TS EN ISO 80601-2-55 Electrical Medical Equipment - Part 2-55: Basic Safety and Required Performance of Respiratory Gas Monitors

The BS EN 21647 standard was developed by the British Standards Institute (BSI), which describes the basic safety and essential performance and features of testing respiratory gas monitors, which are among the electrical medical equipment.

This standard, published by the Turkish Standards Institute (TSE) in our country, was later revoked and the ISO 80601-2-75 standard prepared by the International Standards Organization (ISO) was published with the following title: TS EN ISO 80601-2-55 Electrical medical equipment - Department 2-55: Specific features of basic safety and required performance of respiratory gas monitors.

This standard describes the features for basic safety and required performance of respiratory gas monitors designed for continuous operation for use with the patient.

This part of the international 80601 standard applies to the basic safety and basic performance of gas monitors designed for use in professional healthcare facilities, emergency medical services and home healthcare environments. This standard sets requirements for: anesthetic gas monitoring, carbon dioxide monitoring and oxygen monitoring.

A breathing gas monitor can be standalone equipment or integrated into another equipment. For example, it can be used as a workstation or ventilator. This standard does not apply to a breathing gas monitor intended for use with flammable anesthetic agents.

Risks specific to the intended physiological function of medical devices or medical systems covered by this standard are outside the scope of this standard. In this case, the IEC 60601‑1 standard should be considered (Electrical medical equipment - Part 1: General rules for basic safety and required performance).

Within the scope of breathing apparatus compatibility tests carried out by our organization EUROLAB, testing services in accordance with TS EN ISO 80601-2-55 standard are also provided.