Тезис

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.


Общая информация 

  • Текущий статус
     :  Withdrawn
    Дата публикации
     : 2004-06
  • Версия
     : 1
  • Технический комитет
     : ISO/TC 121/SC 1 Breathing attachments and anaesthetic machines
  • ICS
     :
    11.040.10 Anaesthetic, respiratory and reanimation equipment

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  5. ISO/TC 121/SC 1
  6. ISO 8835-4:2004