NF EN ISO 16061

NF EN ISO 16061

March 2021
Standard Current

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

This document specifies the 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 supplied after refurbishment.NOTE In this document, unless otherwise specified, the term "instrument" refers to an instrument for use in association with non-active surgical implants.This document also applies to instruments which can be connected to power-driven systems, but it does not apply to the power-driven systems themselves.With regard to safety, this document gives the requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the instrument manufacturer, hereafter referred to as the manufacturer.This document is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants.

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Main informations

Collections

National standards and national normative documents

Publication date

March 2021

Number of pages

24 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

International kinship

ISO 16061:2021

European kinship

EN ISO 16061:2021
Sumary
Instruments for use in association with non-active surgical implants - General requirements

This document specifies the 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 supplied after refurbishment.

NOTE In this document, unless otherwise specified, the term "instrument" refers to an instrument for use in association with non-active surgical implants.

This document also applies to instruments which can be connected to power-driven systems, but it does not apply to the power-driven systems themselves.

With regard to safety, this document gives the requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the instrument manufacturer, hereafter referred to as the manufacturer.

This document is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants.

Replaced standards (1)
NF EN ISO 16061
July 2015
Standard Cancelled
Instrumentation for use in association with non-active surgical implants - General requirements

ISO 16061:2015 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. This International Standard 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, this International Standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the manufacturer. This International Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants, and ophthalmic implants.

Table of contents
  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Performances prévues
  • 5 Caractéristiques de conception
  • 6 Choix des matériaux
  • 7 Évaluation de la conception
  • 8 Fabrication
  • 9 Stérilisation
  • 10 Emballage
  • 11 Informations fournies par le fabricant
  • Annexe A (informative) Exemples d'applications types d'instruments à utiliser en association avec les implants chirurgicaux non actifs et de matériaux considérés comme acceptables pour fabriquer les instruments
  • Bibliographie
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