What is ISO 80601 ‑ 2 ‑ 67 about?
ISO 80601 discusses medical electrical equipment. ISO 80601 ‑ 2 ‑ 67 outlines the basic safety and essential performance of oxygen conserving equipment, hereafter referred to as ME equipment, in combination with its accessories. Oxygen conserving equipment is 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.
ISO 80601 ‑ 2 ‑ 67 is also applicable to conserving equipment that is incorporated with other equipment.
ISO 80601 ‑ 2 ‑ 67 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.
Who is ISO 80601 ‑ 2 ‑ 67 for?
ISO 80601 ‑ 2 ‑ 67 on oxygen-conserving equipment is useful for:
Manufacturers of oxygen-conserving equipment
Hospitals
Test centres for oxygen-conserving equipment
Operators of oxygen-conserving equipment
Regulatory authorities
Why should you use ISO 80601 ‑ 2 ‑ 67