IEC 60601-2-16:2025
(Main)Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
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.
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 23500-4),
– sacs pour LIQUIDE DE DIALYSE préproduits,
– systèmes d'alimentation en EAU DE DIALYSE (voir l'ISO 23500-2),
– SYSTEMES DE TRANSMISSION CENTRALISES pour les CONCENTRES DE LIQUIDE DE DIALYSE (voir l'ISO 23500-4), décrits comme systèmes de mélange de concentré en vrac dans un centre de dialyse,
– appareils de DIALYSE PERITONEALE (voir l'IEC 60601-2-39).
L'IEC 60601-2-16:2024 annule et remplace la cinquième édition parue en 2018. Cette édition constitue une révision technique.
Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente:
a) m
General Information
Relations
Buy Standard
Standards Content (Sample)
IEC 60601-2-16 ®
Edition 6.0 2025-01
REDLINE VERSION
INTERNATIONAL
STANDARD
Medical electrical equipment –
Part 2-16: Particular requirements for the 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
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.
IEC Secretariat Tel.: +41 22 919 02 11
3, rue de Varembé info@iec.ch
CH-1211 Geneva 20 www.iec.ch
Switzerland
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 corrigendum or an amendment might have been published.
IEC publications search - webstore.iec.ch/advsearchform IEC Products & Services Portal - products.iec.ch
The advanced search enables to find IEC publications by a Discover our powerful search engine and read freely all the
variety of criteria (reference number, text, technical publications previews, graphical symbols and the glossary.
committee, …). It also gives information on projects, replaced With a subscription you will always have access to up to date
and withdrawn publications. content tailored to your needs.
IEC Just Published - webstore.iec.ch/justpublished
Electropedia - www.electropedia.org
Stay up to date on all new IEC publications. Just Published
The world's leading online dictionary on electrotechnology,
details all new publications released. Available online and once
containing more than 22 500 terminological entries in English
a month by email.
and French, with equivalent terms in 25 additional languages.
Also known as the International Electrotechnical Vocabulary
IEC Customer Service Centre - webstore.iec.ch/csc
(IEV) online.
If you wish to give us your feedback on this publication or need
further assistance, please contact the Customer Service
Centre: sales@iec.ch.
IEC 60601-2-16 ®
Edition 6.0 2025-01
REDLINE VERSION
INTERNATIONAL
STANDARD
Medical electrical equipment –
Part 2-16: Particular requirements for the basic safety and essential performance
of haemodialysis, haemodiafiltration and haemofiltration equipment
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.20; 11.040.25 ISBN 978-2-8327-0127-0
– 2 – IEC 60601-2-16:2025 RLV © IEC 2025
CONTENTS
FOREWORD . 4
INTRODUCTION . 2
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 . 19
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 19
201.7 ME EQUIPMENT identification, marking and documents . 19
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 . 41
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 42
201.15 Construction of ME EQUIPMENT . 44
201.16 * ME SYSTEMS . 45
201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 46
202 Electromagnetic disturbances – Requirements and tests . 46
208 General requirements, tests and guidance for ALARM SYSTEMS in MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS . 46
209 Requirements for environmentally conscious design . 49
210 Requirements for the development of PHYSIOLOGIC CLOSED-LOOP
CONTROLLERS . 49
211 * Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL
SYSTEMS used in the HOME HEALTHCARE ENVIRONMENT . 49
Annexes . 50
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures . 51
Annex AA (informative) Particular guidance and rationale . 52
Annex BB (informative) Examples of HAZARDS, foreseeable sequences of events, and
HAZARDOUS SITUATIONS in HAEMODIALYSIS EQUIPMENT . 81
Annex CC (informative) Example of an open alarm interface specification . 94
Bibliography . 98
Index of defined terms used in this document . 101
Figure 201.101 – Continuous Air infusion test setup with example dimensions . 37
Figure AA.1 – Powered by SUPPLY MAINS only . 63
Figure AA.2 – Alarm at depletion of battery for limited functionality . 63
Figure AA.3 – Alarm before battery for limited functionality gets depleted
(30 min maximum) . 64
Figure AA.4 – Alarm before battery for limited functionality gets depleted (battery
lasting for equal or less than 30 min) . 64
Figure AA.5 – Alarm at battery depletion . 65
Figure AA.6 – Alarm before battery gets depleted (30 min maximum) . 65
Figure AA.7 – DIALYSIS FLUID composition test cases for determining the ALARM SIGNAL
activation . 67
Figure AA.8 – Example of a HAEMODIALYSIS ME SYSTEM . 76
Figure CC.1 – Simplified circuit diagram . 95
ESSENTIAL PERFORMANCE requirements . 15
Table 201.101 –
Table AA.1 – Example of ALARM CONDITION priorities according to 6.1.2 of
IEC 60601‑1‑8:2006, IEC 60601‑1‑8:2006/AMD1:2012 and
IEC 60601‑1‑8:2006/AMD2:2020, adapted for HAEMODIALYSIS EQUIPMENT needs . 79
Table BB.1 – Example of HAZARDOUS SITUATIONS list following ISO 14971:20072019,
Annex EC . 82
Table CC.1 – Periodic functional check of the INPUT INTERFACE . 96
Table CC.2 – Reaction of HAEMODIALYSIS EQUIPMENT . 96
Table CC.3 – Signal result of signal input to INTERNAL SIGNAL PROCESSING unit . 96
Table CC.4 – Reaction of HAEMODIALYSIS EQUIPMENT during the treatment . 97
– 4 – IEC 60601-2-16:2025 RLV © IEC 2025
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) IEC draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). IEC takes no position concerning the evidence, validity or applicability of any claimed patent rights in
respect thereof. As of the date of publication of this document, IEC had not received notice of (a) patent(s), which
may be required to implement this document. However, implementers are cautioned that this may not represent
the latest information, which may be obtained from the patent database available at https://patents.iec.ch. IEC
shall not be held responsible for identifying any or all such patent rights.
This redline version of the official IEC Standard allows the user to identify the changes
made to the previous edition IEC 60601-2-16:2018. A vertical bar appears in the margin
wherever a change has been made. Additions are in green text, deletions are in
strikethrough red text.
IEC 60601-2-16 has been prepared by subcommittee 62D: Particular medical equipment,
software, and systems, of IEC technical committee 62: Medical equipment, software, and
systems. It is an International Standard.
This sixth edition 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
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.