IEC 60601‑1:2005+AMD1:2012+AMD2:2020, Clause 1 applies, except as follows:
NOTE The general standard is IEC 60601‑1:2005+AMD1:2012+AMD2:2020.
201.1.1 Scope
NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.1.
IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 1.1 is replaced by:
This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions.
Sleep apnoea breathing therapy equipment is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the therapy settings.
This document excludes sleep apnoea breathing therapy equipment intended for use with neonates.
This document is applicable to ME equipment or an ME system intended for those patients who are not dependent on artificial ventilation. This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on artificial ventilation such as patients with central sleep apnoea.
This document is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment.
Masks and application accessories intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this document.
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 2 See also 4.2 of the general standard.
This document does not specify the requirements for:
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ventilators or accessories intended for critical care ventilators for ventilator-dependent patients, which are given in ISO 80601‑2‑12.
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ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13.
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ventilators or accessories intended for home care ventilators for ventilator-dependent patients, which are given in ISO 80601‑2‑72.
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ventilators or accessories intended for emergency and transport, which are given in ISO 80601‑2‑84.
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ventilators or accessories intended for home-care ventilatory support, which are given in ISO 80601‑2‑79 and ISO 80601‑2‑80.
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high-frequency ventilators[23], which are given in ISO 80601‑2‑87.
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respiratory high flow equipment, which are given in ISO 80601‑2‑90;
NOTE 3 ISO 80601-2-80 ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.
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user-powered resuscitators, which are given in ISO 10651‑4;
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gas-powered emergency resuscitators, which are given in ISO 10651‑5;
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oxygen therapy constant flow ME equipment; and
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cuirass or “iron-lung” ventilation equipment.
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 sleep apnoea breathing therapy equipment (as defined in 201.3.259).
NOTE 1 This document has been prepared to address the relevant essential principles[20] and labelling principles[21] guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex CC.
NOTE 2 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745[19].
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, 206 and 211 respectively. IEC 60601‑1‑3 and IEC 60601‑1‑9 do 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 specify 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.
