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

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
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
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
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
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
of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed
patent rights in respect thereof. As of the date of publication of this document, ISO had not received
notice of (a) patent(s) which may be required to implement this document. However, implementers are
cautioned that this may not represent the latest information, which may be obtained from the patent
database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all
such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
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
...