EN 1617:1997
(Main)Sterile drainage catheters and accessory devices for single use
Sterile drainage catheters and accessory devices for single use
This standard specifies requirements for sterile,single use drainage catheters, wound drainage systems and components thereof designed for drainage of fluids tothe exterior by means of gravity or negative pressure. This E. S. does not applyto: -catheters of less than 2 mm outside diameter;-suction catheters for use in the respiratory tract (see prEN 1733);-tracheal catheters (tracheal tubes) (see prEN 1782). NOTE: Urinary tract catheters are covered in prEN 1616.
Sterile Drainagekatheter und Zubehör zur einmaligen Verwendung
Diese Europäische Norm legt Anforderungen an sterile Drainagekatheter und derenBestandteile zur einmaligen Verwendung fest, die zur Ableitung von Flüssig- keiten aus dem Körper mittels Schwerkraft oder Unterdruck bestimmt sind. Diese Europäische Norm gilt nicht für: -Katheter mit einem Aussendurchmesser uter 2 mm;- Absaugkatheter zur Verwendung im Atmungstrakt (siehe prEN 1733°._ Trache-altkatheter (Trachealtuben) (siehe pr EN 1782). ANMERKUNG: Katheter für die Harnwege werden durch prEN 1616 erfasst.
Sondes et dispositifs accessoires stériles de drainage, non réutilisables
La présente norme fixe des prescriptions pour les sondes de drainage, les sys- tèmes de drainage des plaies et leurs composants stériles non réutilisables, conçus pour le drainage des liquides vers l'extérieur, par gravité ou par dé- pression. La présente norme ne s'applique pas aux: sondes de diamètre extérieur < 2mm;-sondes d'aspiration pour usage dans les voies aériennes(voir prEN1733);- tubes trachéaux (voir prEN 1782). NOTE: Les sondes urinaires sont traitées par le prEN 1616.
Sterilni drenažni katetri in dodatki za enkratno uporabo
General Information
- Status
- Withdrawn
- Publication Date
- 18-Feb-1997
- Withdrawal Date
- 20-Jan-2026
- 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
- 04-Jul-2018
- Completion Date
- 21-Jan-2026
Relations
- Effective Date
- 15-Jul-2018
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Frequently Asked Questions
EN 1617:1997 is a standard published by the European Committee for Standardization (CEN). Its full title is "Sterile drainage catheters and accessory devices for single use". This standard covers: This standard specifies requirements for sterile,single use drainage catheters, wound drainage systems and components thereof designed for drainage of fluids tothe exterior by means of gravity or negative pressure. This E. S. does not applyto: -catheters of less than 2 mm outside diameter;-suction catheters for use in the respiratory tract (see prEN 1733);-tracheal catheters (tracheal tubes) (see prEN 1782). NOTE: Urinary tract catheters are covered in prEN 1616.
This standard specifies requirements for sterile,single use drainage catheters, wound drainage systems and components thereof designed for drainage of fluids tothe exterior by means of gravity or negative pressure. This E. S. does not applyto: -catheters of less than 2 mm outside diameter;-suction catheters for use in the respiratory tract (see prEN 1733);-tracheal catheters (tracheal tubes) (see prEN 1782). NOTE: Urinary tract catheters are covered in prEN 1616.
EN 1617:1997 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 1617:1997 has the following relationships with other standards: It is inter standard links to EN ISO 20697:2018. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 1617:1997 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.Sterilni drenažni katetri in dodatki za enkratno uporaboSterile Drainagekatheter und Zubehör zur einmaligen VerwendungSondes et dispositifs accessoires stériles de drainage, non réutilisablesSterile drainage catheters and accessory devices for single use11.040.25Injekcijske brizge, igl
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