CAN/CSA-C22.2 No. 60601-2-13:02

This National Standard of Canada is based on International Standard IEC 60601-2-13:1998 (second edition, 1998-05). 1 Scope and object This clause of the General Standard applies, except as follows: Addition 1.2 This Particular Standard presents particular requirements for ANAESTHETIC WORKSTATIONS for inhalational anaesthesia intended for human use supplied complete, as well as particular requirements for individual devices which are intended to be part of an ANAESTHETIC WORKSTATION. It is the intent of this Particular Standard that both complete ANAESTHETIC WORKSTATIONS and individual devices be commercially available to allow users to configure an ANAESTHETIC WORKSTATION to meet the needs of their clinical practice in conformance with their national regulations. To this end the standard has been structured in such a way as to clearly define interfaces and to identify particular requirements pertinent to specific devices currently available. Attention is drawn to recommendations for patient monitoring during anaesthesia made by many national clinical and regulatory bodies. These recommendations include, but are not limited to, monitoring of the patient?s electrocardiogram, blood pressure, anaesthetic agent concentration, end-tidal CO, body temperature, and pulse oximetry. NOTE - Although this Particular Standard does not mandate the use of the MONITORING DEVICEs referred to in the paragraph above, manufacturers of ANAESTHETIC WORKSTATIONS are encouraged to make provision for such monitors so that the user can more easily assimilate their data output and so that the alarm function of the various monitors can be integrated. To facilitate data transfer capability between different MONITORING DEVICES, a ?bus? or data transfer system may be used. ANAESTHETIC WORKSTATIONS and/or their components intended for use with flammable anaesthetic agents are not covered by this standard, nor are dental analgesia apparatus.