NF EN ISO 14602

NF EN ISO 14602

April 2012
Standard Current

Non-active surgical implants - Implants for osteosynthesis - Particular requirements

ISO 14602:2010 specifies particular requirements for non-active surgical Implants for osteosynthesis, referred to as implants. In addition to ISO 14630, ISO 14602:2010 gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.

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Main informations

Collections

National standards and national normative documents

Publication date

April 2012

Number of pages

23 p.

Reference

NF EN ISO 14602

ICS Codes

11.040.40   Implants for surgery, prosthetics and orthotics

Classification index

S94-101

Print number

1 - 19/03/2012

International kinship

ISO 14602:2010

European kinship

EN ISO 14602:2011
Sumary
Non-active surgical implants - Implants for osteosynthesis - Particular requirements

ISO 14602:2010 specifies particular requirements for non-active surgical Implants for osteosynthesis, referred to as implants.

In addition to ISO 14630, ISO 14602:2010 gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.

Replaced standards (1)
NF EN ISO 14602
July 2010
Standard Cancelled
Non-active surgical implants - Implants for osteosynthesis - Particular requirements

<p>ISO 14602:2010 specifies particular requirements for non-active surgical Implants for osteosynthesis, referred to as implants.</p> <p>In addition to ISO 14630, ISO 14602:2010 gives particular 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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  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    1
  • 4 Performances prévues
    1
  • 4.1 Généralités
    1
  • 4.2 Objectif recherché
    2
  • 4.3 Caractéristiques fonctionnelles
    2
  • 4.4 Conditions d'utilisation prévues
    3
  • 5 Caractéristiques de conception
    3
  • 6 Matériaux
    4
  • 7 Évaluation de la conception
    4
  • 7.1 Généralités
    4
  • 7.2 Évaluation préclinique
    4
  • 7.3 Évaluation clinique
    4
  • 7.4 Surveillance après commercialisation
    4
  • 8 Fabrication
    5
  • 9 Stérilisation
    5
  • 10 Emballage
    5
  • 11 Informations fournies par le fabricant
    5
  • 11.1 Généralités
    5
  • 11.2 Étiquetage
    5
  • 11.3 Instructions d'utilisation
    5
  • 11.4 Restrictions relatives aux combinaisons
    5
  • 11.5 Marquage des implants
    5
  • 11.6 Marquage pour utilisations spéciales
    5
  • Annexe A (informative) Correspondance entre les articles de la présente Norme internationale et les principes fondamentaux énoncés dans l'ISO/TR 14283
    6
  • Annexe B (informative) Normes internationales ISO se référant aux implants et instruments associés jugés acceptables sur la base de leur utilisation clinique dans le cadre de certaines applications en ostéosynthèse
    7
  • Annexe C (informative) Normes internationales relatives aux matériaux jugés acceptables sur la base d'une utilisation clinique éprouvée
    10
  • Annexe D (informative) Normes relatives aux essais et à l'évaluation de la conception
    12
  • Bibliographie
    13
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