IEC 60601-2-39-ed.4.0

Podrobné informace

Označení: IEC 60601-2-39-ed.4.0

Datum vydání: 11.12.2024

Stran: 112

Země: Mezinárodní technická norma

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Anotace

IEC 60601-2-39:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PERITONEAL DIALYSIS ME EQUIPMENT, hereafter referred to as PD EQUIPMENT. It applies to PD EQUIPMENT intended for use either by medical staff or under the supervision of medical experts, including PD EQUIPMENT operated by the PATIENT, regardless of whether the PD 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 DIALYSING SOLUTION control system of PD EQUIPMENT using regeneration of DIALYSING SOLUTION or CENTRAL DELIVERY SYSTEMS for DIALYSING SOLUTION. It does, however, take into consideration the specific safety requirements of such PD EQUIPMENT concerning electrical safety and PATIENT safety. This document specifies the minimum safety requirements for PD EQUIPMENT. These PD 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 PERITONEAL DIALYSIS treatment to a PATIENT, independent of the treatment duration and location. These particular requirements do not apply to: – PRE-MANUFACTURED DIALYSING SOLUTION bags, – DIALYSING SOLUTION CIRCUITS, – DIALYSING SOLUTION CONCENTRATE, – DIALYSIS WATER supply systems (see ISO 23500-2) , – CENTRAL DELIVERY SYSTEMS for DIALYSING SOLUTION CONCENTRATES, described as systems for bulk mixing concentrate at a dialysis facility, – equipment used to perform HAEMODIALYSIS (see IEC 60601-2-16). IEC 60601-2-39:2024 cancels and replaces the third 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 the information given in the document 62D/1734/INF regarding technical issues of the previous edition; e) including SECURITY (CYBERSECURITY) requirements; f) additions related to online PD SOLUTION generation (ONLINE PD); g) improvements regarding the definition of the APPLIED PART; h) improvement of the essential performance requirements clause/subclauses; i) improvements for labelling; j) other minor technical improvements; k) editorial improvements. LIEC 60601-2-39:2024 s’applique a la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS EM DE DIALYSE PERITONEALE, designes ci-apres sous le terme d’APPAREILS DP. Elle s’applique aux APPAREILS DP destines a etre utilises soit par le personnel medical soit sous la surveillance d’experts medicaux, y compris les APPAREILS DP mis en fonctionnement par le PATIENT, que les APPAREILS DP 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 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. Le present document ne prend pas en consideration les informations specifiques de securite du systeme de controle de la SOLUTION DE DIALYSE des APPAREILS DP qui utilise la regeneration de la SOLUTION DE DIALYSE ou des SYSTEMES DE TRANSMISSION CENTRALISES pour la SOLUTION DE DIALYSE. Il prend cependant en consideration les exigences specifiques de securite de ces APPAREILS DP relatives a la securite electrique et la securite du PATIENT. Le present document specifie les exigences minimales de securite des APPAREILS DP. Les APPAREILS DP sont destines a etre utilises par le personnel medical ou le PATIENT ou tout personnel forme et sous surveillance medicale. Le present document s’applique a tous les APPAREILS EM destines a fournir un traitement par DIALYSE PERITONEALE au PATIENT, independamment de la duree et du lieu de traitement. Ces exigences particulieres ne s’appliquent pas: – aux SACS POUR SOLUTION DE DIALYSE preproduite, – aux CIRCUITS DE LA SOLUTION DE DIALYSE, – au CONCENTRE DE SOLUTION DE DIALYSE, – aux systemes d’alimentation en EAU DE DIALYSE (voir l’ISO 23500-2 [1]) , – aux SYSTEMES DE TRANSMISSION CENTRALISES pour CONCENTRES DE SOLUTION DE DIALYSE, decrits comme des systemes de melange en vrac de concentres dans un centre de dialyse, – aux appareils utilises pour l’HEMODIALYSE (voir l’IEC 60601-2-16 [2]). LIEC 60601-2-39:2024 annule et remplace la troisieme edition parue en 2018. Cette edition constitue une revision technique. Cette edition inclut les modifications techniques majeures suivantes par rapport a l’edition precedente: a) mise a jour des references a l’IEC 60601-1:2005, l’IEC 60601-1:2005/AMD1:2012 et l’IEC 60601 1:2005/AMD2:2020, des references a l’IEC 60601 1 2:2014 et l’IEC 60601 1 2:2014/AMD1:2020, des references a l’IEC 60601-1-8:2006, l’IEC 60601 1 8:2006/AMD1:2012 et l’IEC 60601 1 8:2006/AMD2:2020,des references a l’IEC 60601 1 9:2007, l’IEC 60601