EN 1618:1997
(Main)Catheters other than intravascular catheters - Test methods for common properties
Catheters other than intravascular catheters - Test methods for common properties
This European Standard specifies test methods for common properties for catheters as they relate to the device ready for clinical use. The purpose of the standard is to ensure uniformity in the evaluation of catheter properties. This European Standard is not applicable to intravascular catheters.
Nicht-intravasale Katheter - Prüfverfahren für allgemeine Eigenschaften
Diese Norm legt Prüfmethoden für allgemeine Eigenschaften bei Kathetern, insofern diese für klinische Verwendung relevant sind, fest. Der Zweck der Normist die Sicherung von einheitlicher Beurteilung der Kathetereigenschaften. Intravaskuläre Katheter werden von dieser Norm nicht erfaßt.
Cathéters autres que les cathéters intravasculaires - Méthodes d'essai des propriétés communes
La présente norme prescrit des méthodes d'essai concernant les propriétés communes aux cathéters sous leur forme prête à l'emploi, pour l'utilisation clinique. L'objet de la présente norme est de garantir l'évaluation uniforme despropriétés des cathéters. La présente norme ne s'applique pas aux cathéters intravasculaires.
Katetri, razen žilnih (intravaskularnih) katetrov - Preskusne metode za ugotavljanje splošnih lastnosti
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Frequently Asked Questions
EN 1618:1997 is a standard published by the European Committee for Standardization (CEN). Its full title is "Catheters other than intravascular catheters - Test methods for common properties". This standard covers: This European Standard specifies test methods for common properties for catheters as they relate to the device ready for clinical use. The purpose of the standard is to ensure uniformity in the evaluation of catheter properties. This European Standard is not applicable to intravascular catheters.
This European Standard specifies test methods for common properties for catheters as they relate to the device ready for clinical use. The purpose of the standard is to ensure uniformity in the evaluation of catheter properties. This European Standard is not applicable to intravascular catheters.
EN 1618:1997 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 1618:1997 has the following relationships with other standards: It is inter standard links to EN ISO 20695:2020. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 1618:1997 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.Katetri, razen žilnih (intravaskularnih) katetrov - Preskusne metode za ugotavljanje splošnih lastnostiNicht-intravasale Katheter - Prüfverfahren für allgemeine EigenschaftenCathéters autres que les cathéters intravasculaires - Méthodes d'essai des propriétés communesCatheters other than intravascular catheters - Test methods for common properties11.040.20Transfuzijska, infuzijska in in
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표준 EN 1618:1997은 비내혈관 카테터에 대한 공통 물성 테스트 방법을 규정하고 있으며, 임상 사용을 위한 기기 준비와 관련하여 카테터의 특성을 평가하는 데 있어 일관성을 확보하는 것을 목표로 합니다. 이 표준의 주요 범위는 카테터가 임상에서 사용되기 전의 준비 상태를 기준으로 하여, 다양한 물리적 및 화학적 특성을 테스트하는 방법을 명시합니다. 이 표준의 강점 중 하나는 카테터의 다양한 물성을 체계적으로 평가할 수 있는 구체적인 테스트 방법을 제공한다는 점입니다. 이는 의료 기기의 안전성과 효율성을 높이는 데 기여하며, 피험자와 의료진의 안전을 보장하는 데 필수적입니다. 또한, 이 표준은 유럽 내 카테터 제조업체가 공통된 기준을 준수하도록 함으로써, 제품의 품질 향상과 생명선 연결의 신뢰성을 높이는 데 중요한 역할을 합니다. EN 1618:1997의 관련성은 카테터와 같은 의료 기기의 발전과 안전성이 점차 강조되는 현대 의료 환경에서 더욱 뚜렷해집니다. 카테터는 다양한 의료 절차에서 널리 사용되기 때문에, 이에 대한 표준화된 테스트 방법은 임상적 성공 여부에 직접적인 영향을 미치는 요소이며, 따라서 이 표준은 의료 기기 분야에서 매우 중요합니다. 이러한 이유로 EN 1618:1997은 카테터 관련 국제적 기준을 설정하는 데 있어 필수적인 기반이 됩니다.
The EN 1618:1997 standard provides a comprehensive framework focused on the test methods for common properties of catheters that are not intravascular in nature. Its scope is critically defined, targeting the evaluation of catheter properties specifically when the device is prepared for clinical use. This ensures that manufacturers and healthcare providers have a consistent, reliable method for assessing the quality and safety of various catheter types outside of the intravascular category. One of the key strengths of EN 1618:1997 lies in its emphasis on uniformity in testing methodologies. By establishing standardized test methods, the standard promotes consistency across different manufacturers and types of catheters, which is essential for ensuring the reliability of these medical devices in clinical settings. This uniform approach minimizes variability in testing results, potentially leading to improved patient safety and enhanced outcomes. Additionally, the relevance of this standard cannot be overstated. In an era where medical devices, particularly catheters, are subject to rigorous safety and efficacy evaluations, having a dedicated standard that addresses the common properties of non-intravascular catheters is crucial. It fills a significant gap in regulatory frameworks by providing essential guidelines that facilitate compliance with health regulations and reassure healthcare professionals of the quality of the devices they use. Ultimately, EN 1618:1997 serves as a vital resource for manufacturers and regulatory bodies alike, ensuring that catheters intended for clinical use can be reliably tested and evaluated. The focus on common properties contributes to a higher level of assurance regarding the performance and safety of these crucial medical devices, adding to the comprehensive nature of its applicability in the healthcare industry.
SIST EN 1618:2000は、臨床使用のために準備されたカテーテルの共通特性に関する試験方法を規定している、非常に重要な欧州規格です。この標準は、カテーテルの特性評価における均一性を確保することを目的としており、カテーテルの品質向上に寄与するものです。 この標準の範囲は、特に血管内カテーテルを除くカテーテルに適用され、さまざまなタイプのカテーテルに対して一貫した試験基準を提供します。これにより、医療機器メーカーは自社の製品の性能を評価しやすくなり、医療現場においても信頼性の高い製品が供給されることにつながります。 SIST EN 1618:2000の強みは、その明確な試験方法によって規定される評価基準です。これにより、異なる製品間での比較が容易になり、医療従事者はカテーテルの選定時により正確な情報に基づいた判断を行うことができるようになります。また、標準が提示する試験方法は、カテーテルが臨床使用において必要とされる特性を確実に測定するための信頼性の高い指針となります。 この標準は、医療機器の安全性と効果を保証するためにも極めて重要であり、医療現場におけるカテーテルの使用に広く関連しています。カテーテルの評価と選定における均一な基準を提供することにより、患者の安全を確保し、高品質な医療サービスの提供に貢献しています。 全体として、SIST EN 1618:2000はカテーテルの共通特性に関する重要な試験方法を示し、その適用範囲と明確な評価基準は、医療業界におけるカテーテルの質向上に不可欠な要素です。
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