<p>This document specifies requirements and acceptance criteria (including test methods) for safety related parameters for plasmafilters. Only those requirements that are specific to plasmafilters have been included.</p>
<p>It specifies requirements for sterile, single-use plasmafilters, intended for use on humans.</p>
<p>This document does not cover matters related to toxicity. Such issues are covered in relevant parts of ISO 10993.</p>
<p>It does not apply to the extracorporeal circuits that can be used for plasmapheresis vascular access devices, oxygenators or active medical devices. This document does not address the replacement fluid.</p>
Registration number (WIID)
69845
Scope
<p>This document specifies requirements and acceptance criteria (including test methods) for safety related parameters for plasmafilters. Only those requirements that are specific to plasmafilters have been included.</p>
<p>It specifies requirements for sterile, single-use plasmafilters, intended for use on humans.</p>
<p>This document does not cover matters related to toxicity. Such issues are covered in relevant parts of ISO 10993.</p>
<p>It does not apply to the extracorporeal circuits that can be used for plasmapheresis vascular access devices, oxygenators or active medical devices. This document does not address the replacement fluid.</p>
