SSH EN 12010:2000

Implantet kirurgjikale jo aktive - Implantet zëvendësese të bashkimit - Kërkesa të veçanta

Non-active surgical implants - Joint replacement implants - Particular requirements

Scope

This European Standard specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, hereafter referred to as implants. For the purposes of this standard, artificial ligaments and their associated fixing devices are included in the term implant, hereinafter referred to as implants. It specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer. Some tests required to demonstrate compliance with this standard are contained in or referenced in level 3 standards.

Related directives

Directives related to this standards.