EN 12006-3:1998
(Main)Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices
Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices
This European Standard specifies particular requirements for endovascular devices. With regard to safety, this standard gives in addition to EN ISO 14630, requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. NOTE 1: Vascular occluders are not addressed in this standard. For the time being the requirements as stated in EN ISO 14630:1997 apply for these products. NOTE 2: Due to the variations in the design of the implants covered by this standard and in some cases due to the relatively recent development of some of these implants, acceptable standardized in vitro tests and long term results of clinical trials are not always available. Where no test method is described in this standard a complete description of the validated test method and sample preparation procedure used should be documented by the manufacturer. With regard to design evaluation, where a specific standardized test is not described, guidance is given by referring to current scientific literature (see Annex A). This standard aims to ensure that manufacturers will address all aspects of design evaluation that relate to the safety of the product. As further scientific and clinical data become available, appropriate revision of the standard will be necessary.
Nichtaktive chirurgische Implantate - Besondere Anforderungen an Herz- und Gefäßimplantate - Teil 3: Endovaskuläre Implantate
Diese Europäische Norm legt Anforderungen an endovaskuläre Implantate fest. In Bezug auf die Sicherheit legt diese Norm in Ergänzung zu EN ISO 14630:1997 Anforderungen für die beabsichtigte Funktion, Konstruktionsmerkmale, Werkstoffe, Bewertung der Konstruktion, Fertigung, Sterilisation, Verpackung und die Bereitstellung von Informationen durch den Hersteller, fest.
Implants chirurgicaux non-actifs - Exigences particulières relatives aux implants cardiaques et vasculaires - Partie 3: Dispositifs endovasculaires
La présente norme européenne spécifie des exigences particulières relatives aux dispositifs endovasculaires. En ce qui concerne la sécurité, la présente norme indique en complément à la norme EN ISO 14630, des exigences relatives aux performances prévues, aux attributs de 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) - Posebne zahteve za srčnožilne vsadke (kardiovaskularni implantati) - 3. del: Znotrajžilni pripomočki
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 12006-3:2000
01-januar-2000
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Non active surgical implants - Particular requirements for cardiac and vascular implants -
Part 3: Endovascular devices
Nichtaktive chirurgische Implantate - Besondere Anforderungen an Herz- und
Gefäßimplantate - Teil 3: Endovaskuläre Implantate
Implants chirurgicaux non-act
...
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