ISO/TC 121/SC 6

Projekta Nr.ISO 16571:2024
Nosaukums<p class="p2"><span lang="FR" style="mso-ansi-language: FR;">Le présent document spécifie les exigences et les lignes directrices applicables aux systèmes et équipements utilisés pour évacuer les <em style="mso-bidi-font-style: normal;">fumées chirurgicales</em> générées par l’utilisation de <em style="mso-bidi-font-style: normal;">dispositifs médicaux</em>.</span></p> <p class="p2"><strong style="mso-bidi-font-weight: normal;"><span lang="FR" style="mso-ansi-language: FR;"><span style="mso-tab-count: 1;"> </span></span></strong><span lang="FR" style="mso-ansi-language: FR;">Le présent document s’applique à tous les types de <em style="mso-bidi-font-style: normal;">systèmes d’évacuation des fumées chirurgicales</em> (<em style="mso-bidi-font-style: normal;">SEFC</em>), notamment:</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">s;</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">s;</span></p> <p class="ListNumber1" style="mso-list: l1 level1 lfo4;"><!-- [if !supportLists]--><span lang="FR" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria; mso-ansi-language: FR;"><span style="mso-list: Ignore;">c)<span style="font: 7.0pt 'Times New Roman';">        </span></span></span><!--[endif]--><span lang="FR" style="mso-ansi-language: FR;">fixes, y compris canalisations centrales dédiées;</span></p> <p class="ListNumber1" style="mso-list: l1 level1 lfo4;"><!-- [if !supportLists]--><span lang="FR" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria; mso-ansi-language: FR;"><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="FR" style="mso-ansi-language: FR;">SEFC</span></em><span lang="FR" style="mso-ansi-language: FR;"> intégrés dans d’autres équipements;</span></p> <p class="ListNumber1" style="mso-list: l1 level1 lfo4;"><!-- [if !supportLists]--><span lang="FR" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria; mso-ansi-language: FR;"><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="FR" style="mso-ansi-language: FR;">SEFC</span></em><span lang="FR" style="mso-ansi-language: FR;"> pour procédures endoscopiques (par exemple, minimalement invasives, laparoscopiques).</span></p> <p class="p2"><span lang="FR" style="mso-ansi-language: FR;">Le présent document s’applique à tous les établissements de soins dans lesquels des <em style="mso-bidi-font-style: normal;">SEFC</em> sont utilisés, y compris, entre autres:</span></p> <p class="ListNumber1" style="mso-list: l0 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">établissements chirurgicaux;</span></p> <p class="ListNumber1" style="mso-list: l0 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">cabinets médicaux;</span></p> <p class="ListNumber1" style="mso-list: l0 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">établissements de soins cosmétiques;</span></p> <p class="ListNumber1" style="mso-list: l0 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">établissements d’enseignement médical;</span></p> <p class="ListNumber1" style="mso-list: l0 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">cliniques dentaires;</span></p> <p class="ListNumber1" style="mso-list: l0 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">cliniques vétérinaires.</span></p> <p class="p2"><span lang="FR" style="mso-ansi-language: FR;">Le présent document fournit des recommandations sur les aspects suivants des <em style="mso-bidi-font-style: normal;">SEFC</em>:</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">achat;</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">conception;</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">fabrication;</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">fonction;</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">mise en service;</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">essais;</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">formation;</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">utilisation;</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">évaluation des risques;</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">entretien;</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="FR" style="mso-ansi-language: FR;">Le présent document ne s’applique pas aux systèmes suivants:</span></p> <p class="ListNumber1" style="mso-list: l2 level1 lfo1;"><!-- [if !supportLists]--><span lang="FR" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria; mso-ansi-language: FR;"><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="FR" style="mso-ansi-language: FR;">systèmes d’évacuation des gaz anesthésiques</span></em><span lang="FR" style="mso-ansi-language: FR;"> (SEGA) abordés dans l’ISO 7396-2;</span></p> <p class="ListNumber1" style="mso-list: l2 level1 lfo1;"><!-- [if !supportLists]--><span lang="FR" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria; mso-ansi-language: FR;"><span style="mso-list: Ignore;">b)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><span lang="FR" style="mso-ansi-language: FR;">systèmes de vide médical abordés dans l’ISO 7396-1;</span></p> <p class="ListNumber1" style="mso-list: l2 level1 lfo1;"><!-- [if !supportLists]--><span lang="FR" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria; mso-ansi-language: FR;"><span style="mso-list: Ignore;">c)<span style="font: 7.0pt 'Times New Roman';">        </span></span></span><!--[endif]--><span lang="FR" style="mso-ansi-language: FR;">systèmes de chauffage, ventilation et climatisation (CVC);</span></p> <p class="ListNumber1" style="mso-list: l2 level1 lfo1;"><!-- [if !supportLists]--><span lang="FR" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria; mso-ansi-language: FR;"><span style="mso-list: Ignore;">d)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><span lang="FR" style="mso-ansi-language: FR;">aspects liés à la sécurité des lasers, autres que la contamination atmosphérique; et</span></p> <p class="ListNumber1" style="mso-list: l2 level1 lfo1;"><!-- [if !supportLists]--><span lang="FR" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria; mso-ansi-language: FR;"><span style="mso-list: Ignore;">e)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><span lang="FR" style="mso-ansi-language: FR;">aspects liés à l’<em style="mso-bidi-font-style: normal;">électrochirurgie, l’électrocautérisation</em> et les outils chirurgicaux mécaniques, autres que la contamination atmosphérique produite par ces équipements découlant de l’interaction avec les tissus ou les matériaux.</span></p>
Reģistrācijas numurs (WIID)83065
Darbības sfēra<p class="p2"><span lang="FR" style="mso-ansi-language: FR;">Le présent document spécifie les exigences et les lignes directrices applicables aux systèmes et équipements utilisés pour évacuer les <em style="mso-bidi-font-style: normal;">fumées chirurgicales</em> générées par l’utilisation de <em style="mso-bidi-font-style: normal;">dispositifs médicaux</em>.</span></p> <p class="p2"><strong style="mso-bidi-font-weight: normal;"><span lang="FR" style="mso-ansi-language: FR;"><span style="mso-tab-count: 1;"> </span></span></strong><span lang="FR" style="mso-ansi-language: FR;">Le présent document s’applique à tous les types de <em style="mso-bidi-font-style: normal;">systèmes d’évacuation des fumées chirurgicales</em> (<em style="mso-bidi-font-style: normal;">SEFC</em>), notamment:</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">s;</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">s;</span></p> <p class="ListNumber1" style="mso-list: l1 level1 lfo4;"><!-- [if !supportLists]--><span lang="FR" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria; mso-ansi-language: FR;"><span style="mso-list: Ignore;">c)<span style="font: 7.0pt 'Times New Roman';">        </span></span></span><!--[endif]--><span lang="FR" style="mso-ansi-language: FR;">fixes, y compris canalisations centrales dédiées;</span></p> <p class="ListNumber1" style="mso-list: l1 level1 lfo4;"><!-- [if !supportLists]--><span lang="FR" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria; mso-ansi-language: FR;"><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="FR" style="mso-ansi-language: FR;">SEFC</span></em><span lang="FR" style="mso-ansi-language: FR;"> intégrés dans d’autres équipements;</span></p> <p class="ListNumber1" style="mso-list: l1 level1 lfo4;"><!-- [if !supportLists]--><span lang="FR" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria; mso-ansi-language: FR;"><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="FR" style="mso-ansi-language: FR;">SEFC</span></em><span lang="FR" style="mso-ansi-language: FR;"> pour procédures endoscopiques (par exemple, minimalement invasives, laparoscopiques).</span></p> <p class="p2"><span lang="FR" style="mso-ansi-language: FR;">Le présent document s’applique à tous les établissements de soins dans lesquels des <em style="mso-bidi-font-style: normal;">SEFC</em> sont utilisés, y compris, entre autres:</span></p> <p class="ListNumber1" style="mso-list: l0 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">établissements chirurgicaux;</span></p> <p class="ListNumber1" style="mso-list: l0 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">cabinets médicaux;</span></p> <p class="ListNumber1" style="mso-list: l0 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">établissements de soins cosmétiques;</span></p> <p class="ListNumber1" style="mso-list: l0 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">établissements d’enseignement médical;</span></p> <p class="ListNumber1" style="mso-list: l0 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">cliniques dentaires;</span></p> <p class="ListNumber1" style="mso-list: l0 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">cliniques vétérinaires.</span></p> <p class="p2"><span lang="FR" style="mso-ansi-language: FR;">Le présent document fournit des recommandations sur les aspects suivants des <em style="mso-bidi-font-style: normal;">SEFC</em>:</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">achat;</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">conception;</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">fabrication;</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">fonction;</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">mise en service;</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">essais;</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">formation;</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">utilisation;</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">évaluation des risques;</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">entretien;</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="FR" style="mso-ansi-language: FR;">Le présent document ne s’applique pas aux systèmes suivants:</span></p> <p class="ListNumber1" style="mso-list: l2 level1 lfo1;"><!-- [if !supportLists]--><span lang="FR" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria; mso-ansi-language: FR;"><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="FR" style="mso-ansi-language: FR;">systèmes d’évacuation des gaz anesthésiques</span></em><span lang="FR" style="mso-ansi-language: FR;"> (SEGA) abordés dans l’ISO 7396-2;</span></p> <p class="ListNumber1" style="mso-list: l2 level1 lfo1;"><!-- [if !supportLists]--><span lang="FR" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria; mso-ansi-language: FR;"><span style="mso-list: Ignore;">b)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><span lang="FR" style="mso-ansi-language: FR;">systèmes de vide médical abordés dans l’ISO 7396-1;</span></p> <p class="ListNumber1" style="mso-list: l2 level1 lfo1;"><!-- [if !supportLists]--><span lang="FR" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria; mso-ansi-language: FR;"><span style="mso-list: Ignore;">c)<span style="font: 7.0pt 'Times New Roman';">        </span></span></span><!--[endif]--><span lang="FR" style="mso-ansi-language: FR;">systèmes de chauffage, ventilation et climatisation (CVC);</span></p> <p class="ListNumber1" style="mso-list: l2 level1 lfo1;"><!-- [if !supportLists]--><span lang="FR" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria; mso-ansi-language: FR;"><span style="mso-list: Ignore;">d)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><span lang="FR" style="mso-ansi-language: FR;">aspects liés à la sécurité des lasers, autres que la contamination atmosphérique; et</span></p> <p class="ListNumber1" style="mso-list: l2 level1 lfo1;"><!-- [if !supportLists]--><span lang="FR" style="mso-fareast-font-family: Cambria; mso-bidi-font-family: Cambria; mso-ansi-language: FR;"><span style="mso-list: Ignore;">e)<span style="font: 7.0pt 'Times New Roman';">       </span></span></span><!--[endif]--><span lang="FR" style="mso-ansi-language: FR;">aspects liés à l’<em style="mso-bidi-font-style: normal;">électrochirurgie, l’électrocautérisation</em> et les outils chirurgicaux mécaniques, autres que la contamination atmosphérique produite par ces équipements découlant de l’interaction avec les tissus ou les matériaux.</span></p>
StatussStandarts spēkā
ICS grupa11.040.10