ISO/FDIS 14607
(Main)Non-active surgical implants — Mammary implants — Specific requirements
Non-active surgical implants — Mammary implants — Specific requirements
Implants chirurgicaux non actifs — Implants mammaires — Exigences particulières
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FINAL DRAFT
International
Standard
ISO/TC 150
Non-active surgical implants —
Secretariat: DIN
Mammary implants — Specific
Voting begins on:
requirements
2024-07-22
Implants chirurgicaux non actifs — Implants mammaires —
Voting terminates on:
Exigences particulières
2024-09-16
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
FINAL DRAFT
International
Standard
ISO/TC 150
Non-active surgical implants —
Secretariat: DIN
Mammary implants — Specific
Voting begins on:
requirements
2024-07-22
Implants chirurgicaux non actifs — Implants mammaires —
Voting terminates on:
Exigences particulières
2024-09-16
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
ii
Contents Page
Foreword .v
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Intended performance . 3
5 Design attributes . 3
6 Materials . 4
6.1 General .4
6.2 Cytotoxicity .4
6.3 Silicone gel residual low molecular weight oligomers .4
6.4 Trace elements .4
6.4.1 General .4
6.4.2 Limits on trace elements present as impurities .4
6.4.3 Intentionally added trace elements .4
6.5 Physico-mechanical properties and characterization .5
6.6 Documentation of materials .5
7 Design evaluation . 5
7.1 General .5
7.2 Pre-clinical evaluation . .6
7.2.1 General .6
7.2.2 Mechanical tests .6
7.2.3 Physical evaluation.7
7.2.4 Chemical evaluation .8
7.2.5 Biological evaluation.9
7.3 Clinical evaluation .9
7.4 Post-market surveillance .9
8 Manufacturing . 9
8.1 General .9
9 Sterilization . 10
10 Packaging. 10
11 Information supplied by the manufacturer . 10
11.1 General .10
11.2 Marking on implants .10
11.3 Label .10
11.4 Instructions for use .10
11.5 Patient record label(s) .10
11.6 Additional information for the user.11
11.7 Information on expected lifetime .11
11.8 Information for the patient .11
11.8.1 General .11
11.8.2 Patient information brochure . 12
11.8.3 Implant card . 12
Annex A (normative) Determination of D4, D5 and D6 in silicone gels .13
Annex B (normative) Tests of shell integrity . 17
Annex C (normative) Mechanical tests on a mammary implant in its implantable state .20
Annex D (normative) Tests of valve competence and injection site competence .29
Annex E (normative) Test of silicone gel cohesion for silicone filling materials only .31
iii
Annex F (normative) Test of silicone gel penetration for silicone filling materials only .33
Annex G (normative) Surface classification .38
Annex H (normative) Information for the user .44
Annex I (normative) Patient information brochure .46
Annex J (normative) Tests of surface particulate contamination .49
Annex ZA (informative) Relationship between this European Standard the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be covered .53
Bibliography .57
iv
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
...
ISO/DISFDIS 14607:2023(E)
ISO/TC 150
Secretariat: DIN
Date: 2024-07-19
Non-active surgical implants — Mammary implants — Specific
requirements
Implants chirurgicaux non actifs — Implants mammaires — Exigences particulières
Fourth edition
Date: 2023-11-01
FDIS stage
ISO/DISFDIS 14607:2023(E2024(en)
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
EmailE-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
iii
ISO/DISFDIS 14607:2023(E2024(en)
Contents
Foreword . viii
Introduction . x
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Intended performance . 4
5 Design attributes . 4
6 Materials. 4
6.1 General . 4
6.2 Cytotoxicity . 4
6.3 Silicone gel residual low molecular weight oligomers . 4
6.4 Trace elements . 5
6.4.1 General . 5
6.4.2 Limits on trace elements present as impurities . 5
6.4.3 Intentionally added trace elements . 5
6.5 Physico-mechanical properties and characterization . 5
6.6 Documentation of materials . 6
7 Design evaluation . 6
7.1 General . 6
7.2 Pre-clinical evaluation . 6
7.2.1 General . 6
7.2.2 Mechanical tests . 7
7.2.3 Physical evaluation . 8
7.2.4 Chemical evaluation . 10
7.2.5 Biological evaluation . 10
7.3 Clinical evaluation . 10
7.4 Post-market surveillance . 10
8 Manufacturing . 11
8.1 General . 11
9 Sterilization . 11
10 Packaging . 11
11 Information supplied by the manufacturer . 11
11.1 General . 11
11.2 Marking on implants . 11
11.3 Label . 11
11.4 Instructions for use . 12
11.5 Patient record label(s) . 12
11.6 Additional information for the user . 12
11.7 Information on expected lifetime . 12
11.8 Information for the patient . 13
11.8.1 General . 13
11.8.2 Patient information brochure . 13
iv
iv
ISO/DISFDIS 14607:2023(E2024(en)
11.8.3 Implant card . 13
Annex A (normative) Determination of D4, D5 and D6 in silicone gels . 15
A.1 Objective . 15
A.2 Principle . 15
A.3 Test specimen preparation . 15
A.4 Reagents . 15
A.5 Apparatus . 16
A.6 Experimental precautions . 16
A.7 Procedure . 16
A.7.1 Number of experiments . 16
A.7.2 Preparation of calibration standards and construction of calibration curves . 16
A.7.3 Test specimen analysis . 17
A.8 Calculation . 17
A.9 Specification . 17
A.10 Analytical validation. 17
A.11 Test report . 18
Annex B (normative) Tests of shell integrity . 19
B.1 Test specimen preparation . 19
B.2 Shell material . 19
B.2.1 Elongation . 19
B.2.2 Tensile set . 19
B.3 Strength of seams . 19
B.3.1 General . 19
B.3.2 Critical seams . 20
B.3.3 Non-critical seams . 21
B.4 Test report . 21
Annex C (normative) Mechanical tests on a mammary implant in its implantable state . 23
C.1 Fatigue test . 23
C.1.1 Principle . 23
C.1.2 Materials. 23
C.1.3 Apparatus . 23
C.1.4 Procedure . 25
C.1.5 Requirements . 26
C.1.6 Test report . 26
C.2 Impact resistance test . 27
C.2.1 Principle . 27
C.2.2 Apparatus . 27
C.2.3 Procedure . 28
C.2.4 Requirement . 31
C.2.5 Test report . 31
C.3 Endurance load level . 31
C.3.1 Principle . 31
C.3.2 Materials.
...
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