BS EN ISO 80601-2-67:2020

This standard BS EN ISO 80601-2-67:2020 Medical electrical equipment is classified in these ICS categories:

• 11.040.10 Anaesthetic, respiratory and reanimation equipment

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

IEC 60601‑1:2005+AMD1:2012, 1.1 is replaced by:

This document is applicable to the basic safety and essential performance of oxygen conserving equipment, hereafter referred to as ME equipment, in combination with its accessories intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the patient's inspiratory cycle, when used in the home healthcare environment. Oxygen conserving equipment is typically used by a lay operator.

NOTE 1 Conserving equipment can also be used in professional health care facilities.

This document is also applicable to conserving equipment that is incorporated with other equipment.

EXAMPLE

Conserving equipment combined with a pressure regulator^[2], an oxygen concentrator^[7] or liquid oxygen equipment^[4].

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

This document is intended to clarify the difference in operation of various conserving equipment models, as well as between the operation of conserving equipment and continuous flow oxygen equipment, by requiring standardized performance testing and labelling.

This document is only applicable to active devices (e.g. pneumatically or electrically powered) and is not applicable to non-active devices (e.g. reservoir cannulas).

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, 7.2.13 and 8.4.1.

NOTE 2 Additional information can be found in IEC 60601‑1:2005+AMD1:2012, 4.2.

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 conserving equipment [as defined in 201.3.201] and its accessories.

NOTE 1 Accessories are included because accessories can have a significant impact on the basic safety or essential performance of conserving equipment.

NOTE 2 This document has been prepared to address the relevant essential principles^[11] and labelling^[12] guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex BB.

NOTE 3 This document has been prepared to address the relevant essential principles of safety and performance of ISO 16142‑1:2016 as indicated in Annex CC.

NOTE 4 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745^[10] as indicated in Annex DD.

201.1.3 Collateral standards

IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 1.3 applies with the following addition:

IEC 60601‑1‑2+AMD1:2020 and IEC 60601‑1‑6+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:— 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, 206.4 in this document addresses the content of Clause 4 of the IEC 60601‑1‑6 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 3.147, 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, 206 for IEC 60601‑1‑6, 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.