EN ISO 14630:1997
(Main)Non-active surgical implants - General requirements (ISO 14630:1997)
Non-active surgical implants - General requirements (ISO 14630:1997)
This European Standard specifies general requirements for non-active surgical implants. This standard is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants and intra-ocular lenses. 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, and tests. Tests required to be used to demonstrate compliance with this standard are contained in other levels.
Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO 14630:1997)
Diese Europäische Norm legt allgemeine Anforderungen für nichtaktive chirurgische Implantate fest. Diese Norm gilt nicht für Dentalimplantate, transendodontische und transradikuläre Implantate sowie Intraokularlinsen. In Bezug auf die Sicherheit legt diese Norm Anforderungen für die beabsichtigte Funktion, Konstruktionsmerkmale, Werkstoffe, Designprüfung, Herstellung, Sterilisation, Verpackung und die Bereitstellung von Informationen durch den Hersteller sowie Prüfverfahren fest.
Implants chirurgicaux non actifs - Exigences générales (ISO 14630:1997)
La présente norme européenne spécifie les exigences générales relatives aux implants chirurgicaux non actifs. Elle ne s'applique ni aux implants dentaires, ni aux produits utilisés en médecine dentaire restauratrice, ni aux implants transendodontiques et transradiculaires et ne concerne pas non plus verres intraoculaires.
Neaktivni kirurški vsadki (implantati) - Splošne zahteve (ISO 14630:1997)
General Information
- Status
- Withdrawn
- Publication Date
- 31-Oct-1997
- Withdrawal Date
- 30-Apr-2005
- 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
- 01-May-2005
- Completion Date
- 01-May-2005
- Directive
- 93/42/EEC - Medical devices
Relations
- Effective Date
- 22-Dec-2008
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 22-Dec-2008
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Frequently Asked Questions
EN ISO 14630:1997 is a standard published by the European Committee for Standardization (CEN). Its full title is "Non-active surgical implants - General requirements (ISO 14630:1997)". This standard covers: This European Standard specifies general requirements for non-active surgical implants. This standard is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants and intra-ocular lenses. 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, and tests. Tests required to be used to demonstrate compliance with this standard are contained in other levels.
This European Standard specifies general requirements for non-active surgical implants. This standard is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants and intra-ocular lenses. 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, and tests. Tests required to be used to demonstrate compliance with this standard are contained in other levels.
EN ISO 14630:1997 is classified under the following ICS (International Classification for Standards) categories: 11.040.40 - Implants for surgery, prosthetics and orthotics. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 14630:1997 has the following relationships with other standards: It is inter standard links to EN ISO 14630:2005, CEN/TS 15277:2006, EN 12006-2:1998+A1:2009, EN 81-2:1998+A3:2009, EN 81-1:1998+A3:2009; is excused to EN 12011:1998. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 14630:1997 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.
EN ISO 14630:1997 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2000
Neaktivni kirurški vsadki (implantati) - Splošne zahteve (ISO 14630:1997)
Non-active surgical implants - General requirements (ISO 14630:1997)
Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO 14630:1997)
Implants chirurgicaux non actifs - Exigences générales (ISO 14630:1997)
Ta slovenski standard je istoveten z: EN ISO 14630:1997
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
SIST EN ISO 14630:20
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