The ISO 80601-2-55 standard, developed by the International Standards Organization (ISO), describes the basic safety and performance characteristics and test methods of respiratory gas monitors. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 80601-2-55 Electrical medical equipment - Part 2-55: Certain features related to the basic safety and required performance of respiratory gas monitors. The basis of this standard is the BS EN 21647 standard developed by the British Standards Institute (BSI).
The ISO 80601-2-55 standard describes specific requirements for the basic safety and essential performance of a respiratory gas monitor, which is considered a medical device and designed for continuous use with a patient. This standard primarily specifies requirements for anesthetic gas monitoring, carbon dioxide monitoring, and oxygen monitoring. A respiratory gas monitor can be a standalone piece of equipment or integrated into other equipment, such as an anesthetic workstation or a ventilator (breathing device).
This standard does not apply to a breathing gas monitor intended for use with flammable anesthetic agents.
Hazards in the intended physiological function of medical devices or medical systems covered by the ISO 80601-2-55 standard are not covered by certain requirements, except for the TS EN 60601-1 Electrical medical equipment - Part 1: General rules standard for basic safety and required performance.
In short, this international standard applies to the basic safety and basic performance of gas monitors designed for use in professional healthcare facilities, emergency medical centers and home healthcare environments.
Our organization also provides basic safety and performance features and testing services of ISO 80601-2-55 breathing gas monitors to enterprises within the scope of laboratory services.
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