ISO 27427:2010
Anaesthetic and respiratory equipment — Nebulizing systems and components
ISO 27427:2010 specifies requirements for the safety, performance and testing for general purpose nebulizing systems intended for continuous or breath-actuated delivery of liquids, in an aerosol form, to humans through the respiratory system.
ISO 27427:2010 includes gas-powered nebulizers which can be powered by, for example, 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.
ISO 27427:2010 does not apply to devices intended for nasal deposition.
ISO 27427:2010 does not apply to devices intended solely to provide humidification or hydration by providing water in aerosol form.
ISO 27427:2010 does not apply to drug-specific nebulizers (e.g. metered dose inhalers, metered liquid inhalers, dry powder inhalers and their components).
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*Scope
Normative references
Terms and definitions
General requirements and requirements for test
Risk management
General
Clinical evaluation
*Test methods and alternatives
Test methods for aerosol output, aerosol output rate and par
Alternative test methods
Electrical safety
Mechanical safety
Pneumatic safety
Protection against inadvertent adjustments
Protection against infection
Usability
Marking and instructions for use
Marking
General
Marking of devices, labels and packaging
Marking of controls and instruments
Symbols
Instructions for use
*General
Disclosures
Materials compatibility
Driving gas supply
Cleaning, disinfection and sterilization
Dismantling and reassembling
Monitoring, alarm and protection devices
Electromagnetic compatibility
Device disposal
Parts not integral to the nebulizing system
Construction requirements
Materials
Connectors
Driving gas inlet connectors
Nebulizer breathing system connectors
Nebulizer outlet connector
Flow-direction-sensitive connectors
Small-bore nebulizer connector
Rotary controls
Cleaning, sterilization and disinfection
Biocompatibility
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*Scope
Normative references
Terms and definitions
General requirements and requirements for test
Risk management
General
Clinical evaluation
*Test methods and alternatives
Test methods for aerosol output, aerosol output rate and par
Alternative test methods
Electrical safety
Mechanical safety
Pneumatic safety
Protection against inadvertent adjustments
Protection against infection
Usability
Marking and instructions for use
Marking
General
Marking of devices, labels and packaging
Marking of controls and instruments
Symbols
Instructions for use
*General
Disclosures
Materials compatibility
Driving gas supply
Cleaning, disinfection and sterilization
Dismantling and reassembling
Monitoring, alarm and protection devices
Electromagnetic compatibility
Device disposal
Parts not integral to the nebulizing system
Construction requirements
Materials
Connectors
Driving gas inlet connectors
Nebulizer breathing system connectors
Nebulizer outlet connector
Flow-direction-sensitive connectors
Small-bore nebulizer connector
Rotary controls
Cleaning, sterilization and disinfection
Biocompatibility