SIST EN 12011:2000

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

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.

Instrumente die in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet werden - Allgemeine Anforderungen

Diese Norm legt allgemeine Anforderungen für Instrumente, die in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet werden fest. Diese Anforderungen gelten auch für Instrumente, die erstmals als auch wiedergeliefert werden. Diese Norm gilt nicht für Instrumente, die in Verbindung mit Dentalimplantaten, transendodontischen und transradikulären Implantaten sowie ophthalmologischen Implantaten verwendet werden.

L'instrumentation devant etre utilisée en association avec les implants chirurgicaux non actifs - Exigences générales

La présente norme européenne prescrit les exigences générales relatives aux instruments qui doivent etre utilisés en association avec les implants chirurgicaux non actifs. Ces exigences s'appliquent aux instruments fournis pour la premiere fois ou refournis. La présente norme européenne s'applique aux instruments associés pouvant etre connectés a des systemes motorisés, mais ne s'applique pas a ces systemes eux-memes. La présente norme ne s'applique pas aux instruments associés aux implants dentaires, aux implants transendodontiques et transradiculaires, et aux implants ophtalmiques.

Instrumenti, ki se uporabljajo pri neaktivnih kirurških vsadkih (implantati) - Splošne zahteve

General Information

• Status: Withdrawn
• Publication Date: 31-Dec-1999
• Withdrawal Date: 11-Jan-2009
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 09-Jan-2009
• Due Date: 01-Feb-2009
• Completion Date: 12-Jan-2009
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN 12011:1998 - Instrumentation to be used in association with non-active surgical implants - General requirements

Relations

• Parent: SIST EN ISO 14630:2000 - Non-active surgical implants - General requirements (ISO 14630:1997)
• Effective Date: 22-Dec-2008
• Replaced By: SIST EN ISO 16061:2009 - Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008)
• Effective Date: 01-Mar-2009

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 12011:2000
01-januar-2000
Instrumenti, ki se uporabljajo pri neaktivnih kirurških vsadkih (implantati) -
Splošne zahteve
Instrumentation to be used in association with non-active surgical implants - General
requirements
Instrumente die in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet
werden - Allgemeine Anforderungen
L'instrumentation devant etre utilisée
...