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
General Information
- Status
- Withdrawn
- Publication Date
- 17-Nov-1998
- Withdrawal Date
- 05-May-2009
- 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
- 06-May-2009
- Completion Date
- 06-May-2009
Relations
- Effective Date
- 23-Mar-2009
- Effective Date
- 22-Dec-2008
- Effective Date
- 22-Dec-2008
Frequently Asked Questions
EN 12006-3:1998 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 3: Endovascular devices". This standard covers: 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.
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.
EN 12006-3:1998 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 12006-3:1998 has the following relationships with other standards: It is inter standard links to EN 12006-3:1998+A1:2009, EN 12006-3:1998/prA1; is excused to EN 12006-1:1999. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 12006-3:1998 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.
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Standards Content (Sample)
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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
...
The EN 12006-3:1998 standard provides a comprehensive framework that specifies the particular requirements for endovascular devices, crucial for ensuring safety and performance in cardiac and vascular implants. The scope of this European Standard extends beyond the basic guidelines established in EN ISO 14630 by addressing key areas such as intended performance, design attributes, materials, manufacturing processes, sterilization, packaging, and the information that should be supplied by the manufacturer. One of the strengths of this standard lies in its detailed approach to design evaluation. It not only emphasizes the safety of the endovascular devices but also highlights the importance of rigorous testing and validation. The inclusion of specific requirements regarding the materials and manufacturing processes used in these implants enhances the reliability and efficacy of the products developed under this standard. Furthermore, the acknowledgement of potential gaps in standardized in vitro tests and long-term clinical results reflects a pragmatic understanding of the evolving nature of medical technologies. While the standard recognizes the limitations existing in certain areas-particularly concerning vascular occluders, which are addressed under different regulations-it encourages manufacturers to document their validated test methods and sample preparation procedures comprehensively. This approach fosters a culture of accountability and thoroughness in the medical device industry. Additionally, the reference to current scientific literature as a guideline for design evaluation when specific standardized tests are not outlined encourages ongoing innovation and adaptation within the sector. This adaptability is vital as new scientific data becomes available, and the need for revising the standard is acknowledged as an essential component of ensuring that safety and performance requirements keep pace with advancements in technology and medical sciences. Overall, EN 12006-3:1998 stands out as a relevant and crucial standard for manufacturers of endovascular devices. It not only enhances safety protocols but also encourages continuous improvement in design and evaluation methodologies, ultimately benefiting both manufacturers and patients alike.
EN 12006-3:1998は、心臓および血管インプラントに特有の要件を定めた非アクティブ外科インプラントに関する欧州標準です。この標準は、特にエンドバスキュラー装置に関する要求事項を明確にし、製品の安全性を確保するための枠組みを提供しています。EN ISO 14630に加え、意図された性能、設計属性、材料、設計評価、製造、滅菌、包装、および製造者によって供給される情報についての要求が含まれています。 この標準の強みは、設計評価に関する指針を包括的に提供している点です。具体的に標準化された試験方法が示されていない場合でも、現在の科学的文献を参照することで、設計評価に関連するすべての側面に留意するよう製造者に促しています。この枠組みは、製品の安全性を確保するために不可欠です。 また、EN 12006-3にはインプラントの設計に関する変動が考慮されており、一部のインプラントの相対的に新しい開発のために実施可能な標準化されたin vitroテストや臨床試験の長期結果が常に利用できるわけではないことが明記されています。このように、製造者は標準で記述されていない試験方法については、検証済みの試験方法とサンプル準備手順を適切に文書化しなければなりません。 さらに科学的および臨床的データが増えるにつれ、この標準の適切な改訂が必要になることも強調されています。これにより、製品の安全性を持続的に向上させることができ、医療現場でのエンドバスキュラー装置の適用がより信頼性を増すでしょう。このように、EN 12006-3:1998は、心臓および血管インプラントの設計と安全性において、非常に重要で関連性のある標準であると言えます。
SIST EN 12006-3:2000 표준 문서에 대한 검토는 비활성 외과 임플란트와 심혈관 임플란트의 특정 요구 사항, 특히 혈관 내 장치에 중점을 두고 있습니다. 이 유럽 표준은 혈관 내 장치에 대한 특정 요구 사항을 규정하고 있으며, EN ISO 14630와 함께 안전성을 보장하는 데 필요한 성능, 디자인 속성, 재료, 설계 평가, 제조, 멸균, 포장 및 제조업체에서 제공하는 정보의 요구 사항을 제시합니다. 이 표준의 주요 강점은 제조업체가 제품 안전성에 관련된 모든 설계 평가 측면을 다루도록 보장하는 것입니다. 또한, 설계 평가는 현재의 과학 문헌을 참조하여 특정 표준화된 테스트가 설명되지 않은 경우에도 안내를 제공합니다. 이러한 점은 제조업체가 제품의 안전성을 확보하는 데 필수적인 정보를 제공받을 수 있도록 합니다. 표준의 적용 범위는 명확하며, 특정 유례가 없는 경우에는 제조업체가 사용한 검증된 테스트 방법과 샘플 준비 절차를 문서화해야 한다는 점도 강조됩니다. 또한, 최근 개발된 임플란트에 대한 표준화된 장기 임상 시험 결과가 항상 이용 가능하지 않음을 인식하고, 이는 임플란트 디자인의 다양성에 따른 것입니다. 마지막으로, 이 표준은 필요한 경우 과학적 및 임상 데이터가 추가로 제공됨에 따라 적절한 수정이 필요하다는 점을 명시하고 있어, 변화하는 기술 및 임상 환경에 지속적으로 적응할 수 있는 유연성을 보여줍니다. EN 12006-3:1998 표준은 안전하고 효과적인 심혈관 및 혈관 내 장치를 위한 중요한 기준을 제공하며, 의료 기기 산업에서의 신뢰성과 품질을 보장하는 데 기여하고 있습니다.
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