IEC 60601-2-39:2024
(Main)Medical electrical equipment - Part 2-39: Particular requirements for the basic safety and essential performance of peritoneal dialysis equipment
Medical electrical equipment - Part 2-39: Particular requirements for the basic safety and essential performance of peritoneal dialysis equipment
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.
Appareils électromédicaux - Partie 2-39: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de dialyse péritonéale
L'IEC 60601-2-39:2024 s’applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des APPAREILS EM DE DIALYSE PERITONEALE, désignés ci-après sous le terme d’APPAREILS DP. Elle s’applique aux APPAREILS DP destinés à être utilisés soit par le personnel médical soit sous la surveillance d’experts médicaux, y compris les APPAREILS DP mis en fonctionnement par le PATIENT, que les APPAREILS DP 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 de la SOLUTION DE DIALYSE des APPAREILS DP qui utilise la régénération de la SOLUTION DE DIALYSE ou des SYSTEMES DE TRANSMISSION CENTRALISES pour la SOLUTION DE DIALYSE. Il prend cependant en considération les exigences spécifiques de sécurité de ces APPAREILS DP relatives à la sécurité électrique et la sécurité du PATIENT.
Le présent document spécifie les exigences minimales de sécurité des APPAREILS DP. Les APPAREILS DP sont destinés à être utilisés par le personnel médical ou le PATIENT ou tout personnel formé et sous surveillance médicale.
Le présent document s’applique à tous les APPAREILS EM destinés à fournir un traitement par DIALYSE PERITONEALE au PATIENT, indépendamment de la durée et du lieu de traitement.
Ces exigences particulières ne s’appliquent pas:
– aux SACS POUR SOLUTION DE DIALYSE préproduite,
– aux CIRCUITS DE LA SOLUTION DE DIALYSE,
– au CONCENTRE DE SOLUTION DE DIALYSE,
– aux systèmes d’alimentation en EAU DE DIALYSE (voir l’ISO 23500-2 [1]) ,
– aux SYSTEMES DE TRANSMISSION CENTRALISES pour CONCENTRES DE SOLUTION DE DIALYSE, décrits comme des systèmes de mélange en vrac de concentrés dans un centre de dialyse,
– aux appareils utilisés pour l’HEMODIALYSE (voir l’IEC 60601-2-16 [2]).
L'IEC 60601-2-39:2024 annule et remplace la troisième 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) mise à jour des références à l’IEC 60601-1:2005, l’IEC 60601-1:2005/AMD1:2012 et l’IEC 60601 1:2005/AMD2:2020, des références à l’IEC 60601 1 2:2014 et l’IEC 60601 1 2:2014/AMD1:2020, des références à l’IEC 60601-1-8:2006, l’IEC 60601 1 8:2006/AMD1:2012 et l’IEC 60601 1 8:2006/AMD2:2020,des références à l’IEC 60601 1 9:2007, l’IEC 60601 1 9:2007/AMD1:2013 et l’IEC 60601 1 9:2007/AMD2:2020, des références à l’IEC 60601 1 10:2007, l’IEC 60601 1 10:2007/AMD1:2013 et l’IEC 60601 1 10:2007/AMD2:2020 et des références à l’IEC 60601 1 11:2015 et l’IEC 60601 1 11:2015/AMD1:2020;
b) prise en considération des PERFORMANCES ESSENTIELLES en CONDITION DE PREMIER DEFAUT concernant l’IEC 60601 1:2005/AMD1:2012/ISH1:2021;
c) inclusion des informations données dans le document 62D/1771A/INF concernant le 201.11.8;
d) inclusion des informations données dans le document 62D/1734/INF concernant les questions techniques de l’édition précédente;
e) inclusion des exigences de SECURITE (CYBERSECURITE);
f) ajouts liés à la préparation en ligne de la SOLUTION DP (DP EN LIGNE);
g) améliorations apportées à la définition de la PARTIE APPLIQUEE;
h) amélioration des articles/paragraphes traitant des exigences relatives aux performances essentielles;
i) améliorations en matière d’étiquetage;
j) autres améliorations techniques mineures;
k) améliorations d’ordre rédactionnel.
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IEC 60601-2-39 ®
Edition 4.0 2024-12
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-39: Particular requirements for the basic safety and essential performance
of peritoneal dialysis equipment
Appareils électromédicaux –
Partie 2-39: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de dialyse péritonéale
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IEC 60601-2-39 ®
Edition 4.0 2024-12
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-39: Particular requirements for the basic safety and essential
performance of peritoneal dialysis equipment
Appareils électromédicaux –
Partie 2-39: Exigences particulières pour la sécurité de base et les
performances essentielles des appareils de dialyse péritonéale
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.99 ISBN 978-2-8327-0010-5
– 2 – IEC 60601-2-39:2024 © IEC 2024
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 . 13
201.5 General requirements for testing ME EQUIPMENT . 17
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 17
201.7 ME EQUIPMENT identification, marking and documents . 17
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 22
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 22
201.10 Protection against unwanted and excessive radiation HAZARDS . 22
201.11 Protection against excessive temperatures and other HAZARDS . 22
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 25
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 28
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 28
201.15 Construction of ME EQUIPMENT . 30
201.16 * ME SYSTEMS . 31
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 32
202 Electromagnetic disturbances – Requirements and tests . 32
208 * General requirements, tests and guidance for ALARM SYSTEMS in MEDICAL
ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS . 33
209 Requirements for environmentally conscious design . 35
210 Requirements for the development of PHYSIOLOGIC CLOSED-LOOP
CONTROLLERS . 35
211 * Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL
SYSTEMS used in the HOME HEALTHCARE ENVIRONMENT . 35
Annexes . 36
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures . 37
Annex AA (informative) Particular guidance and rationale . 38
Bibliography . 52
Index of defined terms used in this document . 54
Figure AA.1 – Powered by SUPPLY MAINS only . 44
Figure AA.2 – Alarm at depletion of battery for limited functionality . 45
Figure AA.3 – Alarm before battery for limited functionality gets depleted (10 min
minimum) . 45
Figure AA.4 – Alarm before battery for limited functionality gets depleted (battery
lasting for equal or less than 10 min) . 46
Figure AA.5 – Alarm at battery depletion . 46
Figure AA.6 – Alarm before battery gets depleted (10 min minimum) . 47
Figure AA.7 – Example of a PD ME SYSTEM . 49
Table 201.101 – ESSENTIAL PERFORMANCE requirements . 13
– 4 – IEC 60601-2-39:2024 © IEC 2024
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-39: Particular requirements for the basic safety and essential
performance of peritoneal dialysis equipment
FOREWORD
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