Medical electrical equipment - Particular requirements for the basic safety and essential performance of oxygen concentrator equipment
Medical electrical equipment - Particular requirements for the basic safety and essential performance of oxygen concentrator equipment
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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 centre...
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