Standards Development

Scope

201.1 Scope, object and related standards 

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

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

201.1.1 Scope

Replacement:

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

This document applies to the basic safety and essential performance of a humidifier, also hereafter referred to as ME equipment, in combination with its accessories, the combination also hereafter referred to as ME system.

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

EXAMPLE 1 Heated breathing tubes (heated-wire breathing tubes) or ME equipment intended to control these heated breathing tubes (heated breathing tube controllers).

NOTE 2 Heated breathing tubes and their controllers are ME equipment and are subject to the requirements of IEC 60601‑1.

NOTE 3 ISO 5367 specifies other safety and performance requirements for breathing tubes.This document includes requirements for the different medical uses of humidification, such as invasive ventilation, non-invasive ventilation, nasal high-flow therapy, and obstructive sleep apnoea therapy, as well as humidification therapy for tracheostomy patients.

NOTE 4 A humidifier can be integrated into other equipment. When this is the case, the requirements of the other equipment also apply to the humidifier.

EXAMPLE 2 Heated humidifier incorporated into a critical care ventilator where ISO 80601‑2-12 also applies.

EXAMPLE 3 Heated humidifier incorporated into a homecare ventilator for dependent patients where ISO 80601‑2‑72 also applies.

EXAMPLE 4 Heated humidifier incorporated into sleep apnoea therapy equipment where ISO 80601‑2‑70 also applies.

EXAMPLE 5 Heated humidifier incorporated into ventilatory support equipment where either ISO 80601-2-79 or ISO 80601-2-80 also apply.

EXAMPLE 6 Heated humidifier incorporated into respiratory high-flow therapy equipment where ISO 80601‑2‑90 also applies.

This document also includes requirements for an active HME (heat and moisture exchanger), ME equipment which actively adds heat and moisture to increase the humidity level of the gas delivered from the HME to the patient. This document is not applicable to a passive HME, which returns a portion of the expired moisture and heat of the patient to the respiratory tract during inspiration without adding heat or moisture.

NOTE 5 ISO 9360‑1 and ISO 9360‑2 specify safety and performance requirements for a passive HME.

NOTE 6 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 IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.

NOTE 7 Additional information can be found in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 4.2.

This document does not specify the requirements for cold pass-over or cold bubble-through humidification devices, the requirements for which are given in ISO 20789.

This document is not applicable to equipment commonly referred to as “room humidifiers” or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant incubators to humidify the chamber air (i.e., are not directly connected to the patient).

This document is not applicable to nebulizers used for the delivery of a drug to patients.

NOTE 8 ISO 27427 specifies the safety and performance requirements for nebulizers and ISO 80601-2-94 for inhalational therapy nebulizer equipment.

201.1.2 Object

Replacement:

The object of this document is to establish particular basic safety and essential performance requirements for a humidifier, as defined in 201.3.23914, and its accessories.

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

NOTE 1 This document has been prepared to address the relevant essential principles and labelling guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex HHII.

NOTE 2 This document has been prepared to address the relevant essential principles of safety and performance of ISO 16142-1:2016.NOTE 23 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745.

201.1.3 Collateral standards

Addition (add after existing text):

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

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 and IEC 60601‑1‑11:2015+AMD1:2020 apply as modified in Clauses 202, 206, 208 and 211, respectively. IEC 60601‑1‑3:2008+AMD1:2013+AMD2:2021 and IEC 60601-1-9:2007+AMD1:2013+AMD2:2020 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 60601‑1:2005+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, 208.6 in this document addresses the content of Clause 6 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 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 3.154, 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, 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.