ISO/TC 121/SC 6

Project No.ISO 16571:2024
Title<p class="p2"><strong style="mso-bidi-font-weight: normal;"><span lang="EN-GB"><span style="mso-tab-count: 1;"> </span></span></strong><span lang="EN-GB">This document specifies requirements and guidelines for systems and equipment used to evacuate <em style="mso-bidi-font-style: normal;">plume</em> generated by <em style="mso-bidi-font-style: normal;">medical devices</em>.</span></p> <p class="p2"><strong style="mso-bidi-font-weight: normal;"><span lang="EN-GB"><span style="mso-tab-count: 1;"> </span></span></strong><span lang="EN-GB">This document applies to all types of <em style="mso-bidi-font-style: normal;">plume evacuation systems</em> (<em style="mso-bidi-font-style: normal;">PES</em>s), including</span></p> <p class="ListNumber1" style="mso-list: l1 level1 lfo4;"><!-- [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]--><em style="mso-bidi-font-style: normal;"><span lang="EN-GB">portable</span></em><span lang="EN-GB">;</span></p> <p class="ListNumber1" style="mso-list: l1 level1 lfo4;"><!-- [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]--><em style="mso-bidi-font-style: normal;"><span lang="EN-GB">mobile</span></em><span lang="EN-GB">;</span></p> <p class="ListNumber1" style="mso-list: l1 level1 lfo4;"><!-- [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">stationary, including dedicated central pipelines;</span></p> <p class="ListNumber1" style="mso-list: l1 level1 lfo4;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">d)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><em style="mso-bidi-font-style: normal;"><span lang="EN-GB">PES</span></em><span lang="EN-GB">s integrated into other equipment;</span></p> <p class="ListNumber1" style="mso-list: l1 level1 lfo4;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">e)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><em style="mso-bidi-font-style: normal;"><span lang="EN-GB">PES</span></em><span lang="EN-GB">s for endoscopic procedures (e.g., minimally invasive, laparoscopic)</span></p> <p class="p2"><span lang="EN-GB">This document applies to all healthcare facilities where <em style="mso-bidi-font-style: normal;">PES</em>s are used, including, but not limited to</span></p> <p class="ListNumber1" style="mso-list: l2 level1 lfo3;"><!-- [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">surgical facilities;</span></p> <p class="ListNumber1" style="mso-list: l2 level1 lfo3;"><!-- [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">medical offices;</span></p> <p class="ListNumber1" style="mso-list: l2 level1 lfo3;"><!-- [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">cosmetic treatment facilities;</span></p> <p class="ListNumber1" style="mso-list: l2 level1 lfo3;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">d)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><span lang="EN-GB">medical teaching facilities;</span></p> <p class="ListNumber1" style="mso-list: l2 level1 lfo3;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">e)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><span lang="EN-GB">dental clinics;</span></p> <p class="ListNumber1" style="mso-list: l2 level1 lfo3;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">f)<span style="font: 7.0pt 'Times New Roman';">         </span></span></span><!--[endif]--><span lang="EN-GB">veterinary facilities.</span></p> <p class="p2"><span lang="EN-GB">This document provides guidance on the following aspects of <em style="mso-bidi-font-style: normal;">PES</em>s:</span></p> <p class="ListNumber1" style="mso-list: l3 level1 lfo2;"><!-- [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">importance;</span></p> <p class="ListNumber1" style="mso-list: l3 level1 lfo2;"><!-- [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">purchasing;</span></p> <p class="ListNumber1" style="mso-list: l3 level1 lfo2;"><!-- [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">design;</span></p> <p class="ListNumber1" style="mso-list: l3 level1 lfo2;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">d)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><span lang="EN-GB">manufacture;</span></p> <p class="ListNumber1" style="mso-list: l3 level1 lfo2;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">e)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><span lang="EN-GB">documentation;</span></p> <p class="ListNumber1" style="mso-list: l3 level1 lfo2;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">f)<span style="font: 7.0pt 'Times New Roman';">         </span></span></span><!--[endif]--><span lang="EN-GB">function;</span></p> <p class="ListNumber1" style="mso-list: l3 level1 lfo2;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">g)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><span lang="EN-GB">performance;</span></p> <p class="ListNumber1" style="mso-list: l3 level1 lfo2;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">h)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><span lang="EN-GB">installation;</span></p> <p class="ListNumber1" style="mso-list: l3 level1 lfo2;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">i)<span style="font: 7.0pt 'Times New Roman';">         </span></span></span><!--[endif]--><span lang="EN-GB">commissioning;</span></p> <p class="ListNumber1" style="mso-list: l3 level1 lfo2;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">j)<span style="font: 7.0pt 'Times New Roman';">         </span></span></span><!--[endif]--><span lang="EN-GB">testing;</span></p> <p class="ListNumber1" style="mso-list: l3 level1 lfo2;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">k)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><span lang="EN-GB">training;</span></p> <p class="ListNumber1" style="mso-list: l3 level1 lfo2;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">l)<span style="font: 7.0pt 'Times New Roman';">         </span></span></span><!--[endif]--><span lang="EN-GB">use;</span></p> <p class="ListNumber1" style="mso-list: l3 level1 lfo2;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">m)<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">risk assessment;</span></p> <p class="ListNumber1" style="mso-list: l3 level1 lfo2;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">n)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><span lang="EN-GB">servicing;</span></p> <p class="ListNumber1" style="mso-list: l3 level1 lfo2;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">o)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><span lang="EN-GB">maintenance.</span></p> <p class="p2"><span lang="EN-GB">This document does not apply to the following:</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]--><em style="mso-bidi-font-style: normal;"><span lang="EN-GB">anaesthetic gas scavenging systems</span></em><span lang="EN-GB"> (AGSSs) which are covered in ISO 7396-2;</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">medical vacuum systems which are covered in ISO 7396-1;</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">heating, ventilation, and air-conditioning (HVAC) systems;</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;">d)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><span lang="EN-GB">aspects of laser safety other than airborne contamination; and</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;">e)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><span lang="EN-GB">aspects of <em style="mso-bidi-font-style: normal;">electrosurgery</em>, <em style="mso-bidi-font-style: normal;">electrocautery</em>, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.</span></p>
Registration number (WIID)83065
Scope<p class="p2"><strong style="mso-bidi-font-weight: normal;"><span lang="EN-GB"><span style="mso-tab-count: 1;"> </span></span></strong><span lang="EN-GB">This document specifies requirements and guidelines for systems and equipment used to evacuate <em style="mso-bidi-font-style: normal;">plume</em> generated by <em style="mso-bidi-font-style: normal;">medical devices</em>.</span></p> <p class="p2"><strong style="mso-bidi-font-weight: normal;"><span lang="EN-GB"><span style="mso-tab-count: 1;"> </span></span></strong><span lang="EN-GB">This document applies to all types of <em style="mso-bidi-font-style: normal;">plume evacuation systems</em> (<em style="mso-bidi-font-style: normal;">PES</em>s), including</span></p> <p class="ListNumber1" style="mso-list: l1 level1 lfo4;"><!-- [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]--><em style="mso-bidi-font-style: normal;"><span lang="EN-GB">portable</span></em><span lang="EN-GB">;</span></p> <p class="ListNumber1" style="mso-list: l1 level1 lfo4;"><!-- [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]--><em style="mso-bidi-font-style: normal;"><span lang="EN-GB">mobile</span></em><span lang="EN-GB">;</span></p> <p class="ListNumber1" style="mso-list: l1 level1 lfo4;"><!-- [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">stationary, including dedicated central pipelines;</span></p> <p class="ListNumber1" style="mso-list: l1 level1 lfo4;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">d)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><em style="mso-bidi-font-style: normal;"><span lang="EN-GB">PES</span></em><span lang="EN-GB">s integrated into other equipment;</span></p> <p class="ListNumber1" style="mso-list: l1 level1 lfo4;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">e)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><em style="mso-bidi-font-style: normal;"><span lang="EN-GB">PES</span></em><span lang="EN-GB">s for endoscopic procedures (e.g., minimally invasive, laparoscopic)</span></p> <p class="p2"><span lang="EN-GB">This document applies to all healthcare facilities where <em style="mso-bidi-font-style: normal;">PES</em>s are used, including, but not limited to</span></p> <p class="ListNumber1" style="mso-list: l2 level1 lfo3;"><!-- [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">surgical facilities;</span></p> <p class="ListNumber1" style="mso-list: l2 level1 lfo3;"><!-- [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">medical offices;</span></p> <p class="ListNumber1" style="mso-list: l2 level1 lfo3;"><!-- [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">cosmetic treatment facilities;</span></p> <p class="ListNumber1" style="mso-list: l2 level1 lfo3;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">d)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><span lang="EN-GB">medical teaching facilities;</span></p> <p class="ListNumber1" style="mso-list: l2 level1 lfo3;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">e)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><span lang="EN-GB">dental clinics;</span></p> <p class="ListNumber1" style="mso-list: l2 level1 lfo3;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">f)<span style="font: 7.0pt 'Times New Roman';">         </span></span></span><!--[endif]--><span lang="EN-GB">veterinary facilities.</span></p> <p class="p2"><span lang="EN-GB">This document provides guidance on the following aspects of <em style="mso-bidi-font-style: normal;">PES</em>s:</span></p> <p class="ListNumber1" style="mso-list: l3 level1 lfo2;"><!-- [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">importance;</span></p> <p class="ListNumber1" style="mso-list: l3 level1 lfo2;"><!-- [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">purchasing;</span></p> <p class="ListNumber1" style="mso-list: l3 level1 lfo2;"><!-- [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">design;</span></p> <p class="ListNumber1" style="mso-list: l3 level1 lfo2;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">d)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><span lang="EN-GB">manufacture;</span></p> <p class="ListNumber1" style="mso-list: l3 level1 lfo2;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">e)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><span lang="EN-GB">documentation;</span></p> <p class="ListNumber1" style="mso-list: l3 level1 lfo2;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">f)<span style="font: 7.0pt 'Times New Roman';">         </span></span></span><!--[endif]--><span lang="EN-GB">function;</span></p> <p class="ListNumber1" style="mso-list: l3 level1 lfo2;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">g)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><span lang="EN-GB">performance;</span></p> <p class="ListNumber1" style="mso-list: l3 level1 lfo2;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">h)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><span lang="EN-GB">installation;</span></p> <p class="ListNumber1" style="mso-list: l3 level1 lfo2;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">i)<span style="font: 7.0pt 'Times New Roman';">         </span></span></span><!--[endif]--><span lang="EN-GB">commissioning;</span></p> <p class="ListNumber1" style="mso-list: l3 level1 lfo2;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">j)<span style="font: 7.0pt 'Times New Roman';">         </span></span></span><!--[endif]--><span lang="EN-GB">testing;</span></p> <p class="ListNumber1" style="mso-list: l3 level1 lfo2;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">k)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><span lang="EN-GB">training;</span></p> <p class="ListNumber1" style="mso-list: l3 level1 lfo2;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">l)<span style="font: 7.0pt 'Times New Roman';">         </span></span></span><!--[endif]--><span lang="EN-GB">use;</span></p> <p class="ListNumber1" style="mso-list: l3 level1 lfo2;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">m)<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">risk assessment;</span></p> <p class="ListNumber1" style="mso-list: l3 level1 lfo2;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">n)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><span lang="EN-GB">servicing;</span></p> <p class="ListNumber1" style="mso-list: l3 level1 lfo2;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria;"><span style="mso-list: Ignore;">o)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><span lang="EN-GB">maintenance.</span></p> <p class="p2"><span lang="EN-GB">This document does not apply to the following:</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]--><em style="mso-bidi-font-style: normal;"><span lang="EN-GB">anaesthetic gas scavenging systems</span></em><span lang="EN-GB"> (AGSSs) which are covered in ISO 7396-2;</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">medical vacuum systems which are covered in ISO 7396-1;</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">heating, ventilation, and air-conditioning (HVAC) systems;</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;">d)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><span lang="EN-GB">aspects of laser safety other than airborne contamination; and</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;">e)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><span lang="EN-GB">aspects of <em style="mso-bidi-font-style: normal;">electrosurgery</em>, <em style="mso-bidi-font-style: normal;">electrocautery</em>, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.</span></p>
StatusStandarts spēkā
ICS group11.040.10