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Non-active surgical implants. Body contouring implants. Specific requirements for mammary implants
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Available format(s): Hardcopy, PDF
Superseded date: 31-12-2008
Language(s): English
Published date: 15-06-2000
Publisher: British Standards Institution
ForewordIntroduction1 Scope2 Normative references3 Definitions4 Intended performance5 Design attributes6 Materials7 Design evaluation8 Manufacturing9 Sterilization10 Packaging11 Information supplied by the manufacturerAnnex A (normative) Surface characteristicsAnnex B (normative) Tests for shell integrityAnnex C (normative) Test requirements for valve competence and injection site competenceAnnex D (normative) Tests for silicone gel cohesionAnnex E (normative) Mechanical tests on mammary implant in its implantable stateAnnex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU DirectivesBibliography
Defines specific criteria for mammary implants for clinical practice. Gives the requirements for intended performance, design attributes and evaluation, materials, manufacturing, sterilization, information and packaging supplied by the manufacturer.
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