scope:

This document establishes guidance and procedures for radiographic examination of implants for surgery manufactured by casting of metallic materials and related weldment. The guidance and procedures established in this document include the computed and digital method examination. NOTE 1 - The requirements in this document are intended to establish controls for the quality of the radiographic image of cast metallic surgical implants and related weldments. NOTE 2 - The requirements established in this document can be used for inspections conducted under responsibility of an implant purchaser. NOTE 3 - 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".