EN 1615:2000
(Main)Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing
Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing
This European Standard specifies requirements for the design and testing of sin gle-use enteral feeding catheters, single-use enteral giving sets and their connection systems. Requirements for radiodetectable enteral feeding cathetersare not given in this standard. NOTE Enteral feeding catheters intended for insertion through the mouth or nose can be radiodetectable in their entirety or atthe tip or by means of intermittent marks. At present there is no generally accepted standard test method for radiodetectability, but research to develop a standard method of test is being considered.
Katheter und Überleitungsgeräte zur enteralen Ernährung und ihre Konnektoren zur einmaligen Verwendung - Ausführung und Prüfung
Diese Europäische Norm legt Anforderungen an die Ausführung und Prüfung von Kathetern und Überleitungsgeräten zur enteralen Ernährung zur einmaligen Verwendung und ihre Verbindungssysteme fest. Anforderungen an die Röntgenkontrastfähigkeit sind in dieser Norm nicht enthalten.
Sondes et dispositifs de nutrition entérale non réutilisables et leurs raccords - Conception et essais
La présente Norme européenne spécifie des exigences de conception et des essais relatifs aux sondes et aux dispositifs de nutrition entérale non réutilisables, et à leurs systèmes de raccordement.
Enteralni katetri za hranjenje in kompleti za hranjenje za enkratno uporabo ter njihovi priključki - Načrtovanje in preskušanje
General Information
- Status
- Withdrawn
- Publication Date
- 17-Oct-2000
- Withdrawal Date
- 13-Apr-2025
- Technical Committee
- CEN/TC 205 - Non-active medical devices
- Drafting Committee
- CEN/TC 205/WG 6 - Catheters and enteral feeding tubes
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 08-Apr-2020
- Completion Date
- 14-Apr-2025
Relations
- Effective Date
- 22-Dec-2008
- Effective Date
- 15-Apr-2020
Frequently Asked Questions
EN 1615:2000 is a standard published by the European Committee for Standardization (CEN). Its full title is "Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing". This standard covers: This European Standard specifies requirements for the design and testing of sin gle-use enteral feeding catheters, single-use enteral giving sets and their connection systems. Requirements for radiodetectable enteral feeding cathetersare not given in this standard. NOTE Enteral feeding catheters intended for insertion through the mouth or nose can be radiodetectable in their entirety or atthe tip or by means of intermittent marks. At present there is no generally accepted standard test method for radiodetectability, but research to develop a standard method of test is being considered.
This European Standard specifies requirements for the design and testing of sin gle-use enteral feeding catheters, single-use enteral giving sets and their connection systems. Requirements for radiodetectable enteral feeding cathetersare not given in this standard. NOTE Enteral feeding catheters intended for insertion through the mouth or nose can be radiodetectable in their entirety or atthe tip or by means of intermittent marks. At present there is no generally accepted standard test method for radiodetectability, but research to develop a standard method of test is being considered.
EN 1615:2000 is classified under the following ICS (International Classification for Standards) categories: 11.040.20 - Transfusion, infusion and injection equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 1615:2000 has the following relationships with other standards: It is inter standard links to EN 1615:1997, EN ISO 20695:2020. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase EN 1615:2000 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Katheter und Überleitungsgeräte zur enteralen Ernährung und ihre Konnektoren zur einmaligen Verwendung - Ausführung und PrüfungSondes et dispositifs de nutrition entérale non réutilisables et leurs raccords - Conception et essaisEnteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing11.040.25Injekcijske brizge, igle in katetriSyr
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EN 1615:2000 표준은 단일 사용을 위한 장입 영양 카테터 및 장입 투여 세트와 그 연결 시스템의 설계 및 테스트에 관한 중요한 내용들을 담고 있습니다. 이 표준의 주요 범위는 사용자의 안전성과 효율성을 보장하기 위해 이러한 장비들의 설계 요건과 시험 방법을 규정하는 데 중점을 두고 있습니다. 산업계에서의 적용 가능성 측면에서, 이 표준은 단일 사용 장입 영양 카테터와 투여 세트의 안전성을 높이는 데 기여하여, 환자의 치료 환경을 개선합니다. 특히, 이 표준은 사용자의 요구를 충족시키기 위해 제품의 기능성과 신뢰성을 강화하는 데 중요한 역할을 합니다. 또한, 이 표준은 장입 영양 카테터의 설계 및 검사에서 요구되는 구체적인 기준을 제시하지 않기 때문에, 산업계의 혁신을 지원하는 여지를 남겨두고 있습니다. 이러한 유연성은 제조업체들이 최신 기술과 연구 결과를 반영하여 제품을 개발할 수 있는 기회를 제공합니다. 현재 방사선 검출 가능성에 대한 표준 테스트 방법이 일반적으로 정립되어 있지 않지만, EN 1615:2000은 이러한 미래의 개발에 대한 기초적인 틀을 제공하고 있어, 향후 더욱 안전하고 효율적인 의료기기 개발에 기여할 것입니다. 규격화된 테스트 방법이 확립되면, 장입 영양 카테터의 안전성과 품질이 더욱 향상될 것으로 기대됩니다. 종합적으로, EN 1615:2000 표준은 단일 사용 장입 영양 카테터와 관련 제품의 설계 및 시험에 있어 매우 중요한 기준을设어주며, 향후 의료 분야에서의 지속적인 발전을 위한 기반이 될 것입니다.
EN 1615:2000は、使い捨ての腸管栄養カテーテルと腸管投与セット、そしてそれらの接続システムの設計および試験に関する要件を定めたヨーロッパ規格です。この標準は、製品の安全性と効果を確保するための重要なガイドラインを提供しており、特に医療現場での腸管栄養の質の向上に寄与します。 この文書の強みは、腸管栄養カテーテルと腸管投与セットの設計について具体的かつ詳細な要件を示していることです。これにより、製品が使用される環境下での利便性や安全性が保証され、医療従事者が患者に提供するケアの質を向上させることが可能です。また、この基準は、製品の製造者にとっても明確な設計指針となり、製品の一貫した品質を確保するための基盤を提供します。 さらに、EN 1615:2000は、使い捨て製品に特化しているため、感染リスクを軽減する重要な役割を果たしています。使い捨てカテーテルおよび投与セットの標準化により、患者の健康と安全が守られるだけでなく、医療施設の運用効率も向上します。 ただし、この標準は放射線検出可能な腸管栄養カテーテルに関する要件を含んでいないため、特定の条件下では放射線検出機能が求められる場合があることに注意が必要です。現在、放射線検出性に関する受け入れられた標準試験方法は存在しないため、この分野での研究と開発が進められています。これにより、今後の追加規格の策定や、既存の基準の改定が期待されます。 以上より、EN 1615:2000は、腸管栄養に関わる製品の設計と試験を包括的にカバーし、その強固な基盤が医療分野での信頼性向上に寄与することを示しています。本標準は、今後の整合性のある医療製品の開発において非常に重要な役割を果たすでしょう。
The EN 1615:2000 standard provides a comprehensive framework for the design and testing of single-use enteral feeding catheters and enteral giving sets, along with their connection systems. Its scope is notably specific, focusing on ensuring safety and efficacy in enteral feeding systems, which are critical for patients requiring nutritional support via the gastrointestinal tract. One of the strengths of this standard is its emphasis on rigorous design requirements, which help manufacturers ensure that the enteral feeding catheters are user-friendly and functionally effective. The detailed specifications included in the standard facilitate the development of products that minimize risk of mishaps during use, thus enhancing patient safety. Additionally, the focus on testing protocols allows for consistent quality assurance across different manufacturers, leading to improved trust in enteral feeding solutions. The relevance of EN 1615:2000 is particularly pronounced in clinical settings where enteral feeding is indispensable for patient care. By establishing clear guidelines for single-use enteral feeding catheters and their connectors, this standard plays a vital role in harmonizing practices across different healthcare facilities, ultimately reinforcing patient safety across the board. Moreover, the note regarding radiodetectable enteral feeding catheters illustrates the standard's consideration of evolving technologies in patient care, while also acknowledging current gaps in testing methodologies. This proactive approach highlights the standard's commitment to ongoing improvements in medical device safety and efficacy. In summary, EN 1615:2000 stands out as a pivotal standard, providing essential requirements that enhance the design and testing of enteral feeding catheters and giving sets, ensuring they meet high safety and quality benchmarks that are crucial in medical environments.
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