NF EN ISO 14630

NF EN ISO 14630

March 1998
Standard Cancelled

Non-active surgical implants. General requirements.

Main informations

Collections

National standards and national normative documents

Publication date

March 1998

Number of pages

16 p.

Reference

NF EN ISO 14630

ICS Codes

11.040.40   Implants for surgery, prosthetics and orthotics

Classification index

S94-001

Print number

1 - 04/10/2005

International kinship

ISO 14630:1997

European kinship

EN ISO 14630:1997
Standard replaced by (1)
NF EN ISO 14630
November 2005
Standard Cancelled
Non-active surgical implants - General requirements

ISO 14630:2005 specifies general requirements for non-active surgical implants, hereafter referred to as implants. It is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants and intra-ocular lenses. With regard to safety, ISO 14630:2005 gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests required to demonstrate compliance with these requirements. Additional tests are given or referred to in Level 2 and Level 3 Standards.

Table of contents
  • Avant-propos
    3
  • Introduction
    4
  • 1 Domaine d'application
    4
  • 2 Références normatives
    4
  • 3 Définitions
    5
  • 4 Performances prévues
    6
  • 5 Conception
    6
  • 6 Matériaux
    7
  • 7 Évaluation de la conception
    7
  • 8 Fabrication
    8
  • 9 Stérilisation
    8
  • 10 Emballage
    9
  • 11 Informations fournies par le fabricant
    9
  • Annexe A (informative) Bibliographie
    10
  • Annexe B (informative) Articles de la présente norme européenne concernant les exigences essentielles ou d'autres dispositions des Directives UE
    13
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