BS EN ISO 14607:2009
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Hardcopy , PDF
09-28-2018
English
11-30-2009
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) - Test for surface characteristics
Annex B (normative) - Tests for shell integrity
Annex C (normative) - Test method for valve competence and
injection site competence
Annex D (normative) - Test for silicone gel cohesion
(silicone filling materials only)
Annex E (normative) - Mechanical tests on a mammary implant
in its implantable state
Annex F (normative) - Information for the patient
Annex G (normative) - Information for the user
Annex H (informative) - Silicone release assessment from
mammary implants by an in vitro
method
Bibliography
Annex ZA (informative) - Relationship between this European
Standard and the Essential
Requirements of EU Directive 93/42/EEC
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