Sterile, Single-use Intravascular Catheters — Part 1: General Requirements
1 Scope
This part of YY 0285 specifies general requirements for intravascular catheters, supplied in the sterile condition and intended for single use, for any application.
This part of YY 0285 does not apply to intravascular catheter accessories.
Note: The requirements of accessories as specified in YY 0450.
2 Normative References
The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of YY 0285. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies.
GB/T 1962 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment (all parts) (idt ISO 594)
GB 15810 Sterile syringes for single use (GB 15810-1995, eqv ISO 7886-1:1993)
3 Terms and Definitions
For the purposes of this part of YY 0285, the following terms and definitions apply.
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)℃ 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
Sterile, Single-use Intravascular Catheters — Part 1: General Requirements
1 Scope
This part of YY 0285 specifies general requirements for intravascular catheters, supplied in the sterile condition and intended for single use, for any application.
This part of YY 0285 does not apply to intravascular catheter accessories.
Note: The requirements of accessories as specified in YY 0450.
2 Normative References
The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of YY 0285. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies.
GB/T 1962 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment (all parts) (idt ISO 594)
GB 15810 Sterile syringes for single use (GB 15810-1995, eqv ISO 7886-1:1993)
3 Terms and Definitions
For the purposes of this part of YY 0285, the following terms and definitions apply.
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)℃ 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
4 Requirements
