What is ISO 80601‑2‑69 about?
ISO 80601 discusses medical electrical equipment. ISO 80601‑2‑69 outlines the basic safety and essential performance of an oxygen concentrator in combination with its accessories, hereafter referred to as ME equipment. Oxygen concentrator equipment is intended to increase the oxygen concentration of gas intended to be delivered to a single patient.
ISO 80601‑2‑69 is applicable to a transit-operable and non-transit-operable oxygen concentrator. ISO 80601‑2‑69 is applicable to an oxygen concentrator integrated into or used with other medical devices, ME equipment or ME systems.
ISO 80601‑2‑69 is also applicable to those accessories intended by their manufacturer to be connected to an oxygen concentrator.
Note 1: Such oxygen concentrators can also be used in professional healthcare facilities
Note 2: Such accessories can include, but are not limited to, masks, cannulae, extension tubing, humidifiers, carts, carrying cases, external power sources and oxygen conserving equipment.
Who is ISO 80601‑2‑69 for?
ISO 80601‑2‑69 on oxygen concentrator equipment is useful for:
- Manufactures of oxygen concentrator equipment and their accessories.
- Test centres for medical electrical equipment
- Hospitals and non-hospital environments where oxygen concentrator equipment is used.
- Operators and end-users of oxygen concentrator equipment
Why should you use ISO 80601‑2‑69?
Oxygen supplementation can be part of the management of patients with chronic, acute-on-chronic, or acute respiratory disorders. The amount of supplemental oxygen depends on the individual patient’s needs under various conditions. The goal of long-term oxygen therapy is to keep the oxygen saturation above a target value in patients that require supplemental oxygen.
ISO 80601‑2‑69 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 concentrator equipment. This minimizes risk to the patient and operator when using oxygen concentrator equipment.
What’s changed since the last update?
BS EN ISO 80601‑2‑69:2020 supersedes ISO 80601‑2‑69:2014, which has been withdrawn, BS EN ISO 80601‑2‑69:2020 has some technical changes with respect to ISO 80601‑2‑69:2014.
These include:
- Changes to the low oxygen concentration alarm condition
- Changes to the gas outlet connector
- Changes to the test method for the filter for the delivered gas
- Reformatting to provide a unique identifier for each requirement
- Harmonization with the ‘A2 project’ of the general standard
