CAN/CSA-ISO 27427:24 ✓ Most Recent

CSA Preface 

This is the second edition of 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 ISO 27427 (fourth edition, 2023-07). It supersedes the previous edition, published in 2014 as CAN/CSA-ISO 27427 (adopted ISO 27427:2013). For brevity, this Standard will be referred to as "CSA ISO 27427" throughout. CSA Group acknowledges that the adoption of this Standard was made possible, in part, by the financial support of the governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Ontario, Prince Edward Island, Québec, Saskatchewan, and Yukon, as administered by Canada’s Drug Agency (CDA-AMC). This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Perioperative Safety, under the jurisdiction of the CSA Strategic Steering Committee on Health and Well-being, 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 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 electrical requirements of electrically powered nebulizers. This document does not specify the minimum performance of nebulizing systems. This document does not apply to: a) devices intended for nasal deposition; b) devices intended solely to provide humidification or hydration by providing water in aerosol form. NOTE 1 ISO 80601-2-74 and ISO 20789 cover these devices. c) drug-specific nebulizers or their components (e.g. metered dose inhalers, metered liquid inhalers, dry powder inhalers). NOTE 2 ISO 20072 covers these devices. NOTE 3 See Annex A for rationale.