EN 12010:1998

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

Publication date:   Mar 19, 2004

General information

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

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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 legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

NOW

WITHDRAWN
EN 12010:1998
99.60 Withdrawal effective
Sep 15, 2007

REVISED BY

WITHDRAWN
EN ISO 21534:2007