Project No.ISO 27427:2010
Title<p>ISO 27427:2010 specifies requirements for the safety, performance and testing for general purpose <b>nebulizing systems</b> intended for <b>continuous</b> or <b>breath-actuated</b> delivery of liquids, in an <b>aerosol</b> form, to humans through the respiratory system.</p> <p>ISO 27427:2010 includes <b>gas-powered nebulizers</b> which can be powered by, for example, compressors, pipeline systems, cylinders, etc., and <b>electrically-powered nebulizers</b> [e.g. spinning disc, ultrasonic, vibrating mesh (active and passive) and capillary devices] or <b>manually-powered nebulizers</b>.</p> <p>ISO 27427:2010 does not apply to devices intended for nasal deposition.</p> <p>ISO 27427:2010 does not apply to devices intended solely to provide humidification or hydration by providing water in <b>aerosol</b> form.</p> <p>ISO 27427:2010 does not apply to drug-specific <b>nebulizers</b> (e.g. metered dose inhalers, metered liquid inhalers, dry powder inhalers and their components).</p>
Registration number (WIID)55471
Scope<p>ISO 27427:2010 specifies requirements for the safety, performance and testing for general purpose <b>nebulizing systems</b> intended for <b>continuous</b> or <b>breath-actuated</b> delivery of liquids, in an <b>aerosol</b> form, to humans through the respiratory system.</p> <p>ISO 27427:2010 includes <b>gas-powered nebulizers</b> which can be powered by, for example, compressors, pipeline systems, cylinders, etc., and <b>electrically-powered nebulizers</b> [e.g. spinning disc, ultrasonic, vibrating mesh (active and passive) and capillary devices] or <b>manually-powered nebulizers</b>.</p> <p>ISO 27427:2010 does not apply to devices intended for nasal deposition.</p> <p>ISO 27427:2010 does not apply to devices intended solely to provide humidification or hydration by providing water in <b>aerosol</b> form.</p> <p>ISO 27427:2010 does not apply to drug-specific <b>nebulizers</b> (e.g. metered dose inhalers, metered liquid inhalers, dry powder inhalers and their components).</p>
StatusAtcelts
ICS group11.040.10