EN 12011:1998

Instrumentation to be used in association with non-active surgical implants - General requirements

Publication date:   Mar 19, 2004

General information

99.60 Withdrawal effective   Dec 3, 2008

CEN

CEN/TC 285 Non-active surgical implants

European Norm

11.040.30   Surgical instruments and materials

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Scope

This European Standard specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment. This standard applies to instruments which may be connected to powered driven systems, but does not apply to the powered driven system itself. This standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants. With regard to safety this standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

NOW

WITHDRAWN
EN 12011:1998
99.60 Withdrawal effective
Dec 3, 2008

REVISED BY

WITHDRAWN
EN ISO 16061:2008