ISO/NP 27132

Non-active surgical implants — General requirements for personalized surgical implants

Scope

This document specifies general requirements for non-active personalized surgical implants, hereinafter referred to as personalized implants, and their accessoires and instrumentation. This document does not apply to dental implants, dental restorative materials, trans endodontic and trans radicular implants, intraocular lenses, and implants utilizing viable tissues.

This document specifies requirements for intended function, design features, personalized design process, materials, design verification, process validation, manufacturing, cleaning, packaging, sterilization, clinical evaluation, post market surveillance and provision of information by the manufacturer, as well as test methods to demonstrate compliance with these requirements.