Standards Development

Scope

IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 1 applies, except as follows:

Replacement:

This document applies to the basic safety and essential performance of infusion pumps and volumetric infusion controllers in combination with their accessories, hereafter referred to as me equipment.

This document applies to administration sets and syringes insofar as their characteristics influence the basic safety or essential performance of infusion pumps and volumetric infusion controllers. However, this document does not specify requirements or tests for other aspects of administration sets or syringes intended for use with the mee.

note 1 — Guidance and rationale for this subclause are provided in Clause AA.1.1.

This document specifies the requirements for

a) infusion pumps including

1) volumetric infusion pumps

2) container pumps

b) volumetric infusion controllers

This document does not apply to the following:

c) devices specifically intended for diagnostic or non-therapeutic use;

d) devices for extracorporeal circulation of blood;

e) implantable devices;

f) Non-electrically driven portable infusion devices covered by ISO 28620;

g) Needle-based injections systems covered under ISO 11608;

h) me equipment specifically intended for diagnostic use within urodynamics (measurement of pressure-volume relationship of the urinary bladder when filled through a catheter with water); and

i) me equipment specifically intended for diagnostic use within male impotence testing (measurement of amount of liquid infused, necessary to maintain a preset pressure level for maintaining penile erection: cavernosometry, cavernosography);

note 2 — 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.

Hazards inherent in the intended physiological function of me equipment or me systems within the scope of this standard are not covered by specific requirements in this standard except in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.

note 3 — Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.

Replacement:

The object of this document is to establish basic safety and essential performance requirements for volumetric infusion controllers and infusion pumps including enteral nutrition pumps, subcutaneous pumps, body-worn pumps, syringe or container pumps, and volumetric infusion pumps, as defined in 201.3.xyz

Accessories are included because the combination of the infusion pump and the accessories needs to be adequately safe. Accessories can have a significant impact on the basic safety or essential performance of an infusion pump.

note 1: This document has been prepared to address the relevant essential principles[1] and labelling[2] guidance of the International Medical devices Regulators Forum (IMDRF) as indicated in Annex xx.

note 2: This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745 as indicated in Annex xx.

201.1.3 Collateral standards

Amendment (add after existing text):

This document refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this document.

note 1: The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020.

IEC 60601-1-2:2014+amd1:2020, IEC 60601-1-6:2010+amd1:2013+amd2:2020, IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, IEC 60601-1-10: 2007+amd1:2013+amd2:2020, IEC 60601-1-11:2015+AMD1:2020 and IEC 60601-1-12:2014+amd1:2020 apply as modified in Clauses 202, 206, 208, 210, 211 and 212 respectively. IEC 60601-1-3[4], IEC 60601-1-9[5], do not apply. All other published collateral standards in the IEC 60601-1 series apply as published.

Replacement:

In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard, including the collateral standards, as appropriate for the 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 or the collateral standards.

For brevity, IEC 60601-1:2005+AMD1:2012+AMD2:2020 is referred to in this particular document as the general standard. Collateral standards are referred to by their document number.

The numbering of clauses and subclauses of this document corresponds to that of the general standard with the prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x” where x is the final digits 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, 208.4 in this document addresses the content of Clause 4 of the IEC 60601-1-8 collateral standard, etc.) The changes to the text of the general standard are specified by the use of the following words:

"Replacement" means that the clause or subclause of the IEC 60601-1:2005+AMD1:2012+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 the IEC 60601-1:2005+AMD1:2012+AMD2:2020 or applicable collateral standard.

"Amendment" means that the clause or subclause of IEC 60601-1:2005+AMD1:2012+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 the general standard are numbered starting from 201.101. However, due to the fact that definitions in the general standard are numbered 3.1 through 3.139, additional definitions in this standard 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, e.g. 202 for IEC 60601‑1-2, 208 for IEC 60601-1-8, etc.

The term "this standard" is used to make reference to the general standard, any applicable collateral standards and this particular standard taken together.

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