Foreword

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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 fourth edition cancels and replaces the third edition (ISO 14607:2018), which has been technically revised.

The main changes are as follows:

— trace elements subclause (6.4) has been revised;
— language regarding biological evaluation and risk management has been revised and expanded in the general part of the pre-clinical evaluation subclause (7.2.1);
— contamination subclause has been renamed to particulate contamination (7.2.3.8) and completely revised;
— requirements regarding implantation studies have been added (7.2.5);
— clinical evaluation requirements have been expanded (7.3);
— surface category has been added to the label requirements (11.3);
— Annex C “Mechanical tests on a mammary implant in its implantable state” has been expanded and revised;
— the fatigue resistance testing method (Clauses C.1 and C.3) has been revised and expanded;
— Annex F “Test for silicone gel penetration (silicone filling materials only)” has been re-structured and the language has been clarified;
— Annex G “Assessment of silicone diffusion from mammary implants using an in vitro method” has been deleted as the test method given in the annex did not accomplish its purpose;
— Annex H “Test for surface characteristics” has been re-numbered as Annex G and has been renamed “Surface classification”, its status has been changed to normative, it has completely revised and an expanded surface classification has been added;
— Annex J “Tests for surface particulate contamination” has been newly added;
— the language of test report subclauses in all annexes has been harmonized as much as possible.

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 14607:2024

Non-active surgical implants. Mammary implants. Specific requirements

Current

Published:

2 Dec 2024