EN 12006-1:1999
(Main)Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 1: Heart valve substitutes
Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 1: Heart valve substitutes
This standard specifies particular requirements for heart valve substitutes. This European Standard is not applicable to heart valve substitutes composed in whole, or in part, of human tissue. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. This European Standard specifies a number of test methods and requirements regarding the performance characteristics of equipment to be used to determine the physical, biological and chemical properties of heart valve substitutes and of the materials and components of which they are made. Recommendations are also made for in vivo testing and clinical evaluation, and for the reporting of results of all types of testing and evaluation covered in this European Standard. These recommendations do not purport to comprise a complete test programme (see annex F for rationale).
Nichtaktive chirurgische Implantate - Besondere Anforderungen für Herz- und Gefäßimplantate - Teil 1: Herzklappenprothesen
Diese Norm legt besondere Anforderungen für Herzklappenprothesen fest. Diese Europäische Norm gilt nicht für Herzklappenprothesen, die vollständig oder teilweise aus menschlischem Gewebe bestehen. Im Hinblick auf die Sicherheit nennt sie Anforderungen für die vorgesehene Funktion, Konstruktions-merkmale, Werkstoffe, Bewertung der Konstruktion, Herstellung, Sterilisation, Verpackung und vom Hersteller zu liefernde Informationen.
Implants chirurgicaux non actifs - Exigences particulières pour les implants cardio-vasculaires - Partie 1: Prothèses valvulaires cardiaques
La présente norme européenne spécifie les exigences particulières relatives aux prothèses valvulaires cardiaques. La présente norme européenne ne s'applique pas aux prothèses valvulaires cardiaques constituées entièrement, ou en partie, de tissu d'origine humaine. En ce qui concerne la sécurité, elle présente les exigences 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) – Posebne zahteve za srčnožilne vsadke (kardiovaskularne implantate) – 1. del: Nadomestki srčne zaklopke
General Information
- Status
- Withdrawn
- Publication Date
- 20-Jul-1999
- Withdrawal Date
- 13-Dec-2005
- Technical Committee
- CEN/TC 285 - Non-active surgical implants
- Drafting Committee
- CEN/TC 285/WG 3 - Cardiac and vascular implants
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 14-Dec-2005
- Completion Date
- 14-Dec-2005
- Directive
- 93/42/EEC - Medical devices
Relations
- Effective Date
- 22-Dec-2008
- Effective Date
- 22-Dec-2008
- Effective Date
- 22-Dec-2008
- Effective Date
- 22-Dec-2008
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Frequently Asked Questions
EN 12006-1:1999 is a standard published by the European Committee for Standardization (CEN). Its full title is "Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 1: Heart valve substitutes". This standard covers: This standard specifies particular requirements for heart valve substitutes. This European Standard is not applicable to heart valve substitutes composed in whole, or in part, of human tissue. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. This European Standard specifies a number of test methods and requirements regarding the performance characteristics of equipment to be used to determine the physical, biological and chemical properties of heart valve substitutes and of the materials and components of which they are made. Recommendations are also made for in vivo testing and clinical evaluation, and for the reporting of results of all types of testing and evaluation covered in this European Standard. These recommendations do not purport to comprise a complete test programme (see annex F for rationale).
This standard specifies particular requirements for heart valve substitutes. This European Standard is not applicable to heart valve substitutes composed in whole, or in part, of human tissue. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. This European Standard specifies a number of test methods and requirements regarding the performance characteristics of equipment to be used to determine the physical, biological and chemical properties of heart valve substitutes and of the materials and components of which they are made. Recommendations are also made for in vivo testing and clinical evaluation, and for the reporting of results of all types of testing and evaluation covered in this European Standard. These recommendations do not purport to comprise a complete test programme (see annex F for rationale).
EN 12006-1:1999 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 12006-1:1999 has the following relationships with other standards: It is inter standard links to EN ISO 5840:2005; is excused to EN ISO 7439:2002, EN 12006-2:1998, EN 12006-3:1998. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 12006-1:1999 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 12006-1:1999 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)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Nichtaktive chirurgische Implantate - Besondere Anforderungen für Herz- und Gefäßimplantate - Teil 1: HerzklappenprothesenImplants chirurgicaux non actifs - Exigences particulieres pour les implants cardio-vasculaires - Partie 1: Protheses valvulaires cardiaquesNon active surgical implants - Particular requirements for cardiac and vascular implants - Part 1: Heart valve substitutes11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:Ta slovenski standard je istoveten z:EN 12006-1:1999SIST EN 12006-1:2000en01-julij-2000SIST EN 12006-1:2000SLOVENSKI
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