The ISO 80601-2-55 standard, developed by the International Standards Organization (ISO), describes certain features and test methods for the basic safety and required performance of electrical 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. This standard replaced the abolished TS EN ISO 21647 standard.
This standard describes specific requirements for the basic safety and basic performance of a breathing gas monitor, which is equipment intended to be continuously operated for use on the next patient. This standard sets requirements for: anesthetic gas monitoring, carbon dioxide monitoring, and oxygen monitoring.
The breathing gas monitor can be standalone equipment or integrated into other equipment as an anesthetic workstation or ventilator. 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 within the scope of the ISO 80601-2-55 standard are not covered by certain requirements in the IEC 60601 standard1 standard.
The purpose of this standard is to describe the basic safety and basic performance requirements for medical equipment.
Several standards with normative reference in the implementation of the ISO 80601-2-55 standard are: IEC 60601 1, IEC 60601‐1‐2, IEC 60601‐1‐6, IEC 60601‐1‐8, ISO 7000, ISO 7010, ISO 14937, ISO 15223‐1, ISO 17664 and ISO 80369.
Within the scope of laboratory services, our organization also provides testing services for the basic safety and required performance of electrical respiratory gas monitors in the ISO 80601-2-55 standard.
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