SIST EN 12006-1:2000
(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 particulieres pour les implants cardio-vasculaires - Partie 1: Protheses 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
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Frequently Asked Questions
SIST EN 12006-1:2000 is a standard published by the Slovenian Institute for Standardization (SIST). 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).
SIST EN 12006-1:2000 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.
SIST EN 12006-1:2000 has the following relationships with other standards: It is inter standard links to SIST EN ISO 5840:2006; is excused to SIST EN 12006-2:2000, SIST EN ISO 7439:2002, SIST EN 12006-3:2000. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN 12006-1:2000 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)
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
STANDARD
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The article discusses the SIST EN 12006-1:2000 standard, which outlines specific requirements for heart valve substitutes. This standard does not apply to substitutes made entirely or partially from human tissue. The standard covers aspects such as safety, intended performance, design attributes, materials, manufacturing, sterilization, packaging, and information provided by the manufacturer. It also includes test methods and requirements for determining the physical, biological, and chemical properties of the substitutes and their components. The standard recommends in vivo testing, clinical evaluation, and reporting of testing and evaluation results. Annex F provides additional rationale for the standard.
기사 제목: SIST EN 12006-1:2000 - 비활성 수술용 임플란트 - 심혈관 임플란트의 구체적 요구사항 - 제 1부: 심장 팔판 대체재 기사 내용: 이 기준은 심장 팔판 대체재에 대한 구체적인 요구사항을 명시한다. 이번 유럽 표준은 전체 또는 일부가 인체 조직으로 구성된 심장 팔판 대체재에는 적용되지 않는다. 안전성 측면에서 의도된 성능, 설계 속성, 재료, 설계 평가, 제조, 살균, 포장 및 제조업자에 의해 제공되는 정보에 대한 요구사항을 제공한다. 이 유럽 표준은 심장 팔판 대체재 및 그 구성 요소 및 재료의 물리적, 생물학적 및 화학적 특성을 결정하기 위해 사용되는 장비의 성능 특성에 대한 여러 가지 시험 방법 및 요구사항을 명시한다. 또한 이 유럽 표준에서 다양한 유형의 시험 및 평가 결과에 대한 생체 내 테스트 및 임상 평가와 결과 보고에 대한 권고사항을 제시한다. 이 권고사항은 완전한 시험 프로그램으로 간주되지 않는다(관련 근거는 부록 F 참조).
記事のタイトル：SIST EN 12006-1:2000 - 非活性外科インプラント - 心臓および血管のインプラントに関する特別要件 - 第1部：心臓弁の代替品 記事内容：この規格は、心臓弁の代替品に関する特別な要件を定めています。このヨーロッパ規格は、全体または一部が人体組織で構成されている代替品には適用されません。安全性に関しては、目的の性能、デザインの特性、材料、デザイン評価、製造、滅菌、包装および製造業者によって提供される情報に対する要件を示しています。このヨーロッパ規格は、心臓弁の代替品およびその材料および部品の物理的、生物学的、化学的特性を決定するために使用される設備の性能特性に関するテスト方法と要件を多数指定しています。また、生体内テストおよび臨床評価、およびこのヨーロッパ規格でカバーされるすべてのテストと評価結果の報告についての推奨事項も行っています。これらの推奨事項は完全なテストプログラムを含んでいるとは限りません（理由については付録Fを参照）。
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