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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.040 Medical equipment>11.040.10 Anaesthetic, respiratory and reanimation equipment>21/30396844 DC BS EN ISO 27427. Anaesthetic and respiratory equipment. Nebulizing systems and components
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21/30396844 DC BS EN ISO 27427. Anaesthetic and respiratory equipment. Nebulizing systems and components

21/30396844 DC

BS EN ISO 27427. Anaesthetic and respiratory equipment. Nebulizing systems and components

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Standard number:21/30396844 DC
Pages:49
Released:2021-03-19
Status:Draft for Comment
DESCRIPTION

21/30396844 DC


This standard 21/30396844 DC BS EN ISO 27427. Anaesthetic and respiratory equipment. Nebulizing systems and components is classified in these ICS categories:
  • 11.040.10 Anaesthetic, respiratory and reanimation equipment

*This document specifies requirements for the safety and performance testing of general-purpose nebulizing systems intended for continuous or breath-actuated delivery of liquids, in aerosol form, to humans through the respiratory system.

This document includes gas-powered nebulizers which can be powered by, e.g., compressors, pipeline systems, cylinders, etc., and electrically powered nebulizers [e.g., spinning disc, ultrasonic, vibrating mesh (active and passive), and capillary devices] or manually powered nebulizers.

This document does not specify the minimum performance of nebulizing systems.

*This document does not apply to:

  1. devices intended for nasal deposition;

  2. devices intended solely to provide humidification or hydration by providing water in aerosol form.

NOTE

ISO 80601-2-74 [3] and ISO 20789[[4]] cover these devices.

*This document does not apply to drug-specific nebulizers or their components (e.g., metered dose inhalers, metered liquid inhalers, dry powder inhalers).