kSIST FprEN ISO 14607:2024

Non-active surgical implants - Mammary implants - Specific requirements (ISO/FDIS 14607:2024)

Nichtaktive chirurgische Implantate - Mammaimplantate - Besondere Anforderungen (ISO/FDIS 14607:2024)

Dieses Dokument legt besondere Anforderungen an Mammaimplantate fest.
Im Hinblick auf die Sicherheit legt dieses Dokument Anforderungen an die beabsichtigte Funktion, Merkmale der Ausführung, Werkstoffen/Materialien, Bewertung der Ausführung, Herstellung, Verpackung, Sterilisation und vom Hersteller bereitzustellenden Informationen fest.

Implants chirurgicaux non actifs - Implants mammaires - Exigences particulières (ISO/FDIS 14607:2024)

Neaktivni kirurški vsadki (implantati) - Prsni vsadki - Posebne zahteve (ISO/FDIS 14607:2024)

General Information

• Status: Not Published
• Public Enquiry End Date: 01-Nov-2023
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: VAZ - Healthcare
• Current Stage: 5020 - Formal vote (FV) (Adopted Project)
• Start Date: 01-Aug-2024
• Due Date: 19-Sep-2024
• Completion Date: 05-Aug-2024
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: FprEN ISO 14607 - Non-active surgical implants - Mammary implants - Specific requirements(ISO/FDIS 14607:2024)

Relations

• Revises: SIST EN ISO 14607:2018 - Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08)
• Effective Date: 04-Nov-2020

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 14607:2023
01-oktober-2023
Neaktivni kirurški vsadki (implantati) - Prsni vsadki - Posebne zahteve (ISO/DIS
14607:2023)
Non-active surgical implants - Mammary implants - Particular requirements (ISO/DIS
14607:2023)
Nichtaktive chirurgische Implantate - Mammaimplantate - Besondere Anforderungen
(ISO/DIS 14607:2023)
Implants chirurgicaux non actifs - Implants mammaires - Exigences particulières
(ISO/DIS 14607:2023)
Ta slovenski standard je istoveten z: prEN ISO 14607
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 14607:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 14607:2023
oSIST prEN ISO 14607:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 14607
ISO/TC 150 Secretariat: DIN
Voting begins on: Voting terminates on:
2023-08-11 2023-11-03
Non-active surgical implants — Mammary implants —
Specific requirements
ICS: 11.040.40
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 14607:2023(E)
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 SUPPORTING DOCUMENTATION. © ISO 2023

oSIST prEN ISO 14607:2023
ISO/DIS 14607:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 14607
ISO/TC 150 Secretariat: DIN
Voting begins on: Voting terminates on:

Non-active surgical implants — Mammary implants —
Specific requirements
ICS: 11.040.40
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: [phone]
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: [e-mail]
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 14607:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

oSIST prEN ISO 14607:2023
ISO/DIS 14607:2023(E)
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 .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 . 4
6.4.1 General . 4
6.4.2 Intentionally added trace elements . 5
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 . 9
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 octamethylcyclotetrasiloxane (D4),
decamethylcyclopentasiloxane (D5) and dodecamethylcyclohexasiloxane (D6) in
silicone gels.13
Annex B (normative) Tests for shell integrity .17
Annex C (normative) Mechanical tests on a mammary implant in its implantable state .20
Annex D (normative) Test method for valve competence and injection site competence .30
iii
oSIST prEN ISO 14607:2023
ISO/DIS 14607:2023(E)
Annex E (normative) Test for silicone gel cohesion (silicone filling materials only) .33
Annex F (normative) Test for silicone gel penetration (silicone filling materials only) .35
Annex G (normative) Test for surface characteristics .40
Annex H (normative) Information for the user .46
Annex I (normative) Patient information brochure .48
Annex J (normative) Tests for surface particulate contamination .51
Annex ZA (informative) Relationship between this European Standard the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered .54
Bibliography .58
iv
oSIST prEN ISO 14607:2023
ISO/DIS 14607:2023(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
commit
...