99.60 Withdrawal effective Feb 15, 2007
CEN
CEN/TC 285 Non-active surgical implants
European Norm
11.040.40 Implants for surgery, prosthetics and orthotics
This standard describes specific requirements for mammary implants for clinical practice. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. NOTE: At the time of publication of this document for enquiry several test methods specified in the annexes were being validated. For the time being, where appropriate, disclosure statements are included in these annexes.
Legislation related to this standard
WITHDRAWN
EN 12180:2000
99.60
Withdrawal effective
Feb 15, 2007
WITHDRAWN
EN ISO 14607:2007