ISO 9584:2023 PDF
Implants for surgery — Non-destructive testing — Radiographic examination of cast metallic surgical implants
Implants for surgery — Non-destructive testing — Radiographic examination of cast metallic surgical implants
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 7
- Дата публикации:
- 17 октября 2023 г.
- Издание:
- ISO IS 9584 edition 2 version 1
- ICS:
- 11.040.40
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”.
Abstract
Overview
ISO 9584:2023 - "Implants for surgery - Non‑destructive testing - Radiographic examination of cast metallic surgical implants" defines a film‑based radiographic method to detect and evaluate internal imperfections (porosity, inclusions, shrinkage and related weldments) in cast metallic surgical implants. The standard updates radiographic approaches for cobalt, iron and titanium alloys and adds requirements for image quality indicators, acceptance limits and personnel certification.
Key topics and requirements
- Scope and method: Applies to film‑based radiographic examination of cast metallic surgical implants and related weldments. Radiographic methods shall follow ISO 5579 or ASTM F629.
- Image quality: Image quality must conform to ISO 19232‑3. Minimum image quality levels: level 2 for X‑ray energies
Технические детали
- Технический комитет
- ISO/TC 150/SC 1 - Materials
- SKU
- ISO 9584:2023
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