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ADOPTED_FROM:EN ISO 80601-2-13:2022 This document 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 document 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 (AGSS);
anaesthetic vapour delivery system;
anaesthetic ventilator;
monitoring equipment;
alarm system;
protection device.

NOTE 1        Monitoring equipment, alarm systems and protection devices are summarized in Table AA.1.
An anaesthetic workstation supplied complete and its individual components are considered as ME equipment or ME systems with regard to the general standard.
NOTE 2        The applicability of this document is indicated in Table AA.2.
This document 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 or its accessories 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 including accessories, as relevant.
Hazards inherent in the intended physiological function of an anaesthetic workstation and its individual components including accessories within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 3        See also IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
This document is not applicable to any anaesthetic workstation intended for use with flammable anaesthetic agents, as determined by Annex BB.
 

Document History

  1. NS-EN ISO 80601-2-13:2022

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    Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2022)

    • Most Recent
  2. NS-EN ISO 80601-2-13:2012/A2:2019


    Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation — Amendment 2 (ISO 80601-2-13:2011/Amd 2:2018)

    • Historical Version
  3. NS-EN ISO 80601-2-13:2012/A1:2019


    Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation — Amendment 1 (ISO 80601-2-13:2011/Amd 1:2015)

    • Historical Version
  4. NS-EN ISO 80601-2-13:2012


    Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011)

    • Historical Version
  5. NS-EN ISO 8835-3:2009/A1:2010


    Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007/Amd 1:2010)

    • Historical Version
  6. NS-EN ISO 8835-2:2009


    Inhalational anaesthesia systems — Part 2: Anaesthetic breathing systems (ISO 8835-2:2007)

    • Historical Version
  7. NS-EN ISO 8835-4:2009


    Inhalational anaesthesia systems — Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)

    • Historical Version
  8. NS-EN ISO 8835-5:2009


    Inhalational anaesthesia systems — Part 5: Anaesthetic ventilators (ISO 8835-5:2004)

    • Historical Version
  9. NS-EN ISO 8835-3:2009


    Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007)

    • Historical Version
  10. NS-EN ISO 8835-2:2007


    Inhalational anaesthesia systems — Part 2: Anaesthetic breathing systems (ISO 8835-2:2007)

    • Historical Version
  11. NS-EN ISO 8835-3:2007


    Inhalational anaesthesia systems — Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007)

    • Historical Version
  12. NS-EN ISO 8835-5:2004/AC:2006


    Inhalational anaesthesia systems — Part 5: Anaesthetic ventilators (ISO 8835-5:2004)

    • Historical Version
  13. NS-EN ISO 8835-4:2004/AC:2006


    Inhalational anaesthesia systems — Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)

    • Historical Version
  14. NS-EN ISO 8835-5:2004/AC:2004


    Inhalational anaesthesia systems — Part 5: Anaesthesia ventilators (ISO 8835-5:2004)

    • Historical Version
  15. NS-EN ISO 8835-4:2004/AC:2004


    Inhalational anaesthesia systems — Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)

    • Historical Version
  16. NS-EN ISO 8835-5:2004


    Inhalational anaesthesia systems — Part 5: Anaesthesia ventilators (ISO 8835-5:2004)

    • Historical Version
  17. NS-EN ISO 8835-4:2004


    Inhalational anaesthesia systems — Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)

    • Historical Version
  18. NS-EN 740:1998/A1:2004


    Anaesthetic workstations and their modules — Particular requirements

    • Historical Version
  19. NS-EN 740:1998


    Anaesthetic workstations and their modules — Particular requirements (Including Corrigendum AC:1998)

    • Historical Version