99.60 Withdrawal effective Sep 15, 2007
CEN
CEN/TC 285 Non-active surgical implants
European Norm
11.040.40 Implants for surgery, prosthetics and orthotics
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
WITHDRAWN
EN 12010:1998
99.60
Withdrawal effective
Sep 15, 2007
WITHDRAWN
EN ISO 21534:2007