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IEC 60601-2-16-ed.6.0
Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
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STANDARD published on 6.1.2025
The information about the standard:
Designation standards: IEC 60601-2-16-ed.6.0
Publication date standards: 6.1.2025
SKU: NS-1210138
The number of pages: 208
Approximate weight : 655 g (1.44 lbs)
Country: International technical standard
Category: Technical standards IEC
The category - similar standards:
Transfusion, infusion and injection equipmentSyringes, needles and catheters
Annotation of standard text IEC 60601-2-16-ed.6.0 :
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. LIEC 60601-2-40:2025 sapplique a la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des ELECTROMYOGRAPHES et des APPAREILS A POTENTIEL EVOQUE, designes ci-apres sous le terme APPAREILS EM. Si un article ou un paragraphe est specifiquement destine a etre 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 a la fois aux APPAREILS EM et aux SYSTEMES EM, selon le cas. Les APPAREILS EM suivants sont exclus de la liste: • APPAREILS EM destines a une application therapeutique; • APPAREILS EM destines a etre utilises avec les neurostimulateurs electriques transcutanes et les stimulateurs musculaires electriques (APPAREILS EM couverts par lIEC 60601-2-10). LIEC 60601-2-40:2024 annule et remplace la deuxieme edition parue en 2016. Cette edition constitue une revision technique. Cette edition inclut les modifications techniques majeures suivantes par rapport a ledition precedente: a) des exigences relatives aux stimulateurs a tension constante ont ete ajoutees; b) des exigences relatives aux STIMULATEURS VISUELS ont ete clarifiees. LIEC 60601-2-16:2024 sapplique a la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS DHEMODIALYSE, dHEMODIAFILTRATION et dHEMOFILTRATION, designes ci-apres sous le terme dAPPAREILS DHEMODIALYSE. Elle sapplique aux APPAREILS DHEMODIALYSE destines a etre utilises soit par le personnel medical, soit sous la surveillance dexperts medicaux, y compris les APPAREILS DHEMODIALYSE mis en fonctionnement par le PATIENT, que les APPAREILS DHEMODIALYSE soient utilises dans un hopital ou dans un environnement domestique. Si un article ou un paragraphe est specifiquement destine a etre applicable uniquement aux APPAREILS EM, ou uniquement aux SYSTEMES EM, le titre et le contenu de cet article ou de ce paragraphe lindiquent. Si cela nest pas le cas, larticle ou le paragraphe sapplique a la fois aux APPAREILS EM et aux SYSTEMES EM, selon le cas. Le present document ne prend pas en consideration les informations specifiques de securite du systeme de controle du LIQUIDE DE DIALYSE de lAPPAREIL DHEMODIALYSE qui utilise la regeneration du LIQUIDE DE DIALYSE ou des SYSTEMES DE TRANSMISSION CENTRALISES pour le LIQUIDE DE DIALYSE. Il prend cependant en consideration les exigences specifiques de securite de ces APPAREILS DHEMODIALYSE relatives a la securite electrique et la securite du PAT
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