NF EN ISO 14607

NF EN ISO 14607

August 2025
Standard Current

Non-active surgical implants - Mammary implants - Specific requirements

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Main informations

Collections

National standards and national normative documents

Publication date

August 2025

Number of pages

71 p.

Reference

NF EN ISO 14607

ICS Codes

11.040.40   Implants for surgery, prosthetics and orthotics

Classification index

S94-350

Print number

1

International kinship

ISO 14607:2024

European kinship

EN ISO 14607:2025
Replaced standards (1)
NF EN ISO 14607
May 2018
Standard Cancelled
Non-active surgical implants - Mammary implants - Particular requirements

ISO 14607:2018 specifies particular requirements for mammary implants. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization, and information supplied by the manufacturer.

Table of contents
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Performances prévues
  • 5 Caractéristiques de conception
  • 6 Matériaux
  • 7 Évaluation de la conception
  • 8 Fabrication
  • 9 Stérilisation
  • 10 Emballage
  • 11 Informations fournies par le fabricant
  • Annexe A Dosage du D4, du D5 et du D6 dans les gels de silicone
  • Annexe B Essais portant sur l'intégrité de l'enveloppe
  • Annexe C Essais mécaniques portant sur un implant mammaire à l'état implantable
  • Annexe D Essais d'étanchéité de la valve et du site d'injection
  • Annexe E Essai visant à contrôler la cohésion du gel de silicone pour les matériaux de remplissage à base de silicone uniquement
  • Annexe F Essai visant à contrôler la pénétration du gel de silicone pour les produits de remplissage à base de silicone uniquement
  • Annexe G Classification des surfaces
  • Annexe H Informations destinées à l'utilisateur
  • Annexe I Brochure d'informations pour les patients
  • Annexe J Essais relatifs à la contamination particulaire de la surface
  • Annexe ZA Relation entre la présente Norme européenne et les exigences générales en matière de sécurité et de performances concernées du Règlement (UE) 2017/745
  • Bibliographie
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