ISO 14630
(Main)Non-active surgical implants — General requirements
Non-active surgical implants — General requirements
Implants chirurgicaux non actifs — Exigences générales
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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
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WITH THEIR COMMENTS, NOTIFICATION OF ANY
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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
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,
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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/FDIS 14630:2024(en) © ISO 2024
ii
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
7.3 Clinical evaluation and clinical investigation .10
7.4 Post-market surveillance .11
8 Manufacture .11
9 Sterilization .11
9.1 Implants supplied sterile .11
9.2 Implants supplied non-sterile . 12
9.3 Re-sterilizable implants . 12
9.4 Sterilization residuals . 12
10 Packaging.12
10.1 Protection from damage in transport, storage and handling . 12
10.2 Maintenance of sterility in transport, storage and handling . 13
10.3 Use by date . 13
11 Information supplied by the manufacturer .13
11.1 General . 13
11.2 Marking on implants .14
11.3 Label .14
11.4 Instructions for use .16
11.5 Patient record label(s) .17
11.6 Implant card . .18
11.7 Implants for special purposes.18
Annex ZA (informative) Relationship between this European Standard the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be covered . 19
Bibliography .23
iii
ISO/FDIS 14630:2024(en)
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, in collaboration
with the European Committee for Standardization (CEN) Technical Committee CEN/TC 285, Non-active
surgical implants, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna
Agreement).
This fifth edition cancels and replaces the fourth edition (ISO 14630:2012), which has been technically
revised.
The main changes are as follows:
— the scope has been revised to clarify that this document does not apply to implants utilizing viable animal
or human tissue;
— definitions have been added for clinical evaluation and clinical investigation based on the International
Medical Device Regulators Forum (IMDRF) guidance on Clinical Evaluation;
— definitions have been added for demonstrably similar implant and reference implant to clarify when
data for other implants can be used during pre-clinical and clinical evaluation of the implant under
investigation;
— indications, contraindications and target patient population have been added in Clause 4 to the list of
factors to consider when establishing the intended performance of an implant;
— reorganized list of design attributes in Clause 5 to put then in a more logical sequence;
— revised Clause 6 on selection of material to use a risk analysis as the basis for selection of implant
materials and to list factors to be taken into account when performing the risk analysis;
— Clause 7 has been significantly expanded on design evaluation to address pre-clinical evaluation, clinical
evaluation and investigation, and post-market surveillance in more detail;
— Clause 8 has been expanded on manufacturing to address cleanliness of the implant;
iv
ISO/FDIS 14630:2024(en)
— Subclause 9.1 has been revised to list the methods of sterilizing the implant in a tabular form rather than
as running text;
— a new subclause 10.3 has been added to address the determination of use by date;
— Clause 11 has been revised on information supplied by the manufacturer to include new subclauses
addressing patient record labels (11.5) and implant card (11.6);
— the subclause on Restrictions on combinations (11.4 in ISO 14630:2012) has been deleted because the
safety of combinations is addressed in design attribute 5 l).
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.
v
ISO/FDIS 14630:2024(en)
Introduction
There are three levels of standards dealing with non-active surgical implants and related instrumentation.
For the implants themselves, they are as follows, with Level 1 being the highest:
— Level 1: General requirements for non-active surgical implants;
— Level 2: Particular requirements for families of non-active surgical implants;
— Level 3: Specific requirements for types of non-active surgical implants.
Level 1 standards include this document which contains requirements that apply to all non-active surgical
...
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
D:\tmp\prod_iso_macroserver\DOC2PDFRGB\DOC2PDFRGB.jain@W-
GM01BCVV_1\C076810e_trackchanges.doc
Date: 2024-04-18
Document type: International Standard
Document subtype:
Document stage: (50) Final Draft
Document language: E
D:\tmp\prod_iso_macroserver\DOC2PDFRGB\DOC2PDFRGB.jain@W-
GM01BCVV_1\C076810e_trackchanges.doc
ISO/FDIS 14630:2024(E)
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.
iv © ISO 2024 – All rights reserved
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 . 15
10.3 Use by date . 15
11 Information supplied by the manufacturer . 15
11.1 General . 15
11.2 Marking on implants . 16
11.3 Label . 16
11.4 Instructions for use . 18
11.5 Patient record label(s) . 20
11.6 Implant card . 20
11.7 Implants for special purposes . 21
Annex ZA (informative) Relationship between this European Standard the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered . 21
Bibliography . 29
ISO/FDIS 14630:2024(E)
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 documentsdocument 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). Field Code Changed
Attention is drawnISO draws attention to the possibility that some of the elementsimplementation of
this document may beinvolve the subjectuse 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. Details of any patent rights
identified during the development of the document will be in the Introduction and/or on the ISO list of
patent declarations received (see ).
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, in collaboration
with the European Committee for Standardization (CEN) Technical Committee CEN/TC 285, Non-active
surgical implants, in accordance with the Agreement on technical cooperation between ISO and CEN
(Vienna Agreement).
This fifth edition cancels and replaces the fourth edition (ISO 14630:2012), which has been technically
revised.
The main changes are as follows:
— revised the scope has been revised to clarify that this standarddocument does not apply to implants
utilizing viable animal or human tissue;
— definitions arehave been added for clinical evaluation and clinical investigation based on the
International Medical Device Regulators Forum (IMDRF) guidance on Clinical Evaluation;
— definitions arehave been added for demonstrably similar implant and reference implant to clarify
when data for other implants can be used during pre-clinical and clinical evaluation of the implant
under investigation;
vi © ISO 2024 – All rights reserved
ISO/FDIS 14630:2024(E)
— indications, contraindications and target patient population washave been added in Clause 4 to the
list of factors to consider when establishing the intended performance of aan implant;
— reorganized list of design attributes in Clause 5 to put then in a more logical sequence;
— revised Clause 6 on selection of material to use a risk analysis as the basis for selection of implant
materials and to list factors to be taken into account when performing the risk analysis;
— Clause 7 has been significantly expanded Clause 7 on design evaluation to address pre-clinical
evaluation, clinical evaluation and investigation, and post-market surveillance in more detail;
— Clause 8 has been expanded Clause 8 on manufacturing to address cleanliness of the implant;
— revised Subclause 9.1 has been revised to list the methods of sterilizing the implant in a tabular
form rather thatthan as running text;
— added a new subclause (10.3) has been added to address the determination of use by date;
— revised Clause 11 has been revised on information supplied by the manufacturer to include new
subclauses addressing patient record labels (11.5) and implant card (11.6));
— deleted the subclause on Restrictions on combinations (11.4 in ISO 14630:2012) has been deleted
because the safety of combinations is addressed in design attribute 5 l).
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.
ISO/FDIS 14630:2024(E)
Introduction
There are three levels of standards dealing with non-active surgical implants and related
instrumentation. For the implants themselves, they are as follows, with Level 1 being the highest.:
— Level 1: General requirements for non-active surgical implants.;
— Level 2: Particular requirements for families of non-active surgical implants.;
— Level 3: Specific requirements for types of non-active surgical implants.
Level 1 standards include this document which contains requirements that apply to all non-active
surgical implants, ISO 16061, which contains requirement for instruments associated with non-active
surgical implants. They also anticipate that there are additional requirements in the Level 2 and Level 3
standards.
Level 2 standards (see References [2], [12], [23], [27] and [42]) apply to a more restricted set or family
of non-active surgical implants, such as those designed for use in neurosurgery, cardiovascular surgery
or joint replacement.
Level 3 standards (see References [3], [13], [24] and [25]) apply to specific types of implants within a
family of non-active surgical implants, such as hip joints or arterial stents.
To address the requirements for a specific implant, all related Level 1, 2 and 3 standards should be
applied.
viii © ISO 2024 – All rights reserved
FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 14630:2024(E)
Non-active surgical implants — General requirements
1 Scope
This document specifies general requirements for non-active surgical implants, hereafter referred to as
implants.
This document is not applicable to dental implants, dental restorative materials, transendodontic and
transradicular implants, intra-ocular lenses and implants utilizing viable animal or human tissue.
With regard to safety, this document specifies requirements for intended performance, design
attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied
by the manufacturer, and tests to demonstrate compliance with these requirements.
Additional requirements applicable to specific implants or implant families are given or referred to in
Level 2 and Level 3 standards.
NOTE 1 This document does not require that the manufacturer have a quality management system in place.
However, many regulatory authorities require the application of a quality management system, such as that
described in ISO 13485, to ensure that the implant achieves its intended performance and safety.
NOTE 2 In this document, when not otherwise specified, the term "implant" refers to each individual component
of a system or a modular implant, provided separately or as a set of components, as well as to all ancillary
implants or associated implants designed for improving the intended performance.
2 Normative references
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