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.

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Main informations

Collections

National standards and national normative documents

Publication date

November 2005

Number of pages

29 p.

Reference

NF EN ISO 14630

ICS Codes

11.040.40 Implants for surgery, prosthetics and orthotics

Classification index

S94-001

Print number

1 - 17/11/2005

International kinship

ISO 14630:2005

European kinship

EN ISO 14630:2005

Sumary

Non-active surgical implants - General requirements

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.

Replaced standards (1)

NF EN ISO 14630

March 1998

Standard Cancelled

Non-active surgical implants. General requirements.

Standard replaced by (1)

NF EN ISO 14630

November 2008

Standard Cancelled

Non-active surgical implants - General requirements

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. 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.

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
5
7.4 Surveillance postmarketing
5
8 Fabrication
6
9 Stérilisation
6
9.1 Généralités
6
9.2 Produits fournis à l'état stérile
6
9.3 Stérilisation par l'utilisateur
6
9.4 Résidus de stérilisation
7
10 Emballage
7
10.1 Protection contre les dommages au cours du stockage et du transport
7
10.2 Maintien de la stérilité pendant le transport
7
11 Informations fournies par le fabricant
7
11.1 Généralités
7
11.2 Étiquetage
8
11.3 Instructions d'utilisation
9
11.4 Restrictions relatives aux combinaisons
10
11.5 Marquage des implants
10
11.6 Marquage pour utilisations spéciales
10
Annexe A (informative) Correspondance entre les articles de la présente Norme Internationale et les principes fondamentaux exposés dans l'ISO/TR 14283:2004
11
Bibliographie
12

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