CSA Preface
This is the first edition of CAN/CSA-ISO 27427, Anaesthetic and respiratory equipment - Nebulizing systems and components, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 27427 (third edition, 2013-12-15).
For brevity, this Standard will be referred to as “CAN/CSA-ISO 27427” throughout.
This Standard was reviewed for Canadian adoption by the Standards Mirror Committee to ISO/TC 121, under the jurisdiction of the CSA Technical Committee on Perioperative Safety and the CSA Strategic Steering Committee on Health Care Technology and Systems, and has been formally approved by the Technical Committee.
This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.
Scope
*This International Standard 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 International Standard 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 International Standard does not specify the minimum performance of nebulizing systems.
*This International Standard does not apply to devices intended for nasal deposition.
This International Standard does not apply to devices intended solely to provide humidification or hydration by providing water in aerosol form.
NOTE ISO 8185 covers this.
*This International Standard does not apply to drug-specific nebulizers or their components (e.g., metered dose inhalers, metered liquid inhalers, dry powder inhalers).