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.
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).
NOTE In this document when not otherwise established, the term “implant” refers to the self-closing intracranial aneurysm clips.
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