标准摘要
[中文适用范围]： 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胶片的方法。附录 A 给出了铸造金属外科植入物内部缺陷的可接受限度建议。注：在本文件中，如无其他规定，术语“制造商”指“植入物制造商”，术语“产品”指“外科用金属铸造植入物”或“外科用金属铸造植入物的组件”。 [外文原描述]： 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”.
英文名称Implants for surgery — Non-destructive testing — Radiographic examination of cast metallic surgical implants