DIN Standards Committee Optics and Precision Mechanics
Non-active surgical implants - General requirements (ISO/FDIS 14630:2024)
Abstract
This document specifies general requirements for non-active surgical implants, hereafter referred to as implants. This document is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal or human tissue. 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. Additional requirements applicable to specific implants or implant families are given or referred to in Level 2 and Level 3 standards. NOTE 1 This document does not require that the manufacturer have a quality management system in place. However, many regulatory authorities require the application of a quality management system, such as that described in ISO 13485, to ensure that the implant achieves its intended performance and safety. NOTE 2 In this document, when not otherwise specified, the term "implant" refers to each individual component of a system or a modular implant, provided separately or as a set of components, as well as to all ancillary implants or associated implants designed for improving the intended performance.
Begin
2018-10-01
WI
00285132
Planned document number
FprEN ISO 14630
Responsible national committee
NA 027-05-02 AA - Comprehensive aspects for implants for surgery
Responsible european committee
CEN/TC 285 - Non-active surgical implants
draft standard
Non-active surgical implants - General requirements (ISO/FDIS 14630:2024)
2024-04
Order from DIN Media
previous edition(s)
Non-active surgical implants - General requirements (ISO 14630:2012)
2012-12
