<p>ISO 8637-1:2017 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in humans.</p>
<p>ISO 8637-1:2017 does not apply to:</p>
<p>- extracorporeal blood circuits;</p>
<p>- plasmafilters;</p>
<p>- haemoperfusion devices;</p>
<p>- vascular access devices;</p>
<p>- blood pumps;</p>
<p>- pressure monitors for the extracorporeal blood circuit;</p>
<p>- air detection devices;</p>
<p>- systems to prepare, maintain or monitor dialysis fluid;</p>
<p>- systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration;</p>
<p>- reprocessing procedures and equipment.</p>
<p>NOTE Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637‑2.</p>
Registration number (WIID)
69843
Scope
<p>ISO 8637-1:2017 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in humans.</p>
<p>ISO 8637-1:2017 does not apply to:</p>
<p>- extracorporeal blood circuits;</p>
<p>- plasmafilters;</p>
<p>- haemoperfusion devices;</p>
<p>- vascular access devices;</p>
<p>- blood pumps;</p>
<p>- pressure monitors for the extracorporeal blood circuit;</p>
<p>- air detection devices;</p>
<p>- systems to prepare, maintain or monitor dialysis fluid;</p>
<p>- systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration;</p>
<p>- reprocessing procedures and equipment.</p>
<p>NOTE Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637‑2.</p>
