1 Scope

This document specifies a systematic approach for the development of an assessment plan for coating systems for potential use for implants. This document provides brief introductory guidance on the coating system and intended functions. This document describes the assessment process from the context of product design, manufacturing (including sterilization), product aging and clinical intended use. This assessment process is intended to help evaluate coating properties that are pertinent to the performance of the coated devices and uses relevant examples to illustrate the process.

This document is intended to be a useful tool in the development of an assessment plan of coating systems and is meant to support communication, e.g. among coatings manufacturer, original equipment manufacturer and regulatory bodies (through direct interaction or master files).

This document does not address the clinical safety and performance of the surgical implant for which the coating system is a part.

This document also does not cover specific tests for coating systems, as it is intended to be a structure for determining important properties and tests that can be appropriate for any given coating system.