NF EN ISO 14630
NF EN ISO 14630

NF EN ISO 14630

February 2013
Standard Cancelled

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 - janvier 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
NF EN ISO 14630
August 2009
Standard Cancelled
Non-active surgical implants - General requirements

Standard replaced by (1)
NF EN ISO 14630
NF EN ISO 14630
December 2024
Standard Current
Non-active surgical implants - General requirements

This document specifies general requirements for non-active surgical implants, hereafter referred to as implants. This document is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal or human tissue. With regard to safety, this document 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. Additional requirements applicable to specific implants or implant families are given or referred to in Level 2 and Level 3 standards. NOTE 1        This document does not require that the manufacturer have a quality management system in place. However, many regulatory authorities require the application of a quality management system, such as that described in ISO 13485, to ensure that the implant achieves its intended performance and safety. NOTE 2        In this document, when not otherwise specified, the term "implant" refers to each individual component of a system or a modular implant, provided separately or as a set of components, as well as to all ancillary implants or associated implants designed for improving the intended performance.

Table of contents
  • 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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