ISO/FDIS 14630

Non-active surgical implants — General requirements

Implants chirurgicaux non actifs — Exigences générales

General Information

• Status: Not Published
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: ISO/TC 150 - Implants for surgery
• Drafting Committee: ISO/TC 150/WG 7 - Fundamental standards
• Current Stage: 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
• Start Date: 19-Apr-2024
• Completion Date: 19-Apr-2024

Relations

• Consolidates: ISO/IEC 19086-4:2019 - Cloud computing — Service level agreement (SLA) framework — Part 4: Components of security and of protection of PII
• Effective Date: 06-Jun-2022
• Revises: ISO 14630:2012 - Non-active surgical implants — General requirements
• Effective Date: 23-Apr-2020

Standards Content (Sample)

FINAL DRAFT
International
Standard
ISO/FDIS 14630
ISO/TC 150
Non-active surgical implants —
Secretariat: DIN
General requirements
Voting begins on:
Implants chirurgicaux non actifs — Exigences générales 2024-04-19
Voting terminates on:
2024-06-14
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
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING 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.
Reference number
ISO/FDIS 14630:2024(en) © ISO 2024

---------------------- Page: 1 ----------------------
FINAL DRAFT
ISO/FDIS 14630:2024(en)
International
Standard
ISO/FDIS 14630
ISO/TC 150
Non-active surgical implants —
Secretariat: DIN
General requirements
Voting begins on:
Implants chirurgicaux non actifs — Exigences générales
Voting terminates on:
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
COPYRIGHT PROTECTED DOCUMENT
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2024
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
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 Reference number
ISO/FDIS 14630:2024(en) © ISO 2024

© ISO 2024 – All rights reserved
ii

---------------------- Page: 2 ----------------------
ISO/FDIS 14630:2024(en)
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Intended performance . 6
5 Design attributes . 6
6 Selection of materials . 7
7 Design evaluation . 8
7.1 General .8
7.2 Pre-clinical evaluation . .8
...

ISO/DIS FDIS 14630:20232024(E)
ISO TC 150/WG 7 N XXX
Secretariat: DIN
Non-active surgical implants — General requirements
Implants chirurgicaux non actifs — Exigences générales
Fifth edition
2023-05-15

Document type:  International Standard
Document subtype:
Document stage:  (50) Final Draft
Document language:  E

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Date: 2024-04-18
Document type:  International Standard
Document subtype:
Document stage:  (50) Final Draft
Document language:  E

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ISO/FDIS 14630:2024(E)
© ISO 20232024
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: [e-mail]
Website: www.iso.org
Published in Switzerland.
iv © ISO 2024 – All rights reserved

---------------------- Page: 3 ----------------------
ISO/FDIS 14630:2024(E)
Contents Page
Foreword . 6
Introduction . 8
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Intended performance . 7
5 Design attributes . 7
6 Selection of materials . 9
7 Design evaluation . 10
7.1 General . 10
7.2 Pre-clinical evaluation . 10
7.3 Clinical evaluation and clinical investigation . 12
7.4 Post-market surveillance . 12
8 Manufacture . 13
9 Sterilization . 13
9.1 Implants supplied sterile . 13
9.2 Implants supplied non-sterile . 14
9.3 Re-sterilizable implants . 14
9.4 Sterilization residuals . 14
10 Packaging . 14
10.1 Protection from damage in transport, storage and handling . 14
10.2 Maintenance of sterility in transport, storage and handling .
...