NA 027

DIN Standards Committee Optics and Precision Mechanics

Project

Non-active surgical implants - General requirements (ISO/FDIS 14630:2024); German version FprEN ISO 14630:2024

Abstract

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 gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests required to demonstrate compliance with these requirements.

Begin

2018-10-09

WI

00285132

Planned document number

DIN EN ISO 14630

Project number

02703185

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  

draft standard

Non-active surgical implants - General requirements (ISO/DIS 14630:2022); German and English version prEN ISO 14630:2022
2022-10
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previous edition(s)

Non-active surgical implants - General requirements (ISO 14630:2012); German version EN ISO 14630:2012
2013-03

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Contact

Klaus Zeier

Alexander-Wellendorff-Str. 2
75172 Pforzheim

Tel.: +49 7231 9188-15
Fax: +49 7231 9188-33

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