILS EM. Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux APPAREILS EM, ou uniquement aux SYSTEMES EM, le titre et le contenu de cet article ou de ce paragraphe l’indiquent. Si cela n’est pas le cas, l’article ou le paragraphe s’applique à la fois aux APPAREILS EM et aux SYSTEMES EM, selon le cas. Les APPAREILS EM suivants sont exclus de la liste: • APPAREILS EM destinés à une application thérapeutique; • APPAREILS EM destinés à être utilisés avec les neurostimulateurs électriques transcutanés et les stimulateurs musculaires électriques (APPAREILS EM couverts par l'IEC 60601-2-10). L'IEC 60601-2-40:2024 annule et remplace la deuxième édition parue en 2016. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente: a) des exigences relatives aux stimulateurs à tension constante ont été ajoutées; b) des exigences relatives aux STIMULATEURS VISUELS ont été clarifiées. L'IEC 60601-2-16:2024 s'applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS D'HEMODIALYSE, d'HEMODIAFILTRATION et d'HEMOFILTRATION, désignés ci-après sous le terme d'APPAREILS D'HEMODIALYSE. Elle s'applique aux APPAREILS D'HEMODIALYSE destinés à être utilisés soit par le personnel médical, soit sous la surveillance d'experts médicaux, y compris les APPAREILS D'HEMODIALYSE mis en fonctionnement par le PATIENT, que les APPAREILS D'HEMODIALYSE soient utilisés dans un hôpital ou dans un environnement domestique. Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux APPAREILS EM, ou uniquement aux SYSTEMES EM, le titre et le contenu de cet article ou de ce paragraphe l'indiquent. Si cela n'est pas le cas, l'article ou le paragraphe s'applique à la fois aux APPAREILS EM et aux SYSTEMES EM, selon le cas. Le présent document ne prend pas en considération les informations spécifiques de sécurité du système de contrôle du LIQUIDE DE DIALYSE de l'APPAREIL D'HEMODIALYSE qui utilise la régénération du LIQUIDE DE DIALYSE ou des SYSTEMES DE TRANSMISSION CENTRALISES pour le LIQUIDE DE DIALYSE. Il prend cependant en considération les exigences spécifiques de sécurité de ces APPAREILS D'HEMODIALYSE relatives à la sécurité électrique et la sécurité du PATIENT. Le présent document spécifie les exigences minimales de sécurité relatives aux APPAREILS D'HEMODIALYSE. Ces APPAREILS D'HEMODIALYSE sont destinés à être utilisés soit par le personnel médical, soit par le PATIENT, soit par d'autres personnes formées, sous surveillance médicale. Le présent document s'applique à tous les APPAREILS EM destinés à fournir un traitement d'HEMODIALYSE, d'HEMODIAFILTRATION et d'HEMOFILTRATION à un PATIENT, indépendamment de la durée et du lieu de traitement. Le cas échéant, le présent document s'applique aux parties correspondantes des APPAREILS EM destinés à d'autres traitements extracorporels de purification du sang. Les exigences particulières du présent document ne s'appliquent pas aux: – CIRCUITS EXTRACORPORELS (voir l'ISO 8637-2), – DIALYSEURS (voir l'ISO 8637-1), – CONCENTRES DE LIQUIDE DE DIALYSE (voir l'ISO

Medicinska električna oprema - 2-16. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za hemodializo, hemodiafiltracijo in hemofiltracijo (IEC 60601-2-16:2025)

General Information

• Status: Published
• Publication Date: 20-Feb-2025
• 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: 21-Feb-2025
• Due Date: 21-Feb-2025
• Completion Date: 21-Feb-2025
• Ref Project: SIST EN IEC 60601-2-16:2025 - Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 60601-2-16:2025)

Relations

• Replaces: 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
• Effective Date: 21-Oct-2021

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2025
Medicinska električna oprema - 2-16. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za hemodializo, hemodiafiltracijo in hemofiltracijo (IEC
60601-2-16:2025)
Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and
essential performance of haemodialysis, haemodiafiltration and haemofiltration
equipment (IEC 60601-2-16:2025)
Medizinische elektrische Geräte - Teil 2-16: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Hämodialyse-,
Hämodiafiltrations- und Hämofiltrationsgeräten (IEC 60601-2-16:2025)
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 60601-2-16:2025)
Ta slovenski standard je istoveten z: EN IEC 60601-2-16:2025
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 February 2025
ICS 11.040.20; 11.040.25 Supersedes EN IEC 60601-2-16:2019
English Version
Medical electrical equipment - Part 2-16: Particular requirements
for the basic safety and essential performance of haemodialysis,
haemodiafiltration and haemofiltration equipment
(IEC 60601-2-16:2025)
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 60601-2-16:2025) (IEC 60601-2-16:2025)
This European Standard was approved by CENELEC on 2025-02-10. 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye 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
© 2025 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60601-2-16:2025 E

European foreword
The text of document 62D/2163/FDIS, future edition 6 of IEC 60601-2-16, prepared by SC 62D
"Particular medical equipment, software, and systems" of IEC/TC 62 "Medical equipment, software,
and systems" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2026-02-28
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2028-02-29
document have to be withdrawn
This document supersedes EN IEC 60601-2-16:2019 and all of its amendments and corrigenda (if
any).
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.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 60601-2-16:2025 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 standard indicated:
ISO 8637-2:2024 NOTE Approved as EN ISO 8637-2:2024 (not modified)
ISO 23500-4:2024 NOTE Approved as EN ISO 23500-4:2024 (not modified)
IEC 60601-2-39:2018 NOTE Approved as EN IEC 60601-2-39:2019 (not modified)
ISO 23500-1:2024 NOTE Approved as EN ISO 23500-1:2024 (not modified)
ISO 23500-5:2024 NOTE Approved as EN ISO 23500-5:2024 (not modified)
IEC 80001-1:2021 NOTE Approved as EN IEC 80001-1:2021 (not modified)
ISO 80369-1:2018 NOTE Approved as EN ISO 80369-1:2018 (not modified)
ISO 11197:2019 NOTE Approved as EN ISO 11197:2019 (not modified)
ISO 17664-1:2021 NOTE Approved as EN ISO 17664-1:2021 (not modified)
ISO 15883 series NOTE Approved as EN ISO 15883 series
IEC 60601-2-24:2012 NOTE Approved as EN 60601-2-24:2015 (not modified)
ISO 17664-2:2021 NOTE Approved as EN ISO 17664-2:2023 (not modified)
ISO 14971:2019 NOTE Approved as EN ISO 14971:2019 (not modified) +A11:2021
IEC 60601-1-9:2007 NOTE Approved as EN 60601-1-9:2008 (not modified)
IEC 60601-1-9:2007/A1:2013 NOTE Approved as EN 60601-1-9:2008/A1:2013 (not modified)
IEC 60601-1-9:2007/A2:2020 NOTE Approved as EN 60601-1-9:2008/A2:2020 (not modified)
IEC 62366-1:2015 NOTE Approved as EN 62366-1:2015 (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.cencenelec.eu.
Annex ZA of EN 60601-1:2006 , applies, except as follows:
Add:
Publication Year Title EN/HD Year
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- - + AC 2010
+ A1 2012 + A1 2013
- - + AC 2014
- - + A12 2014
+ A2 2020 + A2 2021
- - + AC 2022
- - + A13 2024
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
+ A2 2020 + A2 2021
As impacted by EN 60601-1:2006/AC:2010, EN 60601-1:2006/A1:2013, EN 60601-1:2006/A1:2013/AC:2014,
EN 60601-1:2006/A12:2014, EN 60601-1:2006/A2:2021, EN 60601-1:2006/AC:2022-12 and
EN 60601-1:2006/A13:2024.
Publication Year Title EN/HD Year
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
+ A1 2020 + A1 2021
IEC 61672-1 2013 Electroacoustics - Sound level meters - EN 61672-1 2013
Part 1: Specifications
ISO 3744 2010 Acoustics - Determination of sound power EN ISO 3744 2010
levels and sound energy levels of noise
sources using sound pressure -
Engineering methods for an essentially
free field over a reflecting plane
ISO 23500-3 2024 Preparation and quality management of EN ISO 23500-3 2024
fluids for haemodialysis and related
therapies – Part 3: Water for haemodialysis
and related therapies
IEC 60601-2-16 ®
Edition 6.0 2025-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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 978-2-8327-0088-4

– 2 – IEC 60601-2-16:2025 © IEC 2025
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 . 18
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 18
201.7 ME EQUIPMENT identification, marking and documents . 18
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 24
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 25
201.10 Protection against unwanted and excessive radiation HAZARDS . 25
201.11 Protection against excessive temperatures and other HAZARDS . 25
201.12 * Accuracy of controls and instruments and protection against hazardous
outputs . 28
201.13 Hazardous situations and fault conditions for ME EQUIPMENT . 39
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 39
201.15 Construction of ME EQUIPMENT . 41
201.16 * ME SYSTEMS . 42
201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 43
202 Electromagnetic disturbances – Requirements and tests . 43
208 General requirements, tests and guidance for ALARM SYSTEMS in MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS . 44
209 Requirements for environmentally conscious design . 46
210 Requirements for the development of PHYSIOLOGIC CLOSED-LOOP
CONTROLLERS . 46
211 * Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL
SYSTEMS used in the HOME HEALTHCARE ENVIRONMENT . 47
Annexes . 48
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures . 49
Annex AA (informative) Particular guidance and rationale . 50
Annex BB (informative) Examples of HAZARDS, foreseeable sequences of events, and
HAZARDOUS SITUATIONS in HAEMODIALYSIS EQUIPMENT . 79
Annex CC (informative) Example of an open alarm interface specification . 92
Bibliography . 96
Index of defined terms used in this document . 99

Figure 201.101 – Air infusion test setup with example dimensions . 35
Figure AA.1 – Powered by SUPPLY MAINS only . 61
Figure AA.2 – Alarm at depletion of battery for limit
...