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prEN ISO 9713

Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO/DIS 9713:2021)

General information
Draft
Base Documents
ISO/DIS 9713; prEN ISO 9713
Directives or regulations
None
Standard history
Status
Date
Type
Name
03.12.2009
Main
This document describes 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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Standard monitoring