NF EN ISO 27427

<p>ISO 27427:2013 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.</p> <p>ISO 27427:2013 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.</p>

Le présent document spécifie les exigences relatives aux systèmes de nébulisation utilisés pour l'administration des médicaments sous forme d'un aérosol via le système pulmonaire. Il est basé sur la norme NF EN 60601-1, de février 1991.

<p class="MsoBodyText"><span lang="EN-GB">This document specifies requirements for the safety and performance testing of general-purpose <em style="mso-bidi-font-style: normal;">nebulizing systems</em> intended for continuous or breath-actuated delivery of liquids, in <em style="mso-bidi-font-style: normal;">aerosol</em> form, to humans through the respiratory system.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document includes <em style="mso-bidi-font-style: normal;">gas-powered nebulizers</em> (which can be powered by, e.g., compressors, pipeline systems, cylinders, etc.) and <em style="mso-bidi-font-style: normal;">electrically powered nebulizers</em> [e.g. spinning disc, ultrasonic, vibrating mesh (active and passive), and capillary devices] or <em style="mso-bidi-font-style: normal;">manually powered nebulizers</em>. This document does not specify the electrical requirements of <em style="mso-bidi-font-style: normal;">electrically powered nebulizers</em>.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document does not specify the minimum performance of <em style="mso-bidi-font-style: normal;">nebulizing systems</em>.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document does not apply to:</span></p> <p class="ListNumber1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">a)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><span lang="EN-GB">devices intended for nasal deposition;</span></p> <p class="ListNumber1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">b)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><span lang="EN-GB">devices intended solely to provide humidification or hydration by providing water in <em style="mso-bidi-font-style: normal;">aerosol</em> form.</span></p> <p class="Noteindent"><span lang="EN-GB">NOTE 1<span style="mso-tab-count: 1;">        </span>ISO 80601-2-74 and ISO 20789 cover these devices.</span></p> <p class="ListNumber1" style="mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">c)<span style="font: 7.0pt 'Times New Roman';">        </span></span></span><!--[endif]--><span lang="EN-GB">drug-specific <em style="mso-bidi-font-style: normal;">nebulizers</em> or their components (e.g. metered dose inhalers, metered liquid inhalers, dry powder inhalers).</span></p> <p class="Note"><span lang="EN-GB">NOTE 2<span style="mso-tab-count: 1;">        </span>ISO 20072 covers these devices.</span></p> <p class="Note"><span lang="EN-GB">NOTE 3<span style="mso-tab-count: 1;">        </span>See Annex A for rationale.</span></p>