NF EN ISO 22794

NF EN ISO 22794

May 2009
Standard Cancelled

Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file

ISO 22794:2007 applies to implantable materials, whether resorbable or non-resorbable, used as dental devices for filling and augmenting bones in oral and maxillofacial surgery. Products that are essentially pure (greater than 90 %) hydroxyapatite are not covered by this International Standard.Evaluation includes the physico-chemical, mechanical, biological and clinical aspects and behaviour of these implantable dental materials.

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Main informations

Collections

National standards and national normative documents

Publication date

May 2009

Number of pages

18 p.

Reference

NF EN ISO 22794

ICS Codes

11.060.15   Dental implants
11.100.20   Biological evaluation of medical devices

Classification index

S91-155

Print number

1 - 08/06/2009

International kinship

ISO 22794:2007

European kinship

EN ISO 22794:2007
Sumary
Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file

ISO 22794:2007 applies to implantable materials, whether resorbable or non-resorbable, used as dental devices for filling and augmenting bones in oral and maxillofacial surgery. Products that are essentially pure (greater than 90 %) hydroxyapatite are not covered by this International Standard.

Evaluation includes the physico-chemical, mechanical, biological and clinical aspects and behaviour of these implantable dental materials.

Replaced standards (1)
NF S91-155
November 1995
Standard Cancelled
Implantation materials for bone reconstruction (packing, augmentation and regeneration) in oral and maxillofacial surgery. State of the art. Catalogue of materials. Methods of evaluation.

Le présent document fixe une classification et définit une méthodologie pour caractériser et évaluer la biocompatibilité et la biofonctionnalité des matériaux de reconstruction osseuse utilisés en chirurgie bucco-dentaire et/ou maxillo-faciale.

Standard replaced by (1)
NF EN ISO 22794
December 2009
Standard Current
Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file

ISO 22794:2007 applies to implantable materials, whether resorbable or non-resorbable, used as dental devices for filling and augmenting bones in oral and maxillofacial surgery. Products that are essentially pure (greater than 90 %) hydroxyapatite are not covered by this International Standard. Evaluation includes the physico-chemical, mechanical, biological and clinical aspects and behaviour of these implantable dental materials.

Table of contents
  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Matériaux implantables
    3
  • 5 Dossier technique
    3
  • 5.1 Contenu
    3
  • 5.2 Composition chimique
    3
  • 5.3 Propriétés physiques
    4
  • 5.4 Applications prévues, précautions, avertissements et instructions
    4
  • 5.5 Évaluation préclinique et clinique
    5
  • 5.6 Fabrication
    7
  • 5.7 Matériaux d'origine animale
    7
  • 5.8 Stérilisation
    7
  • 5.9 Emballage
    7
  • 5.10 Informations complémentaires fournies par le fabricant
    8
  • Bibliographie
    9
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