Medical electrical equipment Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment Published (Edition 3, 2026)

Abstract

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[4], an oxygen concentrator[12] or liquid oxygen equipment[7].

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+AMD2:2020, 7.2.13 and 8.4.1.

NOTE 2 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.

General information

Status: Published

Publication date : 2026-04

Stage : International Standard published

Edition : 3

Number of pages : 59

ISO

IEC/TS 61400-4-1:2026

ISO 2507:2026

ISO 22095-2:2026

ISO 80601-2-67:2026-ISW120219

ISO 13503-9:2026-ISW120348

ISO 12052:2026-ISW120351

ISO 9849:2026

ISO 19223-3:2025

ISO 11367:2025-ISW120952

ISO 37302:2025

ISO 4345:2025-ISW120988

ISO 11093-2:2025-ISW121000