YY 0450.1-2003_English: PDF (YY0450.1-2003)
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Accessory devices for sterile single-use intravascular catheters. Part 1: Introducers
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YY 0450.1-2003
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| YY 0450.1-2020 | English | 425 |
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Accessory devices for sterile single-use intravascular catheters--Part 1: Introducers
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YY 0450.1-2020
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Newer version: YY 0450.1-2020 Standards related to: YY 0450.1-2020
| Standard ID | YY 0450.1-2003 (YY0450.1-2003) | | Description (Translated English) | Accessory devices for sterile single-use intravascular catheters. Part 1: Introducers | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C48 | | Classification of International Standard | 11.120.30 | | Word Count Estimation | 19,198 | | Date of Issue | 2003-02-09 | | Date of Implementation | 2003-09-01 | | Adopted Standard | ISO 11070-1998, IDT | | Drafting Organization | State Drug Administration Jinan Medical Device Quality Supervision and Inspection Center | | Administrative Organization | State Drug Administration Jinan Medical Device Quality Supervision and Inspection Center | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the requirements and compliance standards YY 0285 intravascular catheters used together to supply disposable sterile needle, guide tube, catheter sheath, guidewire and dilator requirements. | YY 0450.1-2003
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.120.30
C 48
YY 0450.1-2003 / ISO 11070.1998
Accessory devices for sterile single-use
intravascular catheters - Part 1. Introducers
(ISO 11070.1998 Sterile single-use
intravascular catheter introducers, IDT)
ISSUED ON. FEBRUARY 9, 2003
IMPLEMENTED ON. SEPTEMBER 1, 2003
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 General requirements ... 7
5 Additional requirements for introducer needles ... 9
6 Additional requirements for introducer catheters ... 10
7 Additional requirements for sheath introducers ... 11
8 Additional requirements for guide wires ... 12
9 Additional requirements for dilators ... 13
10 Additional requirements for kits containing combinations of devices
specified in this Part ... 14
Annex A (Informative) Guidance on materials and design ... 15
Annex B (Normative) Test for corrosion resistance ... 16
Annex C (Normative) Determination f force at break of introducer catheters,
sheath introducers and dilators ... 17
Annex D (Normative) Test for liquid leakage from sheath 1ntroducers under
pressure ... 19
Annex E (Normative) Test for liquid leakage through haemostasis valves of
sheath introducers ... 21
Annex F (Normative) Test for fracture of guide wires ... 22
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 ... 26
Annex J (Informative) Bibliography ... 28
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.
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 0285.
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 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 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.
Annex J
(Informative)
Bibliography
[1] GB 15811-2001, Sterile hypodermic needles for single use (eqv ISO
7865.1993)
[2] GB 18457-2001, Stainless steel needle tubing for manufacture of
medical devices (eqv ISO 9626.1991)
[3] YY 0285.1-1999, Sterile, single-use intravascular catheters - Part 1.
General requirements (idt ISO 10555-1.1995)
[4] YY 0285.2-1999, Sterile single-use intravascular catheters - Part 2.
Angiographic catheters (idt ISO 10555-2.1996)
[5] YY 0285.3-1999, Sterile single-use intravascular catheters - Part 3.
Central venous catheters (idt ISO 10555-3.1996)
[6] YY 0285.4-1999, Sterile single-use intravascular catheters - Part 4.
Balloon dilatation catheters (idt ISO 10555-4.1996)
[7] YY 0285.5-1999, Sterile single-use intravascular catheters - Part 5.
Over-needle peripheral catheters (idt ISO 10555-5.1996)
[8] GB/T 16886.1-2001, Biological evaluation of medical devices--Part 1.
Evaluation and testing (idt ISO 10993-1.1997)
[9] GB 18278-2000, Sterilization of health care products - Requirements for
validation and routine control - Industrial moist heat sterilization (idt ISO
11134.1994)
[10] GB 18279-2000, Sterilization of health care products - Requirements
for validation and routine control - Industrial moist heat sterilization (idt
ISO 11135.1994)
[11] GB 18280-2000, Sterilization of health care products - Requirement for
validation and routine control - Radiation sterilization (idt ISO
11137.1995)
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