NF EN ISO 16061

NF EN ISO 16061

February 2009
Standard Cancelled

Instrumentation for use in association with non-active surgical implants - General requirements

ISO 16061:2008 specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment.ISO 16061:2008 also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves.With regard to safety, ISO 16061:2008 gives requirements for intended performance, design attributes, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be supplied by the manufacturer.

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Main informations

Collections

National standards and national normative documents

Publication date

February 2009

Number of pages

27 p.

Reference

NF EN ISO 16061

ICS Codes

11.040.30   Surgical instruments and materials
11.040.40   Implants for surgery, prosthetics and orthotics

Classification index

S94-002

Print number

1 - 23/01/2009

International kinship

ISO 16061:2008

European kinship

EN ISO 16061:2008
Sumary
Instrumentation for use in association with non-active surgical implants - General requirements

ISO 16061:2008 specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment.

ISO 16061:2008 also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves.

With regard to safety, ISO 16061:2008 gives requirements for intended performance, design attributes, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be supplied by the manufacturer.

Replaced standards (1)
NF EN 12011
April 1998
Standard Cancelled
Instrumentation to be used in association with non-active surgical implants. General requirements

Le présent document fixe les exigences générales relatives aux instruments qui doivent être utilisés en association avec les implants chirurgicaux non actifs. Ces exigences s'appliquent aux instruments fournis pour la première fois ou refournis.

Standard replaced by (1)
NF EN ISO 16061
November 2009
Standard Cancelled
Instrumentation for use in association with non-active surgical implants - General requirements

ISO 16061:2008 specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment. ISO 16061:2008 also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves. With regard to safety, ISO 16061:2008 gives requirements for intended performance, design attributes, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be supplied by the manufacturer.

Table of contents
  • Avant-propos
    iv
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Performances prévues
    2
  • 5 Caractéristiques de conception
    3
  • 6 Choix des matériaux
    3
  • 7 Évaluation de la conception
    4
  • 7.1 Généralités
    4
  • 7.2 Évaluation préclinique
    4
  • 7.3 Évaluation clinique
    4
  • 8 Fabrication
    4
  • 9 Stérilisation
    4
  • 9.1 Produits fournis à l'état stérile
    4
  • 9.2 Produits fournis à l'état non stérile
    4
  • 10 Emballage
    5
  • 10.1 Protection contre les dommages au cours du stockage et du transport
    5
  • 10.2 Maintien de la stérilité pendant le transport
    5
  • 11 Informations à fournir par le fabricant
    5
  • 11.1 Généralités
    5
  • 11.2 Instruments ayant une fonction de mesure
    5
  • 11.3 Restrictions relatives aux combinaisons
    5
  • 11.4 Marquage des instruments
    5
  • 11.5 Notice d'instructions
    6
  • 11.6 Instruments à usage unique
    6
  • Annexe A (informative) Exemples d'un certain nombre d'applications et de matériaux constitutifs d'instruments jugés satisfaisants
    7
  • Bibliographie
    18
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