The ISO 80601-2-13 standard, developed by the International Standards Organization (ISO), describes the basic safety and performance characteristics and test methods of anesthesia workstations. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 80601-2-13 Electrical medical devices - Part 2-13: Special rules for basic performance and basic safety of anesthesia workstations.
This standard sets criteria for the basic safety and basic performance of an anesthetic workstation for the administration of inhalation anesthesia while being constantly accompanied by a professional operator. This standard describes specific requirements for the following components that can be used in conjunction with other relevant anesthetic workstation components: anesthetic gas delivery system, anesthetic breathing system, anesthetic gas purification system, anesthetic vapor delivery system, anesthetic ventilator, imaging equipment, alarm system and protection device.
The TS EN ISO 80601-2-13 standard also includes the accessories that are intended to be connected to an anesthetic workstation by the manufacturers. The features of these accessories affect the basic safety and basic performance of the anesthetic workstation.
Hazards in the intended physiological function of medical devices or medical systems within the scope of TS EN ISO 80601-2-13 standard are not covered by the TS EN 60601-1 standard.
Today, the modern integrated anesthesia workstation is designed to be a complete anesthesia and breathing gas delivery and monitoring system. Advanced ventilation capabilities are combined with gas delivery and agent evaporation, patient monitoring and information management to create an integrated anesthetic care.
Our organization also provides businesses with laboratory services, including ISO 80601-2-13 standardized testing and identification of basic safety and performance specifications for anesthesia workstations.
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