ISO 9584:2023 外科植入物 无损检验 铸造金属外科植入物射线照相检验

标准编号:ISO 9584:2023

中文名称:外科植入物 无损检验 铸造金属外科植入物射线照相检验

英文名称:Implants for surgery — Non-destructive testing — Radiographic examination of cast metallic surgical implants

发布日期:2023-10

标准范围

本文件建立了一种检测和评估铸造金属外科植入物和相关焊接件内部缺陷的方法。本文件中建立的程序适用于基于薄膜的方法。关于铸造金属外科植入物内部缺陷验收限度的建议见附录?A.笔记?在本文中,除非另有说明,术语“制造商”是指“植入物制造商”,并且术语“产品”是指“用于外科手术的金属铸造植入物”或“用于外科手术的金属铸造植入物的部件”。

This document establishes a method for detecting and evaluating internal imperfections of cast metallic surgical implants and related weldments.

The procedures established in this document apply to film-based methods.

The recommendations on the acceptance limits for internal imperfections in cast metallic surgical implants are given in Annex A.NOTE   In this document, when not otherwise specified, the term “manufacturer” refers to the “implant manufacturer”, and the term “product” refers to the “metallic cast implant for surgery” or to the “component of metallic cast implant for surgery”.

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