BS EN ISO 80601-2-61:2019

This standard BS EN ISO 80601-2-61:2019 Medical electrical equipment is classified in these ICS categories:

• 11.040.55 Diagnostic equipment
• 11.040.10 Anaesthetic, respiratory and reanimation equipment

IEC 60601‐1:2005+AMD1:2012, Clause 1 applies, except as follows:

201.1.1 * Scope

Replacement:

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 also apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders, which have been reprocessed.

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.

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.

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 201.11 and in 7.2.13 and 8.4.1 of the general standard.

NOTE 1 See also 4.2 of the general standard. “The general standard” is IEC 60601‐1:2005+AMD1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.

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 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 2 Me equipment that provides selection between diagnostic and monitoring functions is expected to meet the requirements of the appropriate 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 pulse oximeter equipment for those environments of use.

This document is a particular standard in the IEC 60601‐1 and ISO/IEC 80601 series of standards.

201.1.2 Object

Subclause 1.2 of the general standard is replaced by:

The object of this document is to establish particular basic safety and essential performance requirements for pulse oximeter equipment [as defined in 201.3.217] and its accessories.

NOTE 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.

201.1.3 Collateral standards

IEC 60601‐1:2005+AMD1:2012, subclause 1.3 applies with the following addition:

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

IEC 60601‐1‐2, IEC 60601‐1‐6, IEC 60601‐1‐8, IEC 60601‐1‐11 and IEC 60601‐1‐12 apply as modified in Clauses 202, 206, 208, 211 and 212 respectively. IEC 60601‐1‐3^[2] does not apply. All other published collateral standards in the IEC 60601‐1 series apply as published.

201.1.4 Particular standards

IEC 60601‐1:2005+AMD1:2012, subclause 1.4 is replaced by:

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.

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

For brevity, IEC 60601‐1:2005+AMD1:2012 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 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.