I.S. EN ISO 14607:2018&LC:2018
Current
The latest, up-to-date edition.
Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08)
Hardcopy , PDF
English
01-30-2019
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
6 Materials
7 Design evaluation
8 Manufacturing
9 Sterilization
10 Packaging
11 Information supplied by the manufacturer
Annex A (normative) Determination of octamethylcyclotetrasiloxane (D4) and
decamethylcyclopentasiloxane (D5) in silicone gels
Annex B (normative) Tests for shell integrity
Annex C (normative) Mechanical tests on a mammary implant in its implantable state
Annex D (normative) Test method for valve competence and injection site competence
Annex E (normative) Test for silicone gel cohesion (silicone filling materials only)
Annex F (normative) Test for silicone gel penetration (silicone filling materials only)
Annex G (informative) Assessment of silicone diffusion from mammary implants using an
in vitro method
Annex H (informative) Test for surface characteristics
Annex I (normative) Information for the user
Annex J (normative) Information for the patient
Bibliography
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