YY / ISO 11070:1998

Transcription

1 Translated English of Chinese Standard: YY PHARMACEUTICAL INDUSTRY STANDARD YY OF THE PEOPLE S REPUBLIC OF CHINA ICS C 48 YY / ISO 11070:1998 Accessory devices for sterile single-use intravascular catheters - Part 1: Introducers (ISO 11070:1998 Sterile single-use intravascular catheter introducers, IDT) 一次性使用无菌血管内导管辅件第 1 部分 : 导引器械 Issued on: February 9, 2003 Implemented on: September 1, 2003 Issued by: China Food and Drug Administration Page 1 of 28

2 Table of Contents Foreword Scope Normative references Terms and definitions General requirements Additional requirements for introducer needles Additional requirements for introducer catheters Additional requirements for sheath introducers Additional requirements for guide wires Additional requirements for dilators Additional requirements for kits containing combinations of devices specified in this Part Annex A (Informative) Guidance on materials and design Annex B (Normative) Test for corrosion resistance Annex C (Normative) Determination f force at break of introducer catheters, sheath introducers and dilators Annex D (Normative) Test for liquid leakage from sheath 1ntroducers 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 flexing24 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 Page 2 of 28

3 Foreword This Part of YY 0450 identically uses ISO 11070:1998 Sterile single-use intravascular catheter introducers. The total title of YY 0450 is Accessory devices for sterile single-use intravascular catheters. It consists of the following parts: - Part 1: Introducers; - Part 2: Obturators for over-needle peripheral catheters. Annex B, Annex C, Annex D, Annex E, Annex F, Annex G and Annex H of this Part are normative. Annex A and Annex J are informative. This Part was proposed by State Drug Administration. This Part shall be under the jurisdiction of State Drug Administration Jinan Medical Device Quality Supervision and Inspection Center. The drafting organization of this Part: State Drug Administration Jinan Medical Device Quality Supervision and Inspection Center. Main drafters of this Part: Wang Yanwei, Wu Ping, Xin Rendong, Zhang Qiang. Page 3 of 28

4 Accessory devices for sterile single-use intravascular catheters - Part 1: Introducers 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 NOTE Guidance on materials and design of accessory devices is given in Annex A. 2 Normative references The provisions in following documents become the provisions of this Part through reference in this Standard. For dated references, the subsequent amendments (excluding corrigendum) or revisions do not apply to this Part, however, parties who reach an agreement based on this Part are encouraged to study if the latest versions of these documents are applicable. For undated references, the latest edition of the referenced document applies. GB/T , Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirement (GB/T , idt ISO 594-1:1986) GB/T , Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings (GB/T , idt ISO 594-2:1998) GB 15810, Sterile hypodermic syringes for single use (GB/T , eqv ISO :1993, Sterile hypodermic syringes for sing-use - Part 1: Syringes for manual use) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. NOTE - Schematic examples of the devices covered by this Part, with examples of terminology, are given for information in figures 1, 2 and 3. Page 4 of 28

5 Annex J (Informative) Bibliography [1] GB , Sterile hypodermic needles for single use (eqv ISO 7865:1993) [2] GB , Stainless steel needle tubing for manufacture of medical devices (eqv ISO 9626:1991) [3] YY , Sterile, single-use intravascular catheters - Part 1: General requirements (idt ISO :1995) [4] YY , Sterile single-use intravascular catheters - Part 2: Angiographic catheters (idt ISO :1996) [5] YY , Sterile single-use intravascular catheters - Part 3: Central venous catheters (idt ISO :1996) [6] YY , Sterile single-use intravascular catheters - Part 4: Balloon dilatation catheters (idt ISO :1996) [7] YY , Sterile single-use intravascular catheters - Part 5: Over-needle peripheral catheters (idt ISO :1996) [8] GB/T , Biological evaluation of medical devices--part 1: Evaluation and testing (idt ISO :1997) [9] GB , Sterilization of health care products - Requirements for validation and routine control - Industrial moist heat sterilization (idt ISO 11134:1994) [10] GB , Sterilization of health care products - Requirements for validation and routine control - Industrial moist heat sterilization (idt ISO 11135:1994) [11] GB , Sterilization of health care products - Requirement for validation and routine control - Radiation sterilization (idt ISO 11137:1995) END Page 28 of 28