EN 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.
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)
Ta del standarda IEC 60601 se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI OPREME ZA HEMODIALIZO, HEMODIAFILTRACIJO in HEMOFILTRACIJO (v nadaljevanju »OPREMA ZA HEMODIALIZO«). Uporablja se za OPREMO ZA HEMODIALIZO, ki jo uporablja zdravniško osebje ali se uporablja pod nadzorom oseb s strokovnim medicinskim znanjem, vključno z OPREMO ZA HEMODIALIZO, ki jo upravlja PACIENT, ne glede na to, ali se OPREMA ZA HEMODIALIZO uporablja v bolnišnici ali doma.
Če je točka ali podtočka namenjena samo obravnavi MEDICINSKE ELEKTRIČNE OPREME ali SISTEMOV, bo to zapisano v naslovu in vsebini točke ali podtočke. Če ni zapisano, točka ali podtočka obravnava MEDICINSKO ELEKTRIČNO OPREMO in SISTEME.
Ta dokument ne zajema specifičnih varnostnih podrobnosti nadzornega sistema za DIALIZNO RAZTOPINO OPREME ZA HEMODIALIZO, ki uporablja regeneracijo DIALIZNE RAZTOPINE ali OSREDNJE SISTEME DOVAJANJA DIALIZNE RAZTOPINE. Zajema pa specifične varnostne zahteve take OPREME ZA HEMODIALIZO v povezavi z električno varnostjo in varnostjo PACIENTA.
Ta dokument določa minimalne varnostne zahteve OPREME ZA HEMODIALIZO. Ta OPREMA ZA HEMODIALIZO je namenjena uporabi s strani zdravniškega osebja oziroma PACIENTA ali drugega usposobljenega osebja pod zdravniškim nadzorom.
Ta dokument vključuje vso MEDICINSKO ELEKTRIČNO OPREMO, ki je namenjena izvajanju HEMODIALIZE, HEMODIAFILTRACIJE in HEMOFILTRACIJE pri PACIENTU, ne glede na trajanje in lokacijo zdravljenja.
Če je primerno, se ta dokument uporablja za ustrezne dele MEDICINSKE ELEKTRIČNE OPREME, namenjene za druga zdravljenja z zunajtelesnim prečiščevanjem krvi.
Posebne zahteve v tem dokumentu se ne uporabljajo za:
– ZUNAJTELESNE PRETOČNE SISTEME (glej standard ISO 8637-2 [1]1);
– DIALIZATORJE (glej standard ISO 8637-1 [2]);
– KONCENTRATE DIALIZNE TEKOČINE (glej standard ISO 23500-4 [3]);
– predhodno izdelane vrečke za DIALIZNO TEKOČINO;
– sisteme za dovajanje DIALIZNE VODE (glej standard ISO 23500-2 [4]);
– CENTRALNE SISTEME DOVAJANJA KONCENTRATOV DIALIZNE TEKOČINE (glej standard ISO 23500-4 [3]), opisane kot sistemi za mešanje koncentrata v razsutem stanju v dializni opremi;
– opremo za PERITONEALNO DIALIZO (glej standard IEC 60601-2-39 [5]).
General Information
- Status
- Published
- Publication Date
- 20-Feb-2025
- 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
- 29-Dec-2023
- Completion Date
- 21-Feb-2025
Relations
- Effective Date
- 21-Oct-2021
Overview
EN IEC 60601-2-16:2025 (aligned with IEC 60601-2-16:2025) is the sixth-edition European/International standard specifying basic safety and essential performance requirements for haemodialysis, haemodiafiltration and haemofiltration equipment. It applies to medical electrical haemodialysis equipment intended for use by medical staff or under medical supervision - including patient-operated and home healthcare devices - across hospital and domestic environments. This edition cancels and replaces the 2018 (fifth) edition and constitutes a technical revision.
Key topics and technical requirements
The standard focuses on device safety, performance and risk-control measures specific to extracorporeal blood purification systems. Important technical topics include:
- Essential performance requirements and verification, including consideration of performance under single fault conditions.
- Electrical safety and patient protection for haemodialysis equipment and systems.
- Alarm systems: priorities, testing and guidance for alarm behaviour during treatment.
- Programmable Electrical Medical Systems (PEMS) and guidance for physiologic closed‑loop controllers.
- Electromagnetic compatibility (EMC) requirements and electromagnetic disturbance testing.
- Cybersecurity (security) requirements for haemodialysis equipment - newly included to address modern connected devices.
- Labelling and documentation improvements to support safe use and maintenance.
- Home healthcare considerations consistent with IEC 60601‑1‑11 for devices intended for domestic use.
- Normative tests and construction requirements, plus informative annexes with hazard examples, alarm interface specifications and guidance.
Note: the document excludes standalone extracorporeal circuits, dialysers, dialysis fluid concentrates and dialysis water supply systems (see ISO 8637‑1/2, ISO 23500 series) and peritoneal dialysis equipment (IEC 60601‑2‑39). The 2025 edition gives additional consideration to equipment that uses pre‑manufactured dialysis fluid bags while maintaining applicable exclusions for the bags themselves.
Practical applications - who uses this standard
This standard is essential for:
- Medical device manufacturers designing haemodialysis, haemodiafiltration and haemofiltration machines.
- Regulatory affairs and compliance teams preparing technical files and CE/UKCA/market submissions.
- Test laboratories and conformity assessment bodies performing safety, EMC and alarm tests.
- Clinical engineers, biomedical maintenance teams and hospital procurement specifying device requirements.
- Risk managers and design engineers implementing ISO 14971-based risk controls and cybersecurity measures.
Related standards
Key related documents referenced:
- IEC 60601‑1 series (general requirements for medical electrical equipment)
- IEC 60601‑1‑2 (EMC), IEC 60601‑1‑11 (home healthcare)
- ISO 8637‑1 / ISO 8637‑2 (dialysers and extracorporeal circuits)
- ISO 23500 series (dialysis fluid preparation and water)
- IEC 80001‑1 (IT network risk management)
- ISO 14971 (medical device risk management)
Keywords: haemodialysis equipment standard, IEC 60601‑2‑16:2025, medical electrical equipment, haemodiafiltration, haemofiltration, dialysis safety, medical device cybersecurity, essential performance, alarm systems, EMC.
Frequently Asked Questions
EN IEC 60601-2-16:2025 is a standard published by CLC. Its full title is "Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment". This standard covers: 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.
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.
EN IEC 60601-2-16:2025 is classified under the following ICS (International Classification for Standards) categories: 11.040.20 - Transfusion, infusion and injection equipment; 11.040.25 - Syringes, needles an catheters. The ICS classification helps identify the subject area and facilitates finding related standards.
EN IEC 60601-2-16:2025 has the following relationships with other standards: It is inter standard links to EN IEC 60601-2-16:2019. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
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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 limited functionality . 61
Figure AA.3 – Alarm before battery for limited functionality gets depleted
(30 min maximum) . 62
IEC 60601-2-16:2025 © IEC 2025 – 3 –
Figure AA.4 – Alarm before battery for limited functionality gets depleted (battery
lasting for equal or less than 30 min) . 62
Figure AA.5 – Alarm at battery depletion . 63
Figure AA.6 – Alarm before battery gets depleted (30 min maximum) . 63
Figure AA.7 – DIALYSIS FLUID composition test cases for determining the ALARM SIGNAL
activation . 65
Figure AA.8 – Example of a HAEMODIALYSIS ME SYSTEM . 74
Figure CC.1 – Simplified circuit diagram . 93
ESSENTIAL PERFORMANCE requirements . 14
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 . 77
Table BB.1 – Example of HAZARDOUS SITUATIONS list following ISO 14971:2019,
Annex C . 80
Table CC.1 – Periodic functional check of the INPUT INTERFACE . 94
Table CC.2 – Reaction of HAEMODIALYSIS EQUIPMENT . 94
Table CC.3 – Signal result of signal input to INTERNAL SIGNAL PROCESSING unit . 94
Table CC.4 – Reaction of HAEMODIALYSIS EQUIPMENT during the treatment . 95
– 4 – IEC 60601-2-16:2025 © 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.
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.
IEC 60601-2-16:2025 © IEC 2025 – 5 –
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[17] 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.
The text of this International Standard is based on the following documents:
Draft Report on voting
62D/2163/FDIS 62D/2184/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this International Standard is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/publications.
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 IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 AND
IEC 60601-1:2005/AMD2:2020, IN THIS DOCUMENT 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 document are by number only.
– 6 – IEC 60601-2-16:2025 © IEC 2025
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.
A list of all parts of the IEC 60601 and IEC 80601 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 document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
• reconfirmed,
• withdrawn, or
• revised.
NOTE The attention of the 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.
IMPORTANT – The "colour inside" logo on the cover page of this document 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.
IEC 60601-2-16:2025 © IEC 2025 – 7 –
INTRODUCTION
The minimum safety requirements specified in this document are considered to provide for a
practical degree of safety in the operation of HAEMODIALYSIS, HAEMODIAFILTRATION and
HAEMOFILTRATION EQUIPMENT.
– 8 – IEC 60601-2-16:2025 © IEC 2025
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 IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/
AMD2:2020 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. 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
for DIALYSIS FLUID. It does, however, take into consideration the specific
DELIVERY SYSTEMS
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 [1] ),
– DIALYSERS (see ISO 8637-1 [2]),
– DIALYSIS FLUID CONCENTRATES (see ISO 23500-4 [3]),
– pre-manufactured DIALYSIS FLUID bags,
– DIALYSIS WATER supply systems (see ISO 23500-2 [4]),
___________
Numbers in square brackets refer to the Bibliography.
IEC 60601-2-16:2025 © IEC 2025 – 9 –
– CENTRAL DELIVERY SYSTEMS for DIALYSIS FLUID CONCENTRATES (see ISO 23500-4 [3]),
described as systems for bulk mixing concentrate at a dialysis facility,
– equipment used to perform PERITONEAL DIALYSIS (see IEC 60601-2-39 [5]).
201.1.2 Object
Replacement:
The object of this document is to establish BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for HAEMODIALYSIS EQUIPMENT.
201.1.3 Collateral standards
Addition:
This document refers to those applicable collateral standards that are listed in Clause 2 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and
Clause 201.2 of this document.
IEC 60601‑1‑2:2014 and IEC 60601‑1‑2:2014/AMD1:2020, IEC 60601‑1‑8:2006,
IEC 60601‑1‑8:2006/AMD1:2012 and IEC 60601‑1‑8:2006/AMD2:2020, IEC 60601‑1‑10:2007,
IEC 60601‑1‑10:2007/AMD1:2013 and IEC 60601‑1‑10:2007/AMD2:2020,
IEC 60601‑1‑11:2015 and IEC 60601‑1‑11:2015/AMD1:2020 apply as modified in Clauses 202,
208, 210 and 211.
IEC 60601‑1‑3 does not apply. IEC 60601‑1‑9:2007, IEC 60601‑1‑9:2007/AMD1:2013 and
IEC 60601‑1‑9:2007/AMD2:2020 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 IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/
AMD2:2020 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 IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
The numbering of clauses and subclauses of this document corresponds to that of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 with the
prefix "201" (e.g. 201.1 in this document addresses the content of Clause 1 of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020) 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 document addresses the content of Clause 4 of
the IEC 60601-1-2 collateral standard, 203.4 in this document addresses the content of
Clause 4 of the IEC 60601-1-3 collateral standard, etc.). The changes to the text of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are
specified by the use of the following words:
"Replacement" means that the clause or subclause of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or applicable collateral
standard is replaced completely by the text of this document.
– 10 – IEC 60601-2-16:2025 © IEC 2025
"Addition" means that the text of this document is additional to the requirements of
IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or
applicable collateral standard.
"Amendment" means that the clause or subclause of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or applicable collateral
standard is amended as indicated by the text of this document.
Subclauses, figures or tables which are additional to those of IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are numbered starting from
201.101. However, due to the fact that definitions in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 are numbered 3.1 through
3.154, additional definitions in this document are 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 IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, any applicable collateral
standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this document, the clause or subclause
of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 or
applicable collateral standard, although possibly not relevant, applies without modification;
where it is intended that any part of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and
IEC 60601-1:2005/AMD2:2020 or applicable collateral standard, although possibly relevant, is
not to be applied, a statement to that effect is given in this document.
201.2 Normative references
NOTE Informative references are listed in the Bibliography.
Clause 2 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/
AMD2:2020 applies, except as follows:
Addition:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
IEC 60601-1-10:2007, Medical electrical equipment – Part 1-10: General requirements for basic
safety and essential performance – Collateral Standard: Requirements for the development of
physiologic closed-loop controllers
IEC 60601-1-10:2007/AMD1:2013
IEC 60601-1-10:2007/AMD2:2020
IEC 60601-1-11:2015, Medical electrical equipment – Part 1-11: 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 60601-1-11:2015/AMD1:2020
IEC 61672-1:2013, Electroacoustics – Sound level meters – Part 1: Specifications
IEC 60601-2-16:2025 © IEC 2025 – 11 –
ISO 3744:2010, Acoustics – Determination of sound power 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 fluids for haemodialysis and related
therapies – Part 3: Water for haemodialysis and related therapies
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, IEC 60601-1-2:2014 and
IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012 and
IEC 60601-1-8:2006/AMD2:2020, IEC 60601-1-10:2007, IEC 60601-1-10:2007/AMD1:2013
and IEC 60601-1-10:2007/AMD2:2020, IEC 60601-1-11:2015 and IEC 60601-1-11:2015/
AMD1:2020, and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following
addresses:
• IEC Electropedia: available at https://www.electropedia.org/
• ISO Online browsing platform: available at https://www.iso.org/obp
NOTE Refer to section "Index of defined terms used in this particular standard" for the index of defined terms.
201.3.8
* APPLIED PART
Replacement:
EXTRACORPOREAL CIRCUIT and all parts permanently and conductively connected to it (e.g.
DIALYSIS FLUID circuit)
Note 1 to entry: See Figure AA.8 in Informative Annex AA Subclause 201.16 and see 201.16.6.3.
Note 2 to entry: One example of an APPLIED PART is the EXTRACORPOREAL CIRCUIT including any pre-manufactured
DIALYSIS FLUID bags, extension lines, and drain bags in a stand-alone system connected during treatment.
Note 3 to entry: Another example of an APPLIED PART is the EXTRACORPOREAL CIRCUIT including connected DIALYSIS
FLUID bags, that are online prepared before treatment without the patient connected and drain bags. During treatment
the online preparation part of the HAEMODIALYSIS EQUIPMENT is conductively disconnected.
Note 4 to entry: Another example of an APPLIED PART is the EXTRACORPOREAL CIRCUIT including all connected fluid
paths of the HAEMODIALYSIS EQUIPMENT and the connection to a drain during the treatment.
201.3.78
PATIENT CONNECTION
Addition:
Note 1 to entry: The PATIENT blood lines connectors are the individual points on the APPLIED PART through which a
current can flow between the PATIENT and the HAEMODIALYSIS EQUIPMENT in NORMAL CONDITION or SINGLE FAULT
CONDITION.
Additional terms and definitions:
201.3.201
ARTERIAL PRESSURE
pressure measured in the blood withdrawal line of the EXTRACORPOREAL CIRCUIT between the
PATIENT CONNECTION and DIALYSER connection
Note 1 to entry: A difference can be made between the pre-pump pressure, which is upstream of the blood pump,
and post-pump pressure, which is downstream of the blood pump.
– 12 – IEC 60601-2-16:2025 © IEC 2025
201.3.202
* BLOOD LEAK
leakage of blood from the blood compartment to the DIALYSIS FLUID compartment of the DIALYSER
Note 1 to entry: When performing an HF PROCESS, this involves the filtration fluid section.
201.3.203
CENTRAL DELIVERY SYSTEM
part of a ME SYSTEM which proportions DIALYSIS FLUID CONCENTRATE and DIALYSIS WATER for
distribution as DIALYSIS FLUID to the HAEMODIALYSIS EQUIPMENT or distributes DIALYSIS FLUID
CONCENTRATE
201.3.204
DIALYSER
device containing a semi-permeable membrane that is used to perform HD, HDF or HF
201.3.205
DIALYSIS FLUID
DIALYSATE
DIALYSIS SOLUTION
DIALYSING FLUID
aqueous fluid containing electrolytes and, usually, buffer and glucose, which is intended to
exchange solutes with blood during HAEMODIALYSIS
Note 1 to entry: The DIALYSIS FLUID could be pre-manufactured in bags as pharmaceuticals according to the relevant
pharmacopoeia monograph or be prepared by the HAEMODIALYSIS EQUIPMENT or be influenced in composition by the
HAEMODIALYSIS EQUIPMENT.
[SOURCE: ISO 23500-1:2024 [6], 3.15, modified – The notes have been deleted and a new
Note 1 to entry was added.]
201.3.206
DIALYSIS FLUID CONCENTRATE
substances which, when appropriately diluted or dissolved with DIALYSIS WATER, produce the
DIALYSIS FLUID
201.3.207
DIALYSIS WATER
water that has been treated to meet the requirements of ISO 23500-3:2024 and which is suitable
for use in HAEMODIALYSIS applications, including the preparation of DIALYSIS FLUID, reprocessing
of DIALYSERS, preparation of DIALYSIS FLUID CONCENTRATE and preparation of SUBSTITUTION FLUID
for online convective therapies
Note 1 to entry: The words "water for dialysis", "permeate" and "reverse osmosis water" are commonly used as
synonyms of DIALYSIS WATER.
[SOURCE: ISO 23500-1:2024 [6], 3.17, modified – The note was reworded.]
201.3.208
EXTRACORPOREAL CIRCUIT
blood lines, DIALYSER and any integral ACCESSORY
Note 1 to entry: An alternative for DIALYSER could be a HF-filter, adsorber or other device.
201.3.209
HAEMODIAFILTRATION
HDF
PROCESS whereby concentrations of water-soluble substances in a PATIENT'S blood and an
excess of fluid of a PATIENT are corrected by a simultaneous combination of HD and HF
IEC 60601-2-16:2025 © IEC 2025 – 13 –
201.3.210
HAEMODIALYSIS
HD
PROCESS whereby concentrations of water-soluble substances in a PATIENT'S blood and an
excess of fluid of a PATIENT are corrected by bidirectional diffusive transport and
ULTRAFILTRATION across a semi-permeable membrane separating the blood from the DIALYSIS
FLUID
Note 1 to entry: This PROCESS typically includes fluid removal by filtration. This PROCESS is usually also
accompanied by diffusion of substances from the DIALYSIS FLUID into the blood.
201.3.211
* HAEMODIALYSIS EQUIPMENT
ME EQUIPMENT or ME SYSTEM used to perform at least one of the following: HAEMODIALYSIS,
HAEMODIAFILTRATION, HAEMOFILTRATION
Note 1 to entry: When the term ME EQUIPMENT is used in headings, it is equivalent to HAEMODIALYSIS EQUIPMENT.
When the term ME EQUIPMENT is used in the text, it is referring to a general ME EQUIPMENT.
201.3.212
HAEMOFILTRATION
HF
PROCESS whereby concentrations of water-soluble substances in a PATIENT'S blood and an
excess of fluid of a PATIENT are corrected by convective transport via ULTRAFILTRATION and
partial replacement by a SUBSTITUTION FLUID resulting in the required NET FLUID REMOVAL
201.3.213
NET FLUID REMOVAL
fluid loss from the PATIENT
Note 1 to entry: Historically, this term was "weight loss".
201.3.214
* ONLINE HDF
HAEMODIAFILTRATION PROCEDURE where the HAEMODIALYSIS EQUIPMENT produces SUBSTITUTION
FLUID for infusion from DIALYSIS FLUID for the HAEMODIAFILTRATION treatment
201.3.215
ONLINE HF
*
HAEMOFILTRATION PROCEDURE where the HAEMODIALYSIS EQUIPMENT produces the SUBSTITUTION
FLUID for infusion from DIALYSIS FLUID for the HAEMOFILTRATION treatment
201.3.216
* PROTECTIVE SYSTEM
automatic system, or a constructional feature, specifically designed to protect the PATIENT
HAZARDOUS SITUATIONS
against
201.3.217
SUBSTITUTION FLUID
fluid used in HF and HDF treatments which is directly infused into the EXTRACORPOREAL CIRCUIT
as a replacement for the fluid that is removed from the blood by filtration
[SOURCE: ISO 23500-1:2024 [6], 3.42, modified – The words "patient's blood" and
"ultrafiltration" have been replaced respectively by "EXTRACORPOREAL CIRCUIT" and "filtration" in
the definition, and the note has been deleted.]
– 14 – IEC 60601-2-16:2025 © IEC 2025
201.3.218
TRANSMEMBRANE PRESSURE
TMP
fluid pressure difference exerted across the semi-permeable membrane of the DIALYSER
Note 1 to entry: Generally, the mean TMP is used. In practice, the displayed TRANSMEMBRANE PRESSURE is usually
estimated from the measured EXTRACORPOREAL CIRCUIT pressure minus the measured DIALYSIS FLUID pressure, each
obtained at a single point.
201.3.219
* ULTRAFILTRATION
PROCESS of fluid removal from the PATIENT'S blood across the semi-permeable membrane of the
DIALYSER
201.3.220
VENOUS PRESSURE
pressure measured in the blood return line of the EXTRACORPOREAL CIRCUIT between the
DIALYSER connection and PATIENT CONNECTION
201.4 General requirements
Clause 4 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/
AMD2:2020 applies, except as follows:
201.4.3 * Essential performance
Additional subclauses:
201.4.3.101 * Additional ESSENTIAL PERFORMANCE requirements
If applicable, the ESSENTIAL PERFORMANCE of HAEMODIALYSIS EQUIPMENT includes, but is not
limited to, the functions found in the subclauses listed in Table 201.101, which shall be met
within the tolerances specified by the MANUFACTURER under NORMAL CONDITION.
HAEMODIALYSIS EQUIPMENT for ESSENTIAL PERFORMANCE in SINGLE FAULT
The behaviour of the
CONDITION shall be determined by the MANUFACTURER'S RISK MANAGEMENT.
Table 201.101 – ESSENTIAL PERFORMANCE requirements
Requirement Subclause
Blood flow rate 201.4
...
EN IEC 60601-2-16:2025の標準は、血液透析、血液透析濾過、および血液濾過に用いる医療機器の基本的な安全性と必須性能に関する特定要件を規定しています。この文書は、医療スタッフによる使用や医療専門家の監督の下での使用を意図した血液透析機器に適用され、患者自身が操作する機器にも適用されます。つまり、病院や家庭環境を問わず幅広い場所での使用をサポートします。 この標準の強みは、医療機器の安全性に関する厳格な基準を設けている点です。特に、血液透析機器に求められる最低限の安全要件を明確に定義しており、患者や医療従事者の安全を優先しています。また、特定の安全詳細についても考慮がなされており、特に電気的な安全性や患者の安全に焦点を当てた要求が盛り込まれています。 加えて、IEC 60601-2-16:2025は、技術的な更新が行われており、過去の版からの重要な改訂が含まれています。これには、最新の相互参照の更新や単一障害条件における必須性能に関する考慮が含まれ、実際の使用シナリオに基づいて安全性が保証されています。サイバーセキュリティに関する要件も取り入れられており、現代の医療機器にとって重要な側面が考慮されています。 このように、EN IEC 60601-2-16:2025は、医療分野における血液透析機器の安全性と性能を確保するための強力な標準であり、その適用範囲や要求は非常に現実的で relevant です。特に、患者の安全を第一に考えた設計が求められる現代医療において、この標準の重要性はますます高まっています。
EN IEC 60601-2-16:2025 표준은 혈액투석, 혈액여과 및 혈액여과학 장비에 대한 기본 안전성과 필수 성능 요구 사항을 정의합니다. 이 표준은 의료진이나 의료 전문가의 감독하에 또는 환자가 직접 사용할 수 있는 혈액투석 장비에 적용되며, 병원이나 가정 환경 모두에서 사용할 수 있습니다. 즉, 다양한 사용 환경과 이용자를 고려하여 포괄적인 안전성을 제공하는 것이 큰 강점입니다. 이 표준은 혈액투석 장비의 최소 안전 요구 사항을 명시하고 있으며, 환자 안전 및 전기적 안전에 대한 특정 요구 사항을 고려합니다. 특히, 이 기준은 의료용 전기 기기와 시스템에 적용되며, 혈액투석과 관련된 여러 치료 방식에 맞춰 매우 유용합니다. 또한, 해당 표준은 불필요한 혼돈을 방지하기 위해 특정 조항이 의료 장비나 의료 시스템에만 적용되는 경우 그 내용을 명확히 기재하고 있습니다. 2024년에 발행된 최신 개정판은 이전 판에 비해 여러 기술적 변경 사항을 포함하고 있어 더욱 신뢰성을 높이고 있습니다. 특히, 단일 결함 조건에서 필수 성능을 고려하는 점과 사이버 보안 요구 사항을 포함한 점은 현대 기술 환경에서 매우 중요한 요소입니다. 이러한 다양한 개선 사항들은 혈액투석 장비의 안전성과 성능을 더욱 보장하며, 최종 사용자인 환자의 안전을 중시하는 방향으로 발전하고 있습니다. 따라서 EN IEC 60601-2-16:2025는 의료 분야에서 필수적으로 참고해야 할 표준으로, 그 범위와 강점이 명확히 드러나 있습니다. 혈액투석 장비에 관한 표준으로서 그 유용성과 관련성이 매우 높으며, 이를 통해 안전한 의료 환경 구축에 기여할 수 있습니다.
The EN IEC 60601-2-16:2025 standard is a crucial document outlining the basic safety and essential performance requirements for haemodialysis, haemodiafiltration, and haemofiltration equipment. Its comprehensive scope includes all types of haemodialysis equipment-whether used by medical personnel or operated by patients under supervision-thus ensuring their safe application across various settings, including hospitals and home environments. One of the strengths of this standard is its detailed emphasis on distinguishing between medical equipment (ME EQUIPMENT) and medical systems (ME SYSTEMS), clearly defining the applicability of clauses pertinent to each. This clarity is pivotal for manufacturers and healthcare providers, ensuring that safety and performance criteria are consistently met. The standard also prioritizes patient safety by specifying minimum safety requirements focused particularly on electrical safety, which is critical in preventing malfunctions that could jeopardize patient health. Another notable strength is the document’s adaptability to evolving healthcare needs, as evidenced by its recent technical revisions. Among the significant updates, the standard now includes references to contemporary cybersecurity requirements, ensuring a holistic approach to safety that encompasses digital threats. Additional improvements in labelling and the inclusion of essential performance considerations in single fault conditions reflect a proactive stance toward enhancing the usability and safety of haemodialysis equipment. Furthermore, the incorporation of modern manufacturing practices, such as the use of pre-manufactured dialysis fluid bags, demonstrates the standard’s relevance in contemporary medical practice. By addressing both established protocols and new methodologies, it serves as a critical framework that encourages ongoing advancements in patient care and medical technology. Overall, the EN IEC 60601-2-16:2025 standard is not only comprehensive in its scope but also robust in its application. It lays a solid foundation for ensuring that haemodialysis equipment is both safe and effective, catering to the needs of patients and healthcare providers alike while addressing the complexities introduced by modern technologies. This relevance and thoroughness make it indispensable for stakeholders in the medical field.
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