ISO 17327-1 Inactive Surgical Implants - Test for Implant Coating

Medical Tests

ISO 17327-1 Inactive Surgical Implants - Test for Implant Coating

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 17327-1 testing. This standard specifies general requirements for implant coatings, which include both surface coatings and surface modifications applied to inactive surgical implants.

ISO 17327-1 Inactive Surgical Implants - Test for Implant Coating

This standard specifies requirements for general coating properties, including chemical and phase compositions, surface texture, coating coating integrity, solubility, coating thickness, adhesion strength, abrasion resistance, porosity and pore size, and surface wettability.

ISO 17327-1 is applicable to surface coatings, defined as layers of material with properties different from the natural surface of the substrate that are deliberately added to the substrate.

ISO 17327-1 is applicable to surface modifications, defined as the deliberate transformation or restructuring 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 to form a surface layer. have different features.

The general nature of the general requirements in this document are not intended to supersede or supersede the provisions of application-specific performance standards, as the relevant properties of a coating and the level of characterization required of them are highly dependent on the intended application of the implant. .

ISO 17327-1 cannot be applied to surfaces that have been modified by texturing only to change the roughness of the surface or the strength of the raw material.

ISO 17327-1 cannot be applied to naturally passivated metal surfaces. While this document is applicable to intentionally passivated metal surfaces, rooted materials passivated by conventional techniques such as nitric acid dipping are generally not hazardous and can be described very simply.

ISO 17327-1 is not applicable to laminates, i.e. composite materials consisting of multiple layers, for example vascular prostheses made of different expanded polytetrafluoroethylene layers, except for the exposed surface of the laminate, which may be an implant coating.

ISO 17327-1 cannot be applied to coatings such as draped stents. ISO 17327-1 does not include biocompatibility requirements. However, this is a critical feature of the device and coating and must be addressed during risk assessment. While fully porous implants are not veneered, some of the considerations in this document can be applied to them as well.

EUROLAB assists manufacturers with ISO 17327-1 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.

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