ISO 9584:2023

Implants for surgery - Non-destructive testing - Radiographic examination of cast metallic surgical implants

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”.

Implants chirurgicaux — Essais non destructifs — Contrôle radiographique des implants chirurgicaux métalliques moulés

General Information

• Status: Published
• Publication Date: 16-Oct-2023
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: ISO/TC 150/SC 1 - Materials
• Drafting Committee: ISO/TC 150/SC 1/WG 4 - Metals
• Current Stage: 6060 - International Standard published
• Start Date: 17-Oct-2023
• Due Date: 14-Aug-2023
• Completion Date: 17-Oct-2023

Relations

• Revises: ISO 9584:1993 - Implants for surgery - Non-destructive testing - Radiographic examination of cast metallic surgical implants
• Effective Date: 23-Apr-2020

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 < 500 kV and level 4 for energies ≥ 500 kV.
• Image quality indicators (IQI): An IQI must be included in every radiograph, represent the area of interest, and be selected per ISO 19232‑1/2. IQI material should be appropriate to specimen dimensions and preferably similar to the test object.
• Inspection levels: Unless otherwise justified, inspection is 100% of the lot.
• Acceptance limits: Annex A provides recommended acceptance criteria for single imperfections and groups (size, number, separation and image density). Linear imperfections with a length:width ratio greater than 3:1 are generally not acceptable.
• Personnel certification: Radiographic imaging operators require ISO 9712 Level I certification; radiographic examiners require Level II or III and specific training for medical implant product ranges.
• Reporting and traceability: Radiographs and evaluations must be recorded, traceable to the product, and stored in a format that preserves image quality; records retained per applicable good manufacturing practice.

Practical applications and users

• Medical implant manufacturers using cast Co, Fe or Ti alloys - for incoming inspection, production control, and final release testing.
• Third‑party radiographic service providers performing implant NDT under manufacturer‑established methods.
• Quality, regulatory and R&D teams in orthopaedics and surgical device manufacturing seeking standardized film‑based radiography practices.
• NDT personnel and auditors ensuring compliance with implant acceptance criteria and personnel certification requirements.

Related standards

• ISO 5579 (radiographic testing basics)
• ISO 19232‑1/2/3 (image quality indicators and classes)
• ISO 5580 (radiographic illuminators)
• ISO 9712 (NDT personnel certification)
• ASTM F629, ASTM F2895 (radiography guidance for implants)
• EN 10204 (inspection documentation)

Keywords: ISO 9584:2023, radiographic examination, cast metallic surgical implants, non‑destructive testing, NDT, image quality indicator, acceptance limits, medical implant radiography, ISO 19232, ISO 9712.

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 9584
Second edition
2023-10
Implants for surgery — Non-
destructive testing — Radiographic
examination of cast metallic surgical
implants
Implants chirurgicaux — Essais non destructifs — Contrôle
radiographique des implants chirurgicaux métalliques moulés
Reference number
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
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or ISO’s member body in the country of the requester.
ISO copyright office
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Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Inspection procedure .2
4.1 General . 2
4.2 Radiographic method . 2
4.3 Image quality indicator . 3
4.4 Image quality . 3
4.5 Radiographic examination . 3
5 Inspection levels . 3
6 Acceptance limits . 3
7 Personnel certification .4
7.1 Radiographic imaging . 4
7.2 Radiographic examination . 4
8 Report . 4
Annex A (informative) Radiographic examination of cast metallic surgical implants —
Acceptance limits for internal imperfections . 5
Bibliography . 7
iii
Foreword
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electrotechnical standardization.
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described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO document should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use
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expressions related to conformity assessment, as well as information about ISO's adherence to
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www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee
SC 1, Materials.
This second edition cancels and replaces the first edition (ISO 9584:1993) which has been technically
revised.
The main changes compared to the previous edition are as follows:
— normative references, and terms and definitions have been updated;
— applicable radiographic approach for components based on Co, Fe and Ti alloys have been added;
— applicable requirements for image quality indicator, acceptance limits and personal certification
have been added.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
INTERNATIONAL STANDARD ISO 9584:2023(E)
Implants for surgery — Non-destructive testing —
Radiographic examination of cast metallic surgical
implants
1 Scope
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”.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 5576, Non-destructive testing — Industrial X-ray and gamma-ray radiology — Vocabulary
ISO 5579, Non-destructive testing — Radiographic testing of metallic materials using film and X- or gamma
rays — Basic rules
ISO 5580, Non-destructive testing — Industrial radiographic illuminators — Minimum requirements
ISO 9712, Non-destructive testing — Qualification and certification of NDT personnel
ISO 19232-1, Non-destructive testing — Image quality of radiographs — Part 1: Determination of the
image quality value using wire-type image quality indicators
ISO 19232-2, Non-destructive testing — Image quality of radiographs — Part 2: Determination of the
image quality value using step/hole-type image quality indicators
ISO 19232-3, Non-destructive testing — Image quality of radiographs — Part 3: Image quality classes
1)
ASTM F629, Standard Practice for Radiography of Cast Metallic Surgical Implants
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 5576 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO
...