This part of YY 0285 specifies the requirements for over-the-needle peripheral intravascular catheters, intended for accessing the peripheral vascular system, supplied in the sterile condition and intended for single use.
Note: attention should be drawn to YY 0450.1, which specifies requirements for accessory devices for use with intravascular catheters; and to YY 0450.2, which specifies catheter plug for over-the needle peripheral intravascular catheters.
2 Normative References
The following normative documents contain provisions which, through reference of YY 0285, constitute provisions of this part. For dated references, subsequent amendments to (excluding amending errors), or revisions of, any of these publications do not apply. However, all parties coming to an agreement according to this part are encouraged to study whether the latest edition of these documents is applicable. For undated references, the latest edition of this part applies.
GB/T 1962.1 Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 1: General Requirement (GB/T, 1962.1-2001, idt ISO 594-1: 1986)
GB 18457 Stainless Steel Needle Tubing for Manufacture of Medical Devices (GB 18457-2001, eqv ISO 9626: 1991)
YY 0285.1 Sterile, Single-use Intravascular Catheters - Part 1: General Requirements (YY 0285.1-2004, ISO 10555-1: 1995, IDT)
3 Definitions
For the purpose of this part of YY 0285, the definitions given in YY 0285.1 and the following definitions apply.
Foreword I 1 Scope 2 Normative References 3 Definitions 4 Requirements Appendix A (Normative) Determination of Strength of Union of Needle Hub and Needle Tube Appendix B (Informative) Determination of Flow Rate through Catheter Appendix C (Normative) Colors for Opaque Catheter Hubs Appendix D (Informative) Needle Point Geometries Appendix E (Normative) Determination of Fluid Leakage for Vent Fitting References
1 Scope
This part of YY 0285 specifies the requirements for over-the-needle peripheral intravascular catheters, intended for accessing the peripheral vascular system, supplied in the sterile condition and intended for single use.
Note: attention should be drawn to YY 0450.1, which specifies requirements for accessory devices for use with intravascular catheters; and to YY 0450.2, which specifies catheter plug for over-the needle peripheral intravascular catheters.
2 Normative References
The following normative documents contain provisions which, through reference of YY 0285, constitute provisions of this part. For dated references, subsequent amendments to (excluding amending errors), or revisions of, any of these publications do not apply. However, all parties coming to an agreement according to this part are encouraged to study whether the latest edition of these documents is applicable. For undated references, the latest edition of this part applies.
GB/T 1962.1 Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 1: General Requirement (GB/T, 1962.1-2001, idt ISO 594-1: 1986)
GB 18457 Stainless Steel Needle Tubing for Manufacture of Medical Devices (GB 18457-2001, eqv ISO 9626: 1991)
YY 0285.1 Sterile, Single-use Intravascular Catheters - Part 1: General Requirements (YY 0285.1-2004, ISO 10555-1: 1995, IDT)
3 Definitions
For the purpose of this part of YY 0285, the definitions given in YY 0285.1 and the following definitions apply.
Contents of YY 0285.5-2004
Foreword I
1 Scope
2 Normative References
3 Definitions
4 Requirements
Appendix A (Normative) Determination of Strength of Union of Needle Hub and Needle Tube
Appendix B (Informative) Determination of Flow Rate through Catheter
Appendix C (Normative) Colors for Opaque Catheter Hubs
Appendix D (Informative) Needle Point Geometries
Appendix E (Normative) Determination of Fluid Leakage for Vent Fitting
References
