ISO 9584:2023
(Main)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
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
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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 9584:2023(E)
© ISO 2023
---------------------- Page: 1 ----------------------
ISO 9584:2023(E)
COPYRIGHT PROTECTED DOCUMENT
© 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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
© ISO 2023 – All rights reserved
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ISO 9584:2023(E)
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 .
...
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 9584
ISO/TC 150/SC 1
Implants for surgery — Non-
Secretariat: DIN
destructive testing — Radiographic
Voting begins on:
2023-07-07 examination of cast metallic surgical
implants
Voting terminates on:
2023-09-01
Implants chirurgicaux — Essais non destructifs — Contrôle
radiographique des implants chirurgicaux métalliques moulés
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 9584:2023(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO 2023
---------------------- Page: 1 ----------------------
ISO/FDIS 9584:2023(E)
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 9584
ISO/TC 150/SC 1
Implants for surgery — Non-
Secretariat: DIN
destructive testing — Radiographic
Voting begins on:
examination of cast metallic surgical
implants
Voting terminates on:
Implants chirurgicaux — Essais non destructifs — Contrôle
radiographique des implants chirurgicaux métalliques moulés
COPYRIGHT PROTECTED DOCUMENT
© 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.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
ISO copyright office
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
CP 401 • Ch. de Blandonnet 8
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
CH-1214 Vernier, Geneva
DOCUMENTATION.
Phone: +41 22 749 01 11
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: copyright@iso.org
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/FDIS 9584:2023(E)
Website: www.iso.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
© ISO 2023 – All rights reserved
NATIONAL REGULATIONS. © ISO 2023
---------------------- Page: 2 ----------------------
ISO/FDIS 9584:2023(E)
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 Accept
...
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ISO/FDIS 9584.2:2023(E)
ISO/TC 150/SC 1/WG 4
Secretariat: DIN
Implants for surgery — Non-destructive testing — Radiographic examination of
cast metallic surgical implants
Implants chirurgicaux — Essais non destructifs — Contróle radiographique des implants
chirurgicaux métalliques moulés
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COPYRIGHT PROTECTED DOCUMENT
Second edition
Date: 2023-06-23
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ISO/FDIS 9584:2023(E)
© ISO 20212023
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-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland.
ii © ISO 2023 – All rights reserved
---------------------- Page: 3 ----------------------
ISO/FDIS 9584:2023(E)
Contents Page
Foreword . iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Inspection procedure . 3
4.1 General . 3
4.2 Radiographic method . 3
4.3 Image quality indicator . 4
4.4 Image quality . 4
4.5 Radiographic examination . 5
5 Inspection levels . 5
6 Acceptance limits . 5
7 Personnel certification . 5
7.1 Radiographic imaging . 5
7.2 Radiographic examination . 5
8 Report . 6
Annex A (informative) Radiographic examination of cast metallic surgical implants -
acceptance limits for internal imperfections . 7
Bibliography . 9
© ISO 2023 – All rights reserved iii
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ISO/FDIS 958
...
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