ISO DIS 17327-1

Description / Abstract: This part of ISO 17327 specifies general requirements for implant coatings, comprising both surface coatings and surface modifications, applied to non-active surgical implants. This International Standard specifies requirements concerned with generic coating properties.

This International Standard is applicable to surface coatings, i. e. layers of material with any different property than the natural surface of the substrate which are intentionally added to the substrate.

This International Standard is applicable to surface modifications, i. e. intentionally converted or reconstructed surfaces of the original substrate to form a new material consisting of components of the substrate´s own material and foreign material and forming a surface layer with different properties.

This International Standard is not applicable to surfaces modified by texturing with the exclusive intention to change the roughness of the surface or the strength of the raw material.

This International Standard is not applicable to natively passivated metal surfaces. While this International Standard is applicable to intentionally passivated metal surfaces, well-established materials passivated by conventional techniques, such as nitric acid immersion, are usually nonhazardous and can be described in a very basic manner.

This International Standard is not applicable to implant coatings utilizing viable tissue.

This International Standard is not applicable to laminates, i. e. composite materials made of multiple layers, e. g. vascular prosthesis constructed of different expanded polytetrafluoroethylene layers.

This International Standard is not applicable to coverings, e. g. covered stents.

NOTE 1 This International Standard does not contain requirements on biocompatibility. Nevertheless, this is a critical property of the device and coating and needs to be addressed during risk assessment.

NOTE 2 This International Standard supplements applicable non-active surgical implant standards and ISO 14630.

NOTE 3 This International Standard does not require that manufacturers have a quality management system in place. However, the application of a quality management system, such as that described in ISO 13485, could be appropriate to help ensure that the implant achieves its intended performance.

NOTE 4 Although fully porous implants are not coatings, some of the considerations in this document can also be applied to them.