DIN Standards Committee Optics and Precision Mechanics
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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