Anesthesia machine, anesthesia system, anesthesia workstation; (HS: 9018); (ICS: 11.040.10)
National Standard of the P.R.C., Medical Electrical Equipment — Part 2-13: Particular Requirements For Basic Safety And Essential Performance Of An Anaesthetic Workstation (87 page(s), in Chinese)
This standard is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator.
This standard specifies particular requirements for a complete anaesthetic workstation and the following anaesthetic workstation components which, although considered as individual devices in their own, may be utilized, in conjunction with other relevant anaesthetic workstation components, to form an anaesthetic workstation:
· anaesthetic gas delivery system;
· anaesthetic breathing system;
· anaesthetic gas scavenging system;
· anaesthetic vapour delivery system;
· anaesthetic ventilator;
· monitoring equipment;
· alarm system;
· protection device
This standard is also applicable to those accessories intended by their manufacturer to be connected to an anaesthetic workstation where the characteristics of those accessories can affect the basic safety and essential performance of the anaesthetic workstation.
This standard is not applicable to any anaesthetic workstation intended for use with flammable anaesthetic agents, as determined by annex BB.