YY 0285.1-2004Sterile, single-use intravascular catheters - Part 1: General requirements (English PDF)

3.1 Intravascular catheter

Tubular device, single or multilumen, designed to be partially or totally inserted or implanted into the cardiovascular system for diagnostic and/or therapeutic purposes.

3.2 Distal end

End of the catheter inserted furthest into the patient.

3.3 Proximal end; access end

End of the catheter to which connection can be made.

3.4 Hub

Connector(s) at the proximal end of the catheter which may either be integral with the catheter or be capable of being securely fitted to the proximal end of the catheter.

3.5 Effective length, l

Length of the catheter that can be inserted into the body (See figure 1).

3.6 Outside diameter

Maximum diameter of that part of the catheter that can be inserted into the vessel.

3.7 Junction

That portion of the catheter that joins one tube to multiple tubes.

3.8 Hydratable intravascular catheter

Intravascular catheter consisting of a material that manifests clinically significant hydration when subjected to an aqueous medium.

3.9 Post-hydration

State of a hydratable intravascular catheter after immersion in water at (37 ± 2)°C for 2 h.

3.10 Clinically significant hydration

Hydrated state in which either the post-hydration effective length is greater than the pre-hydration effective length by more than 4 mm or 1 % of the effective length, whichever is the lesser, or the post-hydration outside diameter is greater than the pre-hydration outside diameter by 10 % or more.

Note: l = effective length;

1 - catheter hub;

2 - catheter strain reinforcement;

3 - length mark;

4 - junction.

Figure 1 Examples of Effective Length of Catheters