Standards Development

Scope

201.1 Scope, object and related standards 

NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.

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

NOTE 2   The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020.

201.1.1 Scope

IEC 60601-1:2005+AMD1:2012+AMD2:2020, 1.1 is replaced by:

This document specifies requirements for the basic safety and essential performance of an oxygen concentrator in combination with its accessories, hereafter referred to as ME equipment, intended to increase the oxygen concentration of gas intended to be delivered to a single patient. Such oxygen concentrators are typically intended for use in the home healthcare environment by a single patient in various environments including any private and public transportation as well as in commercial aircraft.

NOTE 1 Such oxygen concentrators can also be used in professional healthcare facilities.

This document is applicable to a transit-operable and non-transit-operable oxygen concentrator. This document is applicable to an oxygen concentrator integrated into or used with other medical devices, ME equipment or ME systems.

EXAMPLE 1 An oxygen concentrator with integrated oxygen conserving equipment  function or humidifier function.

EXAMPLE 2 An oxygen concentrator used with a flowmeter stand.

EXAMPLE 3 An oxygen concentrator as part of an anaesthetic system for use in areas with limited logistical supplies of electricity and anaesthetic gases[2].

EXAMPLE 4 An oxygen concentrator with an integrated liquid reservoir function or gas cylinder filling system function.

This document is also applicable to those accessories intended by their manufacturer to be connected to an oxygen concentrator, where the characteristics of those accessories can affect the basic safety or essential performance of the oxygen concentrator.

NOTE 2 Such accessories can include, but are not limited to, masks, cannulae, extension tubing, humidifiers, carts, carrying cases, external power sources and oxygen conserving equipment.

This document does not specify requirements for oxygen concentrators for use with a medical gas pipeline system.

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 document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard.

NOTE 3 See also 4.2 of the general standard.

201.1.2 Object

IEC 60601-1:2005+AMD1:2012+AMD2:2020, 1.2 is replaced by:

The object of this document is to establish particular basic safety and essential performance requirements for an oxygen concentrator (as defined in 201.3.202) and its accessories.

NOTE 1 Accessories are included because the combination of the oxygen concentrator and the accessories needs to be adequately safe. Accessories can have a significant impact on the basic safety or essential performance of an oxygen concentrator.

NOTE 2 This document has been prepared to address the relevant essential principles[8] and labelling[9] guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex BB.

NOTE 3 This document has been prepared to address the relevant essential principles of safety and performance of ISO 16142-1:2016 as indicated in Annex CC.

NOTE 4 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745[7] as indicated in Annex DD.

201.1.3 Collateral standards

IEC 60601-1:2005+AMD1:2012+AMD2: 2020, 1.3 applies with the following addition:

IEC 60601-1-2:2014+AMD1:2020, IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 and IEC 60601‑1‑11:2015+AMD1:2020 apply as modified in Clauses 202, 206 and 211 respectively. IEC 60601-1-3:2008+AMD1:2013 and IEC 60601-1-9 does not apply. All other published collateral standards in the IEC 60601‑-1 series apply as published.

201.1.4 Particular standards

Replacement:

In the IEC 60601 series, particular standards define basic safety and essential performance requirements, and may modify, replace or delete requirements contained in the general standard and collateral standards as appropriate for the particular ME equipment under consideration.

A requirement of a particular standard takes priority over the general standard.

For brevity, IEC 60601-1+AMD1:2012+AMD2:2020 is referred to in this 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 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, 211.4 in this document addresses the content of Clause 4 of the IEC 60601-1-11collateral 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 general standard 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 general standard or applicable collateral standard.

— "Amendment" means that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this document.

Clauses, 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 3.147, 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, e.g. 202 for IEC 60601-1-2, 211 for IEC 60601-1-11, etc.

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

Where there is no corresponding clause or subclause in this document, the clause or subclause of the general standard or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of the general standard or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this document.