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?
Long-term oxygen therapy has been demonstrated in randomized, controlled clinical trials to prolong survival in patients with chronic respiratory disease and documented hypoxemia. Long-term oxygen therapy includes gaseous oxygen from cylinders or from liquid oxygen and oxygen from an oxygen concentrator.
ISO 80601‑2‑67 provides details on an acceptable degree of basic safety, essential performance, and protection against electrical hazards, mechanical hazards, unwanted and excessive radiation hazards, and excessive temperatures and other hazards for oxygen-conserving equipment. This minimizes risk to the patient and operator when using oxygen-conserving equipment.
What’s changed since the last update?
BS EN ISO 80601‑2‑67:2020 supersedes ISO 80601‑2‑67:2014, which has been withdrawn. BS EN ISO 80601‑2‑67:2020 has some technical changes with respect to ISO 80601‑2‑67:2014.
These include:
- Clarified the accessibility of inlet and outlet connectors
- Formatted to provide a unique identifier for each requirement
- Harmonization with the ‘A2 project’ of the general standard