NA 176

DIN Standards Committee Health Technologies

Standards [CURRENT]

DIN EN ISO 14630
Non-active surgical implants - General requirements (ISO 14630:2012); German version EN ISO 14630:2012

Title (German)

Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO 14630:2012); Deutsche Fassung EN ISO 14630:2012

Overview

This document specifies general requirements for non-active surgical implants. It is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants and intra-ocular lenses. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements. The modifications include the extension of clause "Design attributes" to include, for example, anatomical features, the extension of clause "Pre-clinical evaluation" by modeling as well as the inclusion of a date of the latest revision of the instructions for use. Furthermore, Annex ZA has been brought in line with the requirements of the EU Commission. The responsible German committee is Working Committee is NA 027-02-17 AA "Chirurgische Implantate" ("Implants for surgery") at the Optics and Precision Mechanics Standards Committee (NAFuO) 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  

Responsible international committee

ISO/TC 150/WG 7 - Fundamental standards  

Edition 2013-03
Original language German
Translation English
Price from 85.30 €
Table of contents

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