标准摘要
[中文适用范围]： 本文件规定了用于永久性颅内植入的自闭合动脉瘤夹的特性，并规定了其标记、包装、灭菌以及标签和随附文件的要求。此外，它还提供了一种测量闭合力的方法。本文件不适用于可塑夹，或用于手术过程中并在伤口闭合前取出的夹（临时夹）。注：在本文件中，除非另有规定，否则术语“植入物”是指自闭合颅内动脉瘤夹。 [外文原描述]： 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.
英文名称Neurosurgical implants — Self-closing intracranial aneurysm clips