NA 027

DIN Standards Committee Optics and Precision Mechanics

Standards [Withdrawn]

DIN EN ISO 16061
Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015); German version EN ISO 16061:2015

Title (German)

Instrumente, die in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet werden - Allgemeine Anforderungen (ISO 16061:2015); Deutsche Fassung EN ISO 16061:2015

Overview

This standard 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 document 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 document is not applicable to instruments associated with dental implants, transendodontic and transradicular implants, and ophthalmic implants. The committee responsible for this standard is NA 027-02-17 AA "Chirurgische Implantate" ("Implants for surgery") at DIN.

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 027-05-02 AA - Comprehensive aspects for implants for surgery  

Responsible european committee

CEN/TC 285 - Non-active surgical implants  

Edition 2015-09
Original language German
Translation English
Price from 91.80 €
Table of contents

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