Standards Development

Scope

201.1 Scope, object and related standards

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

201.1.1 Scope

Replacement:

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

This document is applicable to the basic safety and essential performance of a nebulizing system, that includes nebulizing equipment and a nebulizer, intended to alleviate the symptoms of patients by delivering an inhalational therapy to the respiratory tract of the patient. A Nebulizing system is typically intended for use in the home healthcare environment by lay operators as well as use in professional healthcare facilities.

This document includes:

–       nebulizers in nebulizing systems which are powered by pressurized gas; and

–       electrically powered nebulizers in nebulizing systems [e.g., spinning disc, ultrasonic, vibrating mesh (active and passive), and capillary devices].

This document includes nebulizing systems used during spontaneous breathing (e.g., handheld equipment applied via a mouthpiece) as well as systems which are included into a ventilatory breathing system of a ventilatory support equipment or ventilators for ventilator dependent patients.

This document includes nebulizing systems intended for use with adults, children, neonates and premature born.

This document includes nebulizing systems intended for the supply of drugs within ventilatory breathing systems.

This document does not apply to drug-specific nebulizers or their components (e.g., metered dose inhalers, metered liquid inhalers, dry powder inhalers).

This document does not apply to nebulizing systems without nebulizing equipment.

EXAMPLE A nebulizer using the inspiratory flow of gas to the patient as an energy source.

This document does not specify the requirements for respiratory humidifiers, the requirements for which are given in ISO 80601-2-74 or ISO 20789.

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

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.

NOTE See also 4.2 of the general standards.

201.1.2 Object

IEC 60601-1:2005, 1.2 is replaced by:

The object of this document is to establish particular basic safety and essential performance requirements for a nebulizing system (as defined in 201.3.231)

NOTE 1 This document has been prepared to address the relevant essential principles[17] and labelling[18] guidance’s of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex BB.

NOTE 3 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745[16] as indicated in Annex CC.

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 and IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 apply as modified in Clauses 202 and 206 respectively. IEC 60601-1-3:2008+AMD1:2013 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, 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 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.

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 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 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.