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About This Item

 

Full Description

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.

 

Document History

  1. ISO 80601-2-13:2011

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

    • Most Recent
  2. ISO/DIS 80601-2-13


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

    • Historical Version
  3. ISO 8835-3:2007


    Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems

    • Historical Version
  4. ISO 8835-2:2007


    Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems

    • Historical Version
  5. ISO 8835-4:2004


    Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices

    • Historical Version
  6. ISO 8835-5:2004


    Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators

    • Historical Version
  7. IEC 60601-2-13 Ed. 3.0 en:2003


    Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems

    • Historical Version
  8. ISO 8835-2:1999


    Inhalational anaesthesia systems -- Part 2: Anaesthetic breathing systems for adults

    • Historical Version
  9. ISO 8835-3:1997


    Inhalational anaesthesia systems -- Part 3: Anaesthetic gas scavenging systems -- Transfer and receiving systems

    • Historical Version
 

Amendments & Errata

  1. ISO 80601-2-13:2011/Amd1:2015


    - Amendment 1