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Full Description

ADOPTED_FROM:EN ISO 8835-4:2009 For the purposes of ISO 8835-4:2004, the requirements in IEC 60601-1:1988, Clause 1 apply except as follows. Addition: ISO 8835-4:2004 specifies particular requirements for the essential performance of anaesthetic vapour delivery devices (AVDDs), as defined in 3.1. ISO 8835-4:2004 is applicable to AVDDs which are a component of an anaesthetic system and are intended to be continuously operator-attended. ISO 8835-4:2004 gives specific requirements for AVDDs which are supplementary to the applicable general requirements in IEC 60601-2-13. ISO 8835-4:2004 is not applicable to AVDDs intended for use with flammable anaesthetics, as determined by Annex CC, and AVDDs intended for use within anaesthetic breathing systems (e.g. draw-over vaporizers). The requirements of ISO 8835-4:2004 which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.
 

Document History

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


    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

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    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