EN 12011:1998
(Main)Instrumentation to be used in association with non-active surgical implants - General requirements
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 être utilisée en association avec les implants chirurgicaux non actifs - Exigences générales
La présente norme européenne prescrit les exigences générales relatives aux instruments qui doivent être utilisés en association avec les implants chirurgicaux non actifs. Ces exigences s'appliquent aux instruments fournis pour la première fois ou refournis. La présente norme européenne s'applique aux instruments associés pouvant être connectés à des systèmes motorisés, mais ne s'applique pas à ces systèmes eux-mêmes. 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- Withdrawn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
- 20-Jan-1998
- Withdrawal Date
- 02-Dec-2008
- Technical Committee
- CEN/TC 285 - Non-active surgical implants
- Drafting Committee
- CEN/TC 285/WG 1 - General requirements for non active surgical implants
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 03-Dec-2008
- Completion Date
- 03-Dec-2008
- Directive
- 93/42/EEC - Medical devices
Relations
- Effective Date
- 22-Dec-2008
- Effective Date
- 22-Dec-2008
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Frequently Asked Questions
EN 12011:1998 is a standard published by the European Committee for Standardization (CEN). Its full title is "Instrumentation to be used in association with non-active surgical implants - General requirements". This standard covers: 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.
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.
EN 12011:1998 is classified under the following ICS (International Classification for Standards) categories: 11.040.30 - Surgical instruments and materials. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 12011:1998 has the following relationships with other standards: It is inter standard links to EN ISO 16061:2008; is excused to EN ISO 14630:1997. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 12011:1998 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
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Standards Content (Sample)
SLOVENSKI STANDARD
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
...
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