Overview

This part of the IEC 60601 series of International Standards applies to all medical electrical equipment that is intended to deliver a peritoneal dialysis treatment to a patient, independent of the treatment duration and location. The scope of this document includes both medical electrical peritoneal dialysis equipment, hereinafter referred to as PD equipment, intended for use either by medical staff or under the supervision of medical experts, including PD equipment operated by the patient. This document specifies the minimum safety requirements for PD equipment. 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.) Furthermore, the following topics are not covered by the scope of this document: - pre-manufactured dialysing solution bags; - dialysing solution circuits; - dialysing solution concentrate; - dialysis water supply systems; - central delivery systems for dialysing solution concentrates; and - equipment used to perform hemodialysis. The standard differs from DIN EN IEC 60601-2-39 (VDE 0750-2-39):2020-05 as follows: 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. This document is principally aimed, but not exclusively, at manufacturers and users of PD equipment.

Document: references other documents

Responsible national committee

DKE/GUK 804.11 - Apparate für extrakorporale Zirkulations- und Infusionstechnik