NF EN ISO 14630

NF EN ISO 14630

February 2013
Standard Current

Non-active surgical implants - General requirements

ISO 14630:2012 specifies general requirements for non-active surgical implants. ISO 14630:2012 is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue. With regard to safety, ISO 14630:2012 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements.

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Main informations

Collections

National standards and national normative documents

Publication date

February 2013

Number of pages

25 p.

Reference

NF EN ISO 14630

ICS Codes

11.040.40   Implants for surgery, prosthetics and orthotics

Classification index

S94-001

Print number

1 - 23/01/2013

International kinship

ISO 14630:2012

European kinship

EN ISO 14630:2012
Sumary
Non-active surgical implants - General requirements

ISO 14630:2012 specifies general requirements for non-active surgical implants. ISO 14630:2012 is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue.

With regard to safety, ISO 14630:2012 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements.

Replaced standards (1)
NF EN ISO 14630
September 2009
Standard Cancelled
Non-active surgical implants - General requirements

<p>ISO 14630:2008 specifies general requirements for non-active surgical implants. ISO 14630:2008 is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue.</p> <p>With regard to safety, ISO 14630:2008 gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements. Additional tests are given or referred to in level 2 and level 3 standards.</p>

Table of contents
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  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Performances prévues
    3
  • 5 Caractéristiques de conception
    3
  • 6 Matériaux
    4
  • 7 Évaluation de la conception
    5
  • 7.1 Généralités
    5
  • 7.2 Évaluation préclinique
    5
  • 7.3 Évaluation clinique
    6
  • 7.4 Surveillance après commercialisation
    6
  • 8 Fabrication
    7
  • 9 Stérilisation
    7
  • 9.1 Généralités
    7
  • 9.2 Produits fournis à l'état stérile
    7
  • 9.3 Stérilisation par l'utilisateur
    7
  • 9.4 Résidus de stérilisation
    8
  • 10 Emballage
    8
  • 10.1 Protection contre les dommages au cours du stockage et du transport
    8
  • 10.2 Maintien de la stérilité pendant le transport
    8
  • 11 Informations fournies par le fabricant
    8
  • 11.1 Généralités
    8
  • 11.2 Étiquetage
    9
  • 11.3 Instructions d'utilisation
    10
  • 11.4 Restrictions relatives aux combinaisons
    11
  • 11.5 Marquage des implants
    11
  • 11.6 Marquage pour utilisations spéciales
    11
  • Bibliographie
    12
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