YY 0450.1-2020_English: PDF (YY0450.1-2020)
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Accessory devices for sterile single-use intravascular catheters--Part 1: Introducers
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Standard ID | YY 0450.1-2020 (YY0450.1-2020) | 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 | C31 | Classification of International Standard | 11.040.25 | Word Count Estimation | 29,227 | Date of Issue | 2020 | Date of Implementation | 2021-08-01 | Summary | This standard specifies the requirements for single-use puncture needles, guide cannulas, catheter sheaths, guide wires and dilators supplied in a sterile state for use with intravascular catheters that meet the requirements of YY 0285. This standard applies to single-use puncture needles, guide cannulas, catheter sheaths, guide wires and dilators supplied in a sterile state for use with intravascular catheters that meet the requirements of the YY 0285 standard. This standard replaces YY 0450.1-2003 "Disposable Sterile Intravascular Catheter Accessories Part 1: Guiding Devices". | 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 0450.1-2020
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
......
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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