BSI 21/30396844 DC:2021 Edition

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

Published By	Publication Date	Number of Pages
BSI	2021	49

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Categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment, BSI

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Description

*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:

devices intended for nasal deposition;
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).

Additional information

Status	Definitive
Pages	49
Publication Date	2021-03-19
Standard Number	21/30396844 DC
Title	BS EN ISO 27427. Anaesthetic and respiratory equipment. Nebulizing systems and components
Identical National Standard Of	ISO/DIS 27427
Descriptors	Risk assessment, Electrical insulation, Clearance distances, Heating tests, Leakage currents, Hazards, Electrical equipment, Electrical testing, Symbols, Testing conditions, Environmental testing, Penetration tests, Impact testing, Electronic equipment and components, Electrical safety, Environment (working), Performance, Drop tests, Leakage paths, Protected electrical equipment, Radiation hazards, Instructions for use, Electrical medical equipment, Flexible conductors, Marking, Classification systems, Safety measures, Control systems, Earthing, Medical equipment, Circuits, Fire risks, Type testing
Publisher	BSI
Committee	CH/121/5
ICS Codes	11.040.10 - Anaesthetic, respiratory and reanimation equipment

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BSI 21/30396844 DC:2021 Edition

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