ISO/TC 121/SC 2

Project No.ISO 27427:2023
Title<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>
Registration number (WIID)78542
Scope<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>
StatusStandarts spēkā
ICS group11.040.10