Тезис

For ISO 17510-1:2002, the scope given in clause 1 of EN 60601-1:1990 + A1:1993 and A12:1993 applies with the following addition.

ISO 17510-1:2002 specifies requirements for devices intended for sleep apnoea breathing therapy for domiciliary use and for use in healthcare institutions.

ISO 17510-1:2002 is not applicable to jet and very high frequency ventilation and oscillation.

ISO 17510-1:2002 is not applicable to devices covered by the scope of the EN 794 series.

ISO 17510-1:2002 is not applicable to external body ventilators as defined in ISO 4135.

NOTE Masks and application accessories are addressed in ISO 17510-2.


Общая информация 

  • Текущий статус
     : Отозвано
    Дата публикации
     : 2002-02
  • Версия
     : 1
  • Технический комитет
     : ISO/TC 121/SC 3 Respiratory devices and related equipment used for patient care
  • ICS
     :
    11.040.10 Anaesthetic, respiratory and reanimation equipment

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  3. Каталог стандартов
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  7. 11.040.10
  8. ISO 17510-1:2002