ISO 80601-2-13:2011 Preview

Medical electrical equipment -- Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation

ISO/IEC 80601-2-13:2011 is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator.

ISO/IEC 80601-2-13:2011 specifies particular requirements for a complete anaesthetic workstation and the following anaesthetic workstation components which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant anaesthetic workstation components, to form an anaesthetic workstation to a given specification:

  • anaesthetic gas delivery system;
  • anaesthetic breathing system;
  • anaesthetic gas scavenging system;
  • anaesthetic vapour delivery system;
  • anaesthetic ventilator;
  • monitoring equipment;
  • alarm system;
  • protection device.

ISO/IEC 80601-2-13:2011 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.

If a clause or subclause is specifically intended to be applicable to anaesthetic workstation components only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to an anaesthetic workstation and its individual components, as relevant.

Hazards inherent in the intended physiological function of an anaesthetic workstation and its individual components within the scope of ISO/IEC 80601-2-13:2011 are not covered by specific requirements in ISO/IEC 80601-2-13:2011 except in 7.2.13 and 8.4.1 of IEC 60601-1:2005.

ISO/IEC 80601-2-13:2011 is not applicable to any anaesthetic workstation intended for use with flammable anaesthetic agents, as determined by Annex BB.


General information

  • Status :  Published
    Publication date : 2011-08
  • Edition : 1
    Number of pages : 99
  • :
    ISO/TC 121/SC 1
    Breathing attachments and anaesthetic machines
  • 11.040.10
    Anaesthetic, respiratory and reanimation equipment

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal:

Buy this standard

Format Language
PDF
Paper
  • CHF198

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)

Keep up to date with ISO

Sign up to our newsletter for the latest news, views and product information

 Subscribe