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