UNE-EN ISO 14630:2025

This document specifies general requirements for non-active surgical implants, hereafter referredto as implants. This document is not applicable to dental implants, dental restorative materials,transendodontic and transradicular implants, intra-ocular lenses, the viable animal or human tissuecomponents of implants containing viable animal or human tissue and implants intended to remain inplace for less than 30 days after being implanted.With regard to safety, this document specifies requirements for intended performance, designattributes, materials, design evaluation, manufacture, sterilization, packaging and information suppliedby the manufacturer, and tests to demonstrate compliance with these requirements.Additional requirements applicable to specific implants or implant families are given or referred to inLevel 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 thatdescribed 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 individualcomponent of a system or a modular implant, provided separately or as a set of components, as well as to allancillary implants or associated implants designed for improving the intended performance.