NF EN ISO 13504

NF EN ISO 13504

October 2012
Standard Current

Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment

ISO 13504:2012 specifies general requirements for the manufacture of instruments and related accessories used in the placement of dental implants and further manipulations of connecting parts in the craniofacial area.It is applicable to single-use and reusable instruments, regardless of whether they are manually driven or connected to a power-driven system.

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Main informations

Collections

National standards and national normative documents

Publication date

October 2012

Number of pages

24 p.

Reference

NF EN ISO 13504

ICS Codes

11.060.25   Dental instruments

Classification index

S91-191

Print number

1 - 20/09/2012

International kinship

ISO 13504:2012

European kinship

EN ISO 13504:2012
Sumary
Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment

ISO 13504:2012 specifies general requirements for the manufacture of instruments and related accessories used in the placement of dental implants and further manipulations of connecting parts in the craniofacial area.

It is applicable to single-use and reusable instruments, regardless of whether they are manually driven or connected to a power-driven system.

Table of contents
  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 3.2 Instruments
    2
  • 3.3 Acier inoxydable
    2
  • 4 Classification
    3
  • 4.1 Utilisation prévue (application)
    3
  • 4.2 Contact avec les tissus
    3
  • 4.3 Retraitement
    3
  • 5 Performances prévues
    3
  • 6 Performances
    4
  • 7 Choix des matériaux
    4
  • 8 Évaluation de la performance
    4
  • 8.1 Généralités
    4
  • 8.2 Évaluation préclinique
    5
  • 8.3 Évaluation clinique
    5
  • 9 Fabrication
    5
  • 9.1 Généralités
    5
  • 9.2 Documentation technique
    5
  • 10 Retraitement
    5
  • 10.1 Produits fournis stériles
    5
  • 10.2 Produits fournis non stériles
    5
  • 10.3 Informations relatives au retraitement
    5
  • 11 Informations fournies par le fabricant
    6
  • 11.1 Généralités
    6
  • 11.2 Marquage des instruments
    6
  • 11.3 Étiquetage sur l'emballage
    6
  • 11.4 Notice d'utilisation
    6
  • Annexe A (normative) Matériaux jugés acceptables pour la fabrication des instruments
    8
  • Annexe B (informative) Correspondances des nuances d'aciers spécifiées dans les Normes internationales, régionales ou nationales
    14
  • Bibliographie
    16
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