Medical electrical equipment. Anaesthetic workstation. Technical requirements for public procurement

2Scope / Description

This standard establishes the basic technical requirements for inhalation anesthesia devices (hereinafter referred to as anesthesia systems) and is intended for use by authorized representatives of government customers when preparing technical specifications for tender documentation during procurement of high-tech medical equipment (HME) for government needs ([1], [2] and (3)). This standard applies to tenders for government procurement of HME for the provision of high-tech medical care ([4] and (5)). This standard does not apply to non-governmental procurement of medical equipment. The standard establishes technical requirements for anesthesia systems as a whole, as well as for the following components of anesthesia systems, which may be considered the main components and supplied separately for further use with other or existing components to implement an anesthesia system of the declared configuration, taking into account the specific requirements of a particular medical institution. The basic composition of a modern anesthesia system is as follows: anesthetic gas delivery system; anesthesia breathing circuit; Anesthetic gas extraction system (including receiving, transmitting, and transport systems); anesthetic vaporizer; anesthesia machine for artificial lung ventilation; monitoring equipment; alarm system; safety devices. The anesthesia system provides inhalation anesthesia for adults and children over 1 year of age in the anesthesiology and surgery departments of medical institutions of any capacity, taking into account the stated specifications.