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.
Legislation related to this standard
ABANDON
prEN 12010:1998 rev
30.98
Project deleted
Mar 6, 2001
