<p class="MsoBodyText"><span lang="EN-GB">This document specifies the minimum chemical and microbiological quality requirements for dialysis fluids used in haemodialysis and related therapies.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document applies 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">dialysis fluids used for haemodialysis and haemodiafiltration,</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">substitution fluid produced online for haemodiafiltration and haemofiltration based on dialysis fluid</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">the water and concentrates used to prepare dialysis fluid or the equipment to produce dialysis fluid</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">sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid,</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">systems for continuous renal replacement therapy that use pre-packaged solutions, 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">systems and solutions for peritoneal dialysis.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">The delivery and monitoring of the dialysis fluid composition and its permitted deviation from set points is governed by protective systems defined in IEC 60601-2-16.</span></p>
Registration number (WIID)
84372
Scope
<p class="MsoBodyText"><span lang="EN-GB">This document specifies the minimum chemical and microbiological quality requirements for dialysis fluids used in haemodialysis and related therapies.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">This document applies 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">dialysis fluids used for haemodialysis and haemodiafiltration,</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">substitution fluid produced online for haemodiafiltration and haemofiltration based on dialysis fluid</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">the water and concentrates used to prepare dialysis fluid or the equipment to produce dialysis fluid</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">sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid,</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">systems for continuous renal replacement therapy that use pre-packaged solutions, 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">systems and solutions for peritoneal dialysis.</span></p>
<p class="MsoBodyText"><span lang="EN-GB">The delivery and monitoring of the dialysis fluid composition and its permitted deviation from set points is governed by protective systems defined in IEC 60601-2-16.</span></p>
