Non-active surgical implants — Implant coating — Part 1: General requirements

ISO 17327-1:2018 specifies general requirements for implant coatings, comprising both surface coatings and surface modifications, applied to non-active surgical implants. This document specifies requirements concerned with generic coating properties including chemical and phase compositions, surface texture, coating coverage integrity, dissolvability, coating thickness, adhesion strength, abrasion resistance, porosity and pore size, and surface wettability.

ISO 17327-1:2018 is applicable to surface coatings, which are defined as layers of material with any different property than the natural surface of the substrate which are intentionally added to the substrate.

ISO 17327-1:2018 is applicable to surface modifications, which are defined as intentional conversion or reconstruction of the surface of the original substrate to form a new surface material consisting of components of the substrate's own material and possibly foreign material and forming a surface layer with different properties.

Since the pertinent properties of a coating and their needed level of characterization are highly dependent on the intended application of the implant, the generic nature of the general requir