General Information

Abstract

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.

Status
Withdrawn
Publication Date
18-Feb-1997
Withdrawal Date
16-Sep-2026
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
08-Apr-2020
Completion Date
23-Sep-2026
Directive
Not Harmonized93/42/EEC - Medical devices
OJ Ref: C, C 144 OJ Date: 09-May-1998

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Relations

Effective Date
15-Apr-2020
Effective Date
28-Jan-2026
Effective Date
28-Jan-2026
Effective Date
28-Jan-2026

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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, EN 1615:2000, EN 13718-2:2015+A1:2020, EN 13718-2:2015. 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.

EN 1618:1997 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.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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