EN 60601-1:1990, Clause 1 applies with the following amendment.
This European Standard provides particular requirements for modules which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant devices, to form an anaesthetic workstation to a given specification.
It is the intent of this European Standard that both anaesthetic workstations supplied complete and individual modules be commercially available to users to allow the configuration of an anaesthetic workstation to meet the needs of their clinical practice. To this end, this European Standard has been structured in such a way as to identify clearly particular requirements of specific modules currently available. Different configurations of anaesthetic workstations are illustrated in Table 101.
This European Standard also specifies the particular requirements for emergency anaesthetic equipment (see Table 102).
For the purpose of this European Standard a module is defined as a self-contained unit of an anaesthetic workstation that performs a specific task or class of tasks in support of the major function of the anaesthetic workstation.
Such modules are e.g. anaesthetic gas delivery, anaesthetic vapour delivery, anaesthetic ventilators, anaesthetic breathing systems, anaesthetic gas scavenging systems (AGSS), specific monitoring, alarm and protection modules.
This European Standard also specifies particular requirements for the transfer and receiving system of an active AGSS intended to reduce the exposure of hospital personnel to anaesthetic gases and vapour and specifies the inlet flow conditions for which systems should be designed.
Although this European Standard does not specify the provision of patient monitors, attention is drawn to recommendations for patient monitoring during anaesthesia made by many national clinical and regulatory bodies.
Manufacturers of anaesthetic workstations are encouraged to make provision for additional monitors as well as for devices for the intravenous administration of drugs (see Annex SS "Bibliography" for appropriate equipment standards) so that the user can assimilate more easily the data output and so that the alarm function of the various monitors can be integrated.
BS EN 740:1999 history
2013BS EN ISO 80601-2-13:2012 Medical electrical equipment. Particular requirements for basic safety and essential performance of an anaesthetic workstation
2007BS EN 60601-2-13:2006 Medical electrical equipment - Particular requirements for the safety and essential performance of anaesthetic systems
1999BS EN 740:1999 Anaesthetic workstations and their modules - Particular requirements