201.1.1 Scope

This part of IEC 60601 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[1])1,

• 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[2]).

201.1.2 Object

The object of this document is to establish particular basic safety and essential performance requirements for pd equipment.

201.1.3 Collateral standards

This document refers to those applicable collateral standards that are listed in Clause 2 of IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 and Clause 201.2 of this document.

IEC 60601‑1‑2:2014 and IEC 60601‑1‑2:2014/AMD1:2020, IEC 60601‑1‑8:2006, IEC 60601‑1‑8:2006/AMD1:2012 and IEC 60601‑1‑8:2006/AMD2:2020, IEC 60601‑1‑10:2007, IEC 60601‑1‑10:2007/AMD1:2013 and IEC 60601‑1‑10:2007/AMD2:2020, IEC 60601‑1‑11:2015 and IEC 60601‑1‑11:2015/AMD1:2020 apply as modified in Clauses 202, 208, 210 and 211.

IEC 60601‑1‑3 does not apply. IEC 60601‑1‑9:2007, IEC 60601‑1‑9:2007/AMD1:2013 and IEC 60601‑1‑9:2007/AMD2:2020 does not apply as noted in Clause 209.

All other published collateral standards in the IEC 60601‑1 series apply as published.

201.1.4 Particular standards

In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 and collateral standards as appropriate for the particular me equipment under consideration, and may add other basic safety and essential performance requirements.

A requirement of a particular standard takes priority over IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020.

The numbering of clauses and subclauses of this document corresponds to that of IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 with the prefix "201" (e.g. 201.1 in this document addresses the content of Clause 1 of IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020) or applicable collateral standard with the prefix "20x" where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this document addresses the content of Clause 4 of the IEC 60601‑1‑2 collateral standard, 203.4 in this document addresses the content of Clause 4 of the IEC 60601‑1‑3 collateral standard, etc.). The changes to the text of IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 are specified by the use of the following words:

"Replacement" means that the clause or subclause of IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 or applicable collateral standard is replaced completely by the text of this document.

"Addition" means that the text of this document is additional to the requirements of IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 or applicable collateral standard.

"Amendment" means that the clause or subclause of IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 or applicable collateral standard is amended as indicated by the text of this document.

Subclauses, figures or tables which are additional to those of IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 are numbered starting from 201.101. However, due to the fact that definitions in IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 are numbered 3.1 through 3.154, additional definitions in this document are numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.

Subclauses, figures or tables which are additional to those of a collateral standard are numbered starting from 20x, where "x" is the number of the collateral standard, for example 202 for IEC 60601‑1‑2, 203 for IEC 60601‑1‑3, etc.

The term "this document" is used to make reference to IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020, any applicable collateral standards and this document taken together.

Where there is no corresponding clause or subclause in this document, the clause or subclause of IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020 or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this document.