FprEN IEC 60601-2-39:2024

Medical electrical equipment - Part 2-39: Particular requirements for the basic safety and essential performance of peritoneal dialysis equipment FprEN IEC 60601-2-39:2024

Publication date:   Aug 9, 2024

Scope

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.