Information service
11.040.40 Implants for surgery, prosthetics and orthotics
New standards
ISO/TR 4234:2026
Non-active surgical implants — Implant coating — Best practices for coating system assessment
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.
NOTE 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 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.
NOTE ISO/TR 17327-2 provides several tables listing standards related to coatings including some known test methods.
NOTE 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 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.
NOTE ISO/TR 17327-2 provides several tables listing standards related to coatings including some known test methods.
Base documents:
Replaced standards
Drafts
prEN ISO 22523
External limb prostheses and external orthoses - Requirements and test methods (ISO/DIS 22523:2026)
Scope: This document specifies requirements and test methods for external limb prostheses and external orthoses,
including the following classifications from ISO 9999:
06 03 to 06 15 Orthoses
06 18 to 06 24 Limb prostheses
This document covers strength, materials, restrictions on use, risk and the provision of information
associated with the normal conditions of use of both components and assemblies of components. This
document is also applicable as guidance in the design and test of custom build orthosis and prosthesis.
NOTE The use of quality systems as described or referred to in ISO 13485 and ISO 13488 can be appropriate.
including the following classifications from ISO 9999:
06 03 to 06 15 Orthoses
06 18 to 06 24 Limb prostheses
This document covers strength, materials, restrictions on use, risk and the provision of information
associated with the normal conditions of use of both components and assemblies of components. This
document is also applicable as guidance in the design and test of custom build orthosis and prosthesis.
NOTE The use of quality systems as described or referred to in ISO 13485 and ISO 13488 can be appropriate.
Base documents: prEN ISO 22523; ISO/DIS 22523:2026