EN ISO 14602:1998
(Main)Non-active surgical implants - Implants for Osteosynthesis - Particular requirements (ISO 14602:1998)
Non-active surgical implants - Implants for Osteosynthesis - Particular requirements (ISO 14602:1998)
This European standard specifies particular requirements for non-active surgical implants for osteosynthesis, hereafter referred to as implants. In addition to EN ISO 14630:1997, this standard gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information supplied by the manufacturer.
Nichtaktive chirurgische Implantate - Implantate zur Osteosynthese - Besondere Anforderungen (ISO 14602:1998)
Diese Norm legt besondere Anforderungen für nichtaktive chirurgische Implantate zur Osteosynthese fest, die nachstehend als Implantate bezeichnet werden. Zusätzlich zur prEN 14630:1995 enthält diese Norm besondere Anforderungen für die beabsichtigte Funktion, Konstruktionsmerkmale, Werkstoffe, Designprüfung, Herstellung, Sterilisation, Verpackung und die Bereitstellung von Informationen durch den Hersteller.
Implants chirurgicaux non actifs - Implants pour ostéosynthèse - Exigences particulières (ISO 14602:1998)
La présente norme européenne prescrit les exigences particulières relatives aux implants chirurgicaux non actifs pour ostéosynthèse, appelés ci-après "implants". En complément au prEN 14630:1995,la présente norme européenne fournit des exigences particulières relatives aux performances prévues, à la conception, aux matériaux, à l'évaluation de la conception, à la fabrication, à la stérilisation, à l'emballage et aux informations fournies par le fabricant.
Neaktivni kirurški vsadki (implantati) - Vsadki za osteosintezo - Posebne zahteve (ISO 14602:1998)
General Information
- Status
- Withdrawn
- Publication Date
- 14-May-1998
- Withdrawal Date
- 12-May-2009
- Technical Committee
- CEN/TC 285 - Non-active surgical implants
- Drafting Committee
- CEN/TC 285/WG 5 - Osteosynthesis
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 13-May-2009
- Completion Date
- 13-May-2009
- Directive
- 93/42/EEC - Medical devices
Relations
- Effective Date
- 22-Dec-2008
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Frequently Asked Questions
EN ISO 14602:1998 is a standard published by the European Committee for Standardization (CEN). Its full title is "Non-active surgical implants - Implants for Osteosynthesis - Particular requirements (ISO 14602:1998)". This standard covers: This European standard specifies particular requirements for non-active surgical implants for osteosynthesis, hereafter referred to as implants. In addition to EN ISO 14630:1997, this standard gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information supplied by the manufacturer.
This European standard specifies particular requirements for non-active surgical implants for osteosynthesis, hereafter referred to as implants. In addition to EN ISO 14630:1997, this standard gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information supplied by the manufacturer.
EN ISO 14602:1998 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 14602:1998 has the following relationships with other standards: It is inter standard links to EN ISO 14602:2009. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 14602:1998 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.
EN ISO 14602:1998 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) - Vsadki za osteosintezo - Posebne zahteve
(ISO 14602:1998)
Non-active surgical implants - Implants for Osteosynthesis - Particular requirements (ISO
14602:1998)
Nichtaktive chirurgische Implantate - Implantate zur Osteosynthese - Besondere
Anforderungen (ISO 14602:1998)
Implants chirurgicaux non actifs - Implants pou
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