I.S. EN ISO 14607:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
NON-ACTIVE SURGICAL IMPLANTS - MAMMARY IMPLANTS - PARTICULAR REQUIREMENTS (ISO 14607:2018)
Hardcopy , PDF
02-04-2019
English
01-01-2009
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.
National Foreword
European foreword
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
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 93/42/EEC [OJ L 169]
aimed to be covered
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