ISO 9713:2022 神经外科植放物 颅内动脉瘤自闭合剪

标准编号：ISO 9713:2022

中文名称：神经外科植放物 颅内动脉瘤自闭合剪

英文名称：Neurosurgical implants — Self-closing intracranial aneurysm clips

发布日期：2022-01

标准范围

本文件确定了永久性颅内植入用自动闭合动脉瘤夹的特点，并规定了其标记、包装、灭菌、标签和随附文件的要求。此外，还提出了一种闭合力的测量方法。本文件不适用于可塑性夹子，或拟在手术过程中使用并在伤口闭合前移除的夹子（临时夹子）。注:在本文件中，如果没有其他规定，术语“植入物”指的是自动闭合的颅内动脉瘤夹。

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.

标准预览图