Norm

ISO/DIS 17327-1:2017 en

Non-active surgical implants - Implant coating - Part 1: General requirements

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Over deze norm

Status Ontwerp
Aantal pagina's 16
Commissie Chirurgische implantaten
Gepubliceerd op 11-02-2017
Taal Engels
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 substrateĀ“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 non-hazardous 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.

Details

ICS-code 11.040.40
Nederlandse titel Non-active surgical implants - Implant coating - Part 1: General requirements
Engelse titel Non-active surgical implants - Implant coating - Part 1: General requirements

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