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