NF EN ISO 14607

NF EN ISO 14607

May 2018
Standard Current

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.

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Main informations

Collections

National standards and national normative documents

Publication date

May 2018

Number of pages

57 p.

Reference

NF EN ISO 14607

ICS Codes

11.040.40   Implants for surgery, prosthetics and orthotics

Classification index

S94-350

Print number

2 - 01/06/2019

International kinship

ISO 14607:2018

European kinship

EN ISO 14607:2018
Sumary
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.

Replaced standards (1)
NF EN ISO 14607
November 2009
Standard Cancelled
Non-active surgical implants - Mammary implants - Particular requirements

<p>ISO 14607:2007 specifies particular requirements for mammary implants for clinical practice.</p> <p>With regard to safety, ISO 14607:2007 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.</p>

Table of contents
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  • 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 de l'octaméthylcyclotétrasiloxane (D4) et du décaméthylcyclopentasiloxane (D5) 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 Méthode d'essai relative à l'étanchéité de la valve et du site d'injection
  • Annexe E Essai visant à contrôler la cohésion du gel de silicone (uniquement les matériaux de remplissage à base de silicone)
  • Annexe F Essai visant à contrôler la pénétration du gel de silicone (produits de remplissage à base de silicone uniquement)
  • Annexe G Évaluation de la diffusion de silicone des implants mammaires en utilisant une méthode in vitro
  • Annexe H Essai relatif aux caractéristiques de la surface
  • Annexe I Informations destinées à l'utilisateur
  • Annexe J Informations destinées au patient
  • Bibliographie
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