IEC 60601‑1:2005+AMD1:2012+AMD2:2020, Clause 1 applies, except as follows:
Replacement:
NOTE 1 There is guidance or rationale for this subclause contained in AA.2.1.
This document applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as ME equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender.
These requirements apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders regardless of their origin (i.e. including remanufactured products).
The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of patients in professional healthcare institutions as well as patients in the home healthcare environment and the emergency medical services environment.
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 says 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 201.11.1.2.2, IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 2 See also IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 4.2.
This document can also be applied to ME equipment and their accessories used for compensation or alleviation of disease, injury, or disability.
This document is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that require a blood sample from the patient.
This document is not applicable to pulse oximeter equipment intended solely for foetal use.
This document is not applicable to remote or slave (secondary) equipment that displays SpO2 values that are located outside of the patient environment.
NOTE 3 ME equipment that provides selection between diagnostic and monitoring functions is expected to meet the appropriate requirements of this document when configured for that function.
This document is applicable to pulse oximeter equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician’s office, such as in ambulances and air transport. Additional standards can apply to pulse oximeter equipment for those environments of use.
This document is a particular standard in the IEC 60601‑1 and ISO and IEC 80601 series of standards.
Replacement:
The object of this document is to establish particular basic safety and essential performance requirements for pulse oximeter equipment [as defined in 201.3.253] and its accessories.
NOTE 1 Accessories are included because the combination of the pulse oximeter monitor and the accessories needs to be adequately safe. Accessories can have a significant impact on the basic safety or essential performance of pulse oximeter equipment.
NOTE 2 This document has been prepared to address the relevant essential principles[25] and labelling[26] guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex KK.
NOTE 3 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745[27].
Amendment (add after existing text):
This document refers to those applicable collateral standards that are listed in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, Clause 2 and Clause 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, IEC 60601‑1‑11+AMD1:2020 and IEC 60601‑1‑12+AMD1:2020 apply as modified in Clauses 202, 206, 208, 211 and 212, 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.
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 particular ME equipment under consideration, and may add other basic safety or essential performance requirements.
NOTE The general standard is IEC 60601‑1:2005+AMD1:2012+AMD2:2020.
A requirement of a particular standard takes priority over the general standard or the collateral standards.
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 those 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 “2xx” where xx 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 abbreviated 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 or figures that are additional to those of the general standard are numbered starting from 201.101, additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses or figures that are additional to those of a collateral standard are numbered starting from 2xx, where “x” is the number of the collateral standard (e.g. 202 for IEC 60601‑1‑2, 203 for IEC 60601‑1‑3, 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 section, 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 particular document.
ISO 80601-2-61
EN ISO 80601-2-61