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.

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Main informations

Collections

National standards and national normative documents

Publication date

April 1998

Number of pages

23 p.

Reference

NF EN 12011

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 - 10/10/2005

European kinship

EN 12011:1998

Sumary

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

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.

Table of contents

Avant-propos
3
0 Introduction
4
1 Domaine d'application
4
2 Références normatives
4
3 Définitions
5
4 Performances prévues
5
5 Conception
5
6 Matériaux
6
7 Évaluation de la conception
6
8 Fabrication
6
9 Stérilisation
7
10 Emballage
7
11 Informations fournies par le fabricant
7
Annexe A (informative) Bibliographie
9
Annexe B (informative) Liste d'un certain nombre d'applications et de matériaux constitutifs d'instruments jugés satisfaisants
11
Annexe C (informative) Articles de la présente norme européenne concernant les exigences essentielles ou d'autres dispositions des Directives UE
21

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