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<p>This document establishes the characteristics of self-closing aneurysm clips intended for permanent intracranial implantation and specifies requirements for their marking, packaging, sterilization and for labelling and accompanying documentation. In addition, it gives a method for the measurement of closing force.</p>
<p>This document is not applicable to malleable clips, or clips intended to be used during the course of surgery and removed before wound closure (temporary clips).</p>
<p>NOTE In this document when not otherwise established, the term “implant” refers to the self-closing intracranial aneurysm clips.</p>
Reģistrācijas numurs (WIID)
75217
Darbības sfēra
<p>This document establishes the characteristics of self-closing aneurysm clips intended for permanent intracranial implantation and specifies requirements for their marking, packaging, sterilization and for labelling and accompanying documentation. In addition, it gives a method for the measurement of closing force.</p>
<p>This document is not applicable to malleable clips, or clips intended to be used during the course of surgery and removed before wound closure (temporary clips).</p>
<p>NOTE In this document when not otherwise established, the term “implant” refers to the self-closing intracranial aneurysm clips.</p>
