This part of YY 0450 specifies requirements for introducer needles, introducer catheters, sheath introducers, guide wires and dilators supplied in the sterile condition, and intended for single use in conjunction with intravascular catheters specified in YY 0285.
Note: Guidance on materials and design of accessory devices is given in annex A.
2 Normative References
The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of YY 0450. For dated references, subsequent amendments (excluding corrections), or revisions, of any of these publications do not apply to this standard. 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 1962.1 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/T 1962.2 Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain other Medical Equipment — Part 2: Lock Fittings (GB/T 1962.2-2001, idt ISO 594-2:1998)
GB 15810 Sterile Hypodermic Syringes for Single Use (GB/T 15810-2001, eqv ISO 7886-1:1993, Sterile Hypodermic Syringes for Single-use — Part 1: Syringes for Manual Use)
3 Terms and Definitions
For the purposes of this part, the following terms and definitions apply.
Note: Schematic examples of the devices covered by this International Standard, with examples of terminology, are given for information in figures 1, 2 and 3.
Foreword II 1 Scope 2 Normative References 3 Terms and Definitions 4 General Requirements 5 Additional Requirements for Introducer Needles 6 Additional Requirements for Introducer Catheters 7 Additional Requirements for Sheath Introducers 8 Additional Requirements for Guide Wires 9 Additional Requirements for Dilators 10 Additional Requirements for Kits Containing Combinations of Devices Specified in This Standard Annex A (Informative) Guidance on Materials and Design Annex B (Normative) Test for Corrosion Resistance Annex C (Normative) Determination of Force at Break of Introducer Catheters, Sheath Introducers and Dilators Annex D (Normative) Test for Liquid Leakage from Sheath Introducers under Pressure Annex E (Normative) Test for Liquid Leakage Through Haemostasis Valves of Sheath Introducers Annex F (Normative) Test for Fracture of Guide Wires Annex G (Normative) Test for Resistance of Guide Wires to Damage by Flexing Annex H (Normative) Test for Strength of Union of Core Wire and Coil of Guide Wire and Union of Coil and Safety Wire Annex J (Informative) Bibliography
1 Scope
This part of YY 0450 specifies requirements for introducer needles, introducer catheters, sheath introducers, guide wires and dilators supplied in the sterile condition, and intended for single use in conjunction with intravascular catheters specified in YY 0285.
Note: Guidance on materials and design of accessory devices is given in annex A.
2 Normative References
The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of YY 0450. For dated references, subsequent amendments (excluding corrections), or revisions, of any of these publications do not apply to this standard. 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 1962.1 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/T 1962.2 Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain other Medical Equipment — Part 2: Lock Fittings (GB/T 1962.2-2001, idt ISO 594-2:1998)
GB 15810 Sterile Hypodermic Syringes for Single Use (GB/T 15810-2001, eqv ISO 7886-1:1993, Sterile Hypodermic Syringes for Single-use — Part 1: Syringes for Manual Use)
3 Terms and Definitions
For the purposes of this part, the following terms and definitions apply.
Note: Schematic examples of the devices covered by this International Standard, with examples of terminology, are given for information in figures 1, 2 and 3.
Contents of YY 0450.1-2003
Foreword II
1 Scope
2 Normative References
3 Terms and Definitions
4 General Requirements
5 Additional Requirements for Introducer Needles
6 Additional Requirements for Introducer Catheters
7 Additional Requirements for Sheath Introducers
8 Additional Requirements for Guide Wires
9 Additional Requirements for Dilators
10 Additional Requirements for Kits Containing Combinations of Devices Specified in This Standard
Annex A (Informative) Guidance on Materials and Design
Annex B (Normative) Test for Corrosion Resistance
Annex C (Normative) Determination of Force at Break of Introducer Catheters, Sheath Introducers and Dilators
Annex D (Normative) Test for Liquid Leakage from Sheath Introducers under Pressure
Annex E (Normative) Test for Liquid Leakage Through Haemostasis Valves of Sheath Introducers
Annex F (Normative) Test for Fracture of Guide Wires
Annex G (Normative) Test for Resistance of Guide Wires to Damage by Flexing
Annex H (Normative) Test for Strength of Union of Core Wire and Coil of Guide Wire and Union of Coil and Safety Wire
Annex J (Informative) Bibliography
