ISO/TC 150/SC 2/WG 5

Project No.ISO 8637-2:2024
Title<p class="MsoBodyText"><span lang="EN-GB">This document specifies requirements for disposable extracorporeal blood and fluid circuits and accessories used in combination with haemodialysis equipment intended for extracorporeal blood treatment therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration.</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">haemodialysers, haemodiafilters or haemofilters;</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">plasmafilters;</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">haemoperfusion devices;</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">vascular access devices.</span></p> <p class="Note"><span lang="EN-GB">NOTE 1<span style="mso-tab-count: 1;">        </span>Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1.</span></p> <p class="Note"><span lang="EN-GB">NOTE 2<span style="mso-tab-count: 1;">        </span>Requirements for plasmafilters are specified in ISO 8637-3.</span></p>
Registration number (WIID)80229
Scope<p class="MsoBodyText"><span lang="EN-GB">This document specifies requirements for disposable extracorporeal blood and fluid circuits and accessories used in combination with haemodialysis equipment intended for extracorporeal blood treatment therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration.</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">haemodialysers, haemodiafilters or haemofilters;</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">plasmafilters;</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">haemoperfusion devices;</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">vascular access devices.</span></p> <p class="Note"><span lang="EN-GB">NOTE 1<span style="mso-tab-count: 1;">        </span>Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1.</span></p> <p class="Note"><span lang="EN-GB">NOTE 2<span style="mso-tab-count: 1;">        </span>Requirements for plasmafilters are specified in ISO 8637-3.</span></p>
StatusStandarts spēkā
ICS group11.040.40