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Standards Development
This document specifies a systematic approach for the assessment of coating systems for potential use for implants. The goal of this document is to provide brief introductory guidance for a “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. ISO 17327-1 defines a set of coating properties that can be pertinent for any specific coating.
This document is intended to be a useful tool in the development of specifications and requirements
which can be used in communication, e. g. among coatings manufacturer, OEM, 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 recommend specific tests for coating systems, as it is intended as a
structure for determining important properties and tests that can be appropriate for any given
coating system.
ISO 17327-2 provides several tables listing standards related to coatings including some known test
methods.
(Please see ISO/IEC Directives, Part 1, Annex C and additional guidance on justification statements
in the brochure Guidance on New Work)
Coatings for surgical implants are widely used in the medical device industry. These coatings are
sophisticated systems involving the coating, the coating interface, and substrate(s) to the coating.
Due to this increasing complexity and variability of coating systems, tools for the consistent
assessment of their performance and suitability to their application (i. e. their service environment)
are increasingly necessary.
This technical report (TR) is intended to provide guidance for the consistent assessment of coating
systems described from design, functional, and manufacturing perspectives. (Please use this field or
attach an annex)
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