CEN/TC 205/WG 6 - Catheters and enteral feeding tubes

This Standard specifies test methods for kinking properties for single lumen catheters and medical tubing as they relate to the device ready for clinical use. The purpose of the standard is to ensure uniformity in the evaluation of tubing kink properties.

This European Standard specifies requirements for single-use rectal catheters intended to be inserted into the rectum of a patient, for emptying, rinsing or filling purposes.

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 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.

To correct error in composition of test liquid.

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 urethral catheters, with and without balloons.

Migrated from Progress Sheet (TC Comment) (2000-07-10): This WI will probably go to a PV procedure. ++ Target dates agreed under Resolution BTS3 H C4/1992.

Migrated from Progress Sheet (TC Comment) (2000-07-10): This WI will probably go to a PV procedure. ++ Target dates agreed under Resolution BTS3 H C4/1992.

Specifies general requirements for intravascular catheters, supplied in the sterile condition and intended for single use, for any application. Does not apply to intravascular catheter accessories, which will be covered by a separate standard.

To amend EN ISO 10555-5 so as to include a method of test for blood leakage from vent fittings.

Migrated from Progress Sheet (TC Comment) (2000-07-10): This WI will probably go to a PV procedure. ++ Target dates agreed under Resolution BTS3 H C4/1992.

Migrated from Progress Sheet (TC Comment) (2000-07-10): This WI will probably go to a PV procedure. ++ Target dates agreed under Resolution BTS3 H C4/1992. ++ BTS3 C 003/1996 N 532(TD: 1996-07-17 !!!!  , today=1996-05-20) ++ Res. TC 214(Budapest 8): TC 215 recommends a package for ++ EN ISO 10555-1 & 10555-5; DAV= DOW+6months, DOW for both= January 1998!!!

Migrated from Progress Sheet (TC Comment) (2000-07-10): This WI will probably go to a PV procedure. ++ Target dates agreed under Resolution BTS3 H C4/1992.

To amend EN ISO 10555-1 so as to include requirements for hydratable catheters.

This part of ISO 10555 specifies general requirements for intravascular catheters, supplied in the sterile condition and intended for single use, for any application.  It does not apply to intravascular catheter accessories, which will be covered by a separate standard.

This European standard specifies requirements for sterile single use enteral feeding catheters, enteral giving sets and their connection systems. This European standard does not apply to enteral feeding catheters in which the external diameter of the tube is greater than 7 mm or to gastro-intestinal catheters primarily intended for the administration of medication.