ISO/TC 150/SC 2

Project No.ISO 7199:2024
Title<p class="MsoBodyText"><span lang="EN-GB">This document specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for the supply of oxygen to, and the removal of carbon dioxide from, human blood, during cardiopulmonary bypass (CPB) for up to 6 h, extracorporeal lung assist [ECLA with veno-venous (VV), veno-arterial (VA) or veno-arterial-venous (VAV) cannulation strategies], cardiopulmonary support (CPS), extracorporeal life support (ECLS with VA cannulation strategy), extracorporeal carbon dioxide removal (ECCO<sub>2</sub>R), and other extracorporeal circulation techniques requiring blood-gas exchange.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document also applies to heat exchangers and arterial filters that are integral parts of the oxygenator.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document also applies to external equipment unique to the use of the oxygenator.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document does not apply to</span></p> <p class="ListContinue1" 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;">—<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">implanted oxygenators,</span></p> <p class="ListContinue1" 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;">—<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">liquid oxygenators,</span></p> <p class="ListContinue1" 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;">—<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">extracorporeal circuits (blood tubing),</span></p> <p class="ListContinue1" 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;">—<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">separate heat exchangers,</span></p> <p class="ListContinue1" 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;">—<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">separate ancillary devices, and</span></p> <p class="ListContinue1" 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;">—<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">separate arterial line filters.</span></p>
Registration number (WIID)83184
Scope<p class="MsoBodyText"><span lang="EN-GB">This document specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for the supply of oxygen to, and the removal of carbon dioxide from, human blood, during cardiopulmonary bypass (CPB) for up to 6 h, extracorporeal lung assist [ECLA with veno-venous (VV), veno-arterial (VA) or veno-arterial-venous (VAV) cannulation strategies], cardiopulmonary support (CPS), extracorporeal life support (ECLS with VA cannulation strategy), extracorporeal carbon dioxide removal (ECCO<sub>2</sub>R), and other extracorporeal circulation techniques requiring blood-gas exchange.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document also applies to heat exchangers and arterial filters that are integral parts of the oxygenator.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document also applies to external equipment unique to the use of the oxygenator.</span></p> <p class="MsoBodyText"><span lang="EN-GB">This document does not apply to</span></p> <p class="ListContinue1" 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;">—<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">implanted oxygenators,</span></p> <p class="ListContinue1" 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;">—<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">liquid oxygenators,</span></p> <p class="ListContinue1" 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;">—<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">extracorporeal circuits (blood tubing),</span></p> <p class="ListContinue1" 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;">—<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">separate heat exchangers,</span></p> <p class="ListContinue1" 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;">—<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">separate ancillary devices, and</span></p> <p class="ListContinue1" 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;">—<span style="font: 7.0pt 'Times New Roman';">     </span></span></span><!--[endif]--><span lang="EN-GB">separate arterial line filters.</span></p>
StatusStandarts spēkā
ICS group11.040.40