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YY 0450.1-2020 English PDF (YY0450.1-2020)

YY 0450.1-2020 English PDF (YY0450.1-2020)

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YY 0450.1-2020: Accessory devices for sterile single-use intravascular catheters--Part 1: Introducers

YY 0450.1-2020
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.25
C 31
Replacing YY 0450.1-2003
Accessory Devices for Sterile Single-use Intravascular
Catheters - Part 1: Introducers
(ISO 11070:2014, Sterile Single-use Intravascular Introducers, Dilators and Guidewires, MOD)
ISSUED ON: FEBRUARY 25, 2020
IMPLEMENTED ON: AUGUST 1, 2021
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 5
1 Scope ... 8
2 Normative References ... 8
3 Terms and Definitions ... 9
4 General Requirements ... 13
4.1 Sterilization ... 13
4.2 Biocompatibility ... 13
4.3 Surface ... 13
4.4 Corrosion Resistance ... 14
4.5 Radio-detectability ... 14
4.6 Information to be Supplied by the Manufacturer ... 14
5 Additional Requirements for Introducer Needles ... 15
5.1 General Rules ... 15
5.2 Size Designation ... 15
5.3 Needle Point ... 15
5.4 Hub ... 15
5.4.1 Conical fitting ... 15
5.4.2 Strength of union of needle tube and needle hub ... 15
5.5 Information to be Supplied by the Manufacturer ... 15
6 Additional Requirements for Introducer Catheters ... 16
6.1 General Rules ... 16
6.2 Tip ... 16
6.3 Peak Tensile Force ... 16
6.4 Hub ... 16
6.5 Size Designation ... 17
6.6 Information to be Supplied by the Manufacturer ... 17
7 Additional Requirements for Sheath Introducers ... 17
7.1 General Rules ... 17
7.2 Size Designation ... 17
7.3 Free of Leakage from Sheath Introducer ... 17
7.4 Free of Leakage through Hemostasis Valve ... 18
7.5 Hub ... 18
7.6 Peak Tensile Force ... 18
7.7 Information to be Supplied by the Manufacturer ... 18
8 Additional Requirements for Guidewires ... 18
8.1 General Rules ... 18
8.2 Size Designation ... 18
8.3 Safety Wire ... 18
8.4 Fracture Test ... 18
8.5 Bending Test ... 19
8.6 Peak Tensile Force of Guidewire ... 19
8.7 Information to be Supplied by the Manufacturer ... 19
9 Additional Requirements for Dilators ... 20
9.1 General Rules ... 20
9.2 Size Designation ... 20
9.3 Hub ... 20
9.3.1 General rules ... 20
9.3.2 Conical fitting ... 20
9.3.3 Strength of union between hub and dilator ... 20
9.4 Information to be Supplied by the Manufacturer ... 20
10 Additional Requirements for Kits Containing Combinations of Devices
Specified in this Part ... 21
11 Determination of Strength of Union of Needle Hub and Needle ... 21
Appendix A (informative) Materials and Design ... 22
Appendix B (normative) Test Method for Corrosion Resistance ... 23
Appendix C (normative) Determination Method of Peak Tensile Force of
Introducer Catheters, Sheath Introducers and Dilators ... 24
Appendix D (normative) Test Method for Liquid Leakage from Sheath
Introducers under Pressure ... 26
Appendix E (normative) Test Method for Liquid Leakage from Hemostasis
Valves of Sheath Introducers ... 28
Appendix F (normative) Test Method for Fracture of Guidewires ... 29
Appendix G (normative) Test Method for Guidewire Resistance to Bending
Damage ... 31
Appendix H (normative) Determination Method for Peak Tensile Force of
Guidewire ... 33
Appendix I (normative) Determination of Strength of Union of Needle Hub and Needle ... 35
Bibliography ... 36
Foreword
Some content of 6.2 in this Part is recommended, and the remaining is
mandatory.
YY 0450 Accessory Devices for Sterile Single-use Intravascular Catheters is composed of the following parts:
---Part 1: Introducers;
---Part 2: Obturators for Over-needle Peripheral Catheters;
---Part 3: Inflation Devices for Balloon of Balloon Dilatation Catheters. This Part is Part 1 of YY 0450.
This Part was drafted in accordance with the rules provided in GB/T 1.1-2009. This Part serves as a replacement of YY 0450.1-2003 Accessory Devices for Sterile Single-use Intravascular Catheters - Part 1: Introducers.
In comparison with YY 0450.1-2003, other than editorial modifications, the main technical changes are as follows:
---Some requirements and test methods of guidewires are modified (see Chapter 8; Chapter 8 of Version 2003);
---The requirements for size designation are modified (see 5.2, 6.5, 7.2, 8.2 and 9.2; see 5.2, 6.5, 7.2, 8.2 and 9.2 of Version 2003);
---Appendix I “Determination Method of Strength of Union of Needle Hub and Needle” is added (see Appendix I);
This Part adopts the re-drafting law to modify the adoption of ISO 11070:2014 Sterile Single-use Intravascular Introducers, Dilators and Guidewires.
In comparison with ISO 11070:2014, there are structural differences. The differences and the causes for these differences are shown below:
---Chapter 11 “Determination of Strength of Union of Needle Hub and Needle” is added, which quotes Appendix I; meanwhile, 5.4.2 is modified, which quotes Chapter 11, so as to comply with the requirements of GB/T 1.1 for the sequence of the appendix of volume in this Part. In comparison with ISO 11070:2014, there is no technical difference.
In comparison with ISO 11070:2014, there are technical differences. The differences and the causes for these differences are shown below:
---In terms of Normative References, this Part makes adjustments with technical differences, so as to adapt to the technical conditions of China. The
adjustments are intensively reflected in Chapter 2 “Normative References”. See the specific adjustments below:
 GB/T 1962.1, which equivalently adopts International Standard, is used to replace ISO 594-1;
 GB/T 1962.2, which equivalently adopts International Standard, is used to replace ISO 594-2;
 GB/T 7408, which equivalently adopts International Standard, is used to replace ISO 8601;
 GB 15810, which equivalently adopts International Standard, is used to replace ISO 7886-1;
 GB/T 16886.1, which equivalently adopts International Standard, is used to replace ISO 10993-1;
 YY/T 0466.1, which equivalently adopts International Standard, is used to replace ISO 15223-1;
 Use YY/T 0586-2016 to replace ASTM F640-12 and DIN 13273-7.
---In terms of footnote, this Part makes adjustments with technical differences. See the specific adjustments below:
Footnote 1) and Footnote 2) are modified, so as to adapt to the current international and national technical conditions.
Please be noted that certain content of this document might involve patents. The institution issuing this document does not undertake the responsibility of identifying these patents.
This Part was proposed by China Food and Drug Administration.
This Part shall be under the jurisdiction of National Technical Committee 106 on Medical Syringes of Standardization Administration of China.
The drafting organizations of this Part: Shandong Quality Inspection Center for Medical Devices; Lepu Medical Technology (Beijing) Co., Ltd.; Medtronic (Shanghai) Management Co., Ltd.; Shanghai MicroPort Medical Devices (Group) Co., Ltd.; Shandong Weigao Group Medical Polymer Company Limited.
The main drafters of this Part: Wan Min, Xu Jiajia, Zhulei, Yu Kelong, Song Xiushan.
Accessory Devices for Sterile Single-use Intravascular
Catheters - Part 1: Introducers
1 Scope
This Part of YY 0450 specifies the requirements for single-use introducer needles, introducer catheters, sheath introducers, guidewires and dilators supplied in the sterile condition and used in conjunction with intravascular catheters specified in YY 0285. This Standard is applicable to single-use introducer needles, introducer catheters, sheath introducers, guidewires and dilators supplied in the sterile condition and used in conjunction with intravascular catheters specified in YY 0285.
NOTE: Appendix A provides a guideline for the materials and the design of these auxiliary devices.
2 Normative References
The following documents are indispensable to the application of this document. In terms of references with a specified date, only versions with a specified date are applicable to this document. In terms of references without a specified date, the latest version (including all the modifications) is applicable to this document. GB/T 1962.11) Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 1: General Requirement (GB/T 1962.1-2015, ISO 594-1:1986, IDT)
GB/T 1962.22) Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 2: Lock Fittings (GB/T 1962.2-2001, ISO 594- 2:1998, IDT)
GB/T 7408 Data Elements and Interchange Formats - Information Interchange - Representation of Dates and Times (GB/T 7408-2005, ISO 8601:2000, IDT)
GB 15810 Sterile Hypodermic Syringes for Single Use (GB 15810-2001, ISO 7886- 1:1993, IDT)
GB/T 16886.1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process (GB/T 16886.1-2011, ISO 10993-1: 2009, IDT) 1) If ISO 80369-7 is converted into Chinese Standard, it will replace GB/T 1962.1 and GB/T 1962.2. 2) If ISO 803690-7 (TRANSLATOR NOTE: it shall be ISO 80369-7) is converted into Chinese Standard, it will replace GB/T 1962.1 and GB/T 1962.2.
YY/T 0466.1 Medical Devices - Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied - Part 1: General Requirements (YY/T 0466.1- 2016, ISO 15223-1:2012, IDT)
YY/T 0586-2016 Medical Polymer Products - X-ray Permeability Test Method 3 Terms and Definitions
The following terms and definitions are applicable to this document.
NOTE: Figure 1, Figure 2, Figure 3 and Figure 4 provide graphic examples of medical devices described in this Part, and examples of the terms.
3.1 Coil (of a guidewire)
Coil of a guidewire refers to a metal wire wound in a spiral.
3.2 Core Wire (of a guidewire)
Core wire of a guidewire refers to a metal wire used to facilitate guidewire to reach a certain rigidity.
3.3 Dilator
Dilator refers to a flexible tubular device used to expand the percutaneous puncture channel into the blood vessel.
3.4 Distal End
Patient End
Distal end refers to one end of a medical device that is inserted into patient’s body. 3.5 Effective Length
Effective length refers to the length of a medical device that can be inserted into patient’s body.
3.6 Guidewire
Guidewire refers to a flexible medical device that guides a catheter or dilator (3.3) into the blood vessel and positions it.
NOTE: Figure 3 provides examples of the types of guidewire.
3.7 Hub
Hub refers to the connecting piece of the proximal end of intravascular catheter

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