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YY 0450.1-2020: Accessory devices for sterile single-use intravascular catheters--Part 1: Introducers
YY 0450.1-2020
Accessory devices for sterile single-use intravascular catheters--Part 1.Introducers
ICS 11.040.25
C31
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0450.1-2003
Sterile intravascular catheter accessories for single use
Part 1.Guidance Device
2020-02-25 released
2021-08-01 implementation
Issued by the State Drug Administration
Table of contents
Preface Ⅲ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 General requirements 5
4.1 Sterilization 5
4.2 Biocompatibility 5
4.3 Surface 5
4.4 Corrosion resistance 5
4.5 Radiodetectability 5
4.6 Information provided by the manufacturer 5
5 Additional requirements for puncture needles 5
5.1 General 5
5.2 Specification label 6
5.3 Tip 6
5.4 Seat 6
5.4.1 Cone joint 6
5.4.2 Connection strength of needle tube and needle seat 6
5.5 Information provided by the manufacturer 6
6 Additional requirements for guide sleeve 6
6.1 General 6
6.2 Headend 6
6.3 Peak pull 6
6.4 Seat 6
6.5 Specification Mark 7
6.6 Information provided by the manufacturer 7
7 Additional requirements for catheter sheath 7
7.1 General 7
7.2 Specification marking 7
7.3 No leakage in the catheter sheath 7
7.4 No leakage from the hemostatic valve 8
7.5 Seat 8
7.6 Peak tension 8
7.7 Information provided by the manufacturer 8
8 Additional requirements for guide wire 8
8.1 General 8
8.2 Specification Mark 8
8.3 Safety thread 8
8.4 Burst test 8
8.5 Bend test 8
8.6 Peak guide wire pull 8
8.7 Information provided by the manufacturer 9
9 Additional requirements for expanders 9
9.1 General 9
9.2 Specification label 9
9.3 Seat 9
9.3.1 General 9
9.3.2 Cone joint 9
9.3.3 The connection strength between the base and the expander 9
9.4 Information provided by the manufacturer 9
10 Additional requirements for complete sets containing devices specified in this section 9
11 Connection strength test of needle tube and needle seat of puncture needle 10
Appendix A (informative appendix) Materials and Design 11
Appendix B (Normative Appendix) Corrosion Resistance Test Method 12
Appendix C (Normative appendix) Method for measuring peak tension of guide sleeve, catheter sheath and dilator 13
Appendix D (Normative Appendix) Test method for liquid leakage under catheter sheath pressure 15
Appendix E (Normative Appendix) Test method for liquid leakage of catheter sheath hemostatic valve 17
Appendix F (Normative Appendix) Guidewire rupture test method 18
Appendix G (Normative Appendix) Guide wire bending failure test method 20
Appendix H (Normative Appendix) Method of Measuring Peak Guide Wire Tension 22
Appendix I (Normative Appendix) Determination of the strength of the connection between the needle seat and the needle tube 24
References 25
Figure 1 Example of guide cannula and puncture needle 3
Figure 2 Example of catheter sheath and dilator 3
Figure 3 Guide wire example 4
Figure 4 Example of puncture needle tip and guide cannula tip 7
Figure D.1 Catheter sheath liquid leakage test device 16
Figure F.1 Guide wire rupture test device 19
Figure G.1 Guide wire bending performance test device 21
Figure H.1 Example of wedge-shaped opening fixture 23
Table 1 Identification of the nominal size of the puncture needle and the guide sleeve 6
Table 2 Peak tensile force of the test section of the guide sleeve, catheter sheath and dilator 7
Table 3 Peak guide wire pull 9
Table 4 Dimensions to be given for the complete combination 10
Preface
Part of 6.2 of this section is recommended, and the rest is mandatory.
YY 0450 "Disposable Sterile Intravascular Catheter Accessories" consists of the following parts.
---Part 1.Guiding equipment;
---Part 2.trocar peripheral catheter tube plug;
---Part 3.Balloon inflation device for balloon dilatation catheter.
This part is part 1 of YY 0450.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
This section replaces YY 0450.1-2003 "Disposable Sterile Intravascular Catheter Accessories Part 1.Guiding Devices".
Compared with YY 0450.1-2003, the main technical changes in this part are as follows except for editorial changes.
---Revised part of the requirements and test methods of the guide wire (see Chapter 8, see Chapter 8 of the.2003 edition);
---Revised the requirements for size identification (see 5.2, 6.5, 7.2, 8.2 and 9.2, see the.2003 edition of 5.2, 6.5, 7.2, 8.2 and 9.2);
---Added Appendix I, the method of measuring the strength of the needle holder and the needle connection (see Appendix I);
This part uses the redrafting method to modify and adopt ISO 11070.2014 "Disposable Sterile Intravascular Catheter Guidance Device".
Compared with ISO 11070.2014, this part has structural differences. These differences and the reasons are as follows.
---Chapter 11 "Test of the connection strength of the needle tube and the needle seat of the puncture needle" is added, so that this chapter refers to Appendix I; at the same time, 5.4.2,
Make the article refer to Chapter 11.In order to meet the requirements of GB/T 1.1 for the order of the volume appendix of this part, it is consistent with ISO 11070.2014
Compared with no technical difference.
Compared with ISO 11070.2014, this part has technical differences. These differences and the reasons are as follows.
---Regarding normative reference documents, this section has made adjustments with technical differences to adapt to my country's technical conditions and adjustments.
The situation is collectively reflected in Chapter 2 "Normative Reference Documents", and the specific adjustments are as follows.
● Replace ISO 594-1 with GB/T 1962.1 which is equivalent to adopting international standards;
● Replace ISO 594-2 with GB/T 1962.2 which is equivalent to the international standard;
● Replace ISO 8601 with GB/T 7408 which is equivalent to adopting international standards;
● Replace ISO 7886-1 with GB 15810 which is equivalent to adopting international standards;
● Replace 10993-1 with GB/T 16886.1 which is equivalent to the international standard;
● Replace ISO 15223-1 with YY/T 0466.1 which is equivalent to the international standard;
● Replace ASTMF640-12 and DIN13273-7 with YY/T 0586-2016.
--- Regarding footnotes, this section has made adjustments with technical differences. The specific adjustments are as follows.
Modified footnote 1) and footnote 2) to adapt to current international and Chinese technical conditions.
Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
This part was proposed by the State Drug Administration.
This part is under the jurisdiction of the National Standardization Technical Committee for Medical Infusion Devices.
Drafting organizations of this section. Shandong Medical Device Product Quality Inspection Center, Lepu (Beijing) Medical Devices Co., Ltd., Medtronic
(Shanghai) Management Co., Ltd., Shanghai MicroPort Medical Equipment (Group) Co., Ltd., Shandong Weigao Group Medical Polymer Products Co., Ltd.
the company.
The main drafters of this section. Wan Min, Xu Jiajia, Zhu Lei, Yu Kelong, Song Xiushan.
The previous releases of the standards replaced by this part are.
---YY 0450.1-2003.
1 Scope
This part of YY 0450 specifies the one used together with the intravascular catheter that meets the requirements of the YY 0285 standard and is supplied in a sterile state.
Requirements for single use of puncture needles, guide sleeves, catheter sheaths, guide wires and dilators.
This part is applicable to single-use wearers that are used together with intravascular catheters that meet the requirements of the YY 0285 standard and are supplied in a sterile state.
Needle, guide sleeve, catheter sheath, guide wire and dilator.
Note. Appendix A gives the materials and design guidelines for these auxiliary devices.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 1962.11) Syringe, injection needle and other medical devices 6% (Luer) tapered joints Part 1.General requirements
(GB/T 1962.1-2015, ISO 594-1.1986, IDT)
GB/T 1962.22) Syringe, injection needle and other medical devices 6% (Luer) tapered joints Part 2.Locking joints
(GB/T 1962.2-2001, ISO 594-2.1998, IDT)
GB/T 7408 Data element and exchange format information exchange date and time representation (GB/T 7408-2005, ISO 8601.
2000, IDT)
GB 15810 Sterile syringe 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 in the Process of Risk Management (GB/T 16886.1-
2011, ISO 10993-1.2009, IDT)
YY/T 0466.1 Medical devices are used for medical device labeling, marking and information symbols. Part 1.General requirements
(YY/T 0466.1-2016,ISO 15223-1.2012,IDT)
YY/T 0586-2016 X-ray opacity test method for medical polymer products
3 Terms and definitions
The following terms and definitions apply to this document.
Note. Figure 1, Figure 2, Figure 3 and Figure 4 gives a legend of the device described in this section, and gives examples of terms.
4 General requirements
4.1 Sterilization
The device should be sterilized by a confirmed method, and the device should meet the requirements of 4.2~4.4 under aseptic conditions.
Note. For suitable sterilization methods, see the appropriate parts of ISO 17665, ISO 11135 and ISO 11137.
4.2 Biocompatibility
When tested according to the appropriate requirements in GB/T 16886.1, the device should be free of biological hazards.
4.3 Surface
When inspecting with normal vision or corrected vision under conditions of at least 2.5 times magnification, the outer surface of the effective length of the device should be free of impurities.
The outer surface of the effective length of the device, including the end, should be free of processing defects and surface defects that may damage the blood vessel during use.
If the intravascular catheter guiding device is coated with lubricant, the outer surface of the effective length of the device should not be seen when checking with normal or corrected vision.
Lubricant droplets to converge.
4.4 Corrosion resistance
When testing in accordance with the method given in Appendix B, if the metal parts of the device have visible corrosion marks that affect the performance, they should be evaluated
Corrosion level related to the intended use and risk assessment.
4.5 Radiodetectability
It is determined through risk assessment that, if necessary, a certain part of the guiding device should be radiographically detectable.
Its compliance should be verified by a suitable test method, such as YY/T 0586-2016.
4.6 Information provided by the manufacturer
The manufacturer shall provide at least the information listed in a)~i). All dimensions given should be expressed in SI units.
Other measurement units can also be used in addition.
If applicable, YY/T 0466.1 should be used.
The following is a description of the device.
a) Name or trade name and manufacturer's address;
b) Lot number (beginning with "LOT"), or serial number or appropriate symbol;
c) According to the expiration date or expiration date of GB/T 7408;
d) Any special storage and/or transportation instructions;
e) "Sterile" words or appropriate symbols;
f) Sterilization method;
g) Marks or appropriate symbols for single-use devices;
h) Any substance known to be incompatible with the use of the device;
i) Instructions and warnings (if applicable).
5 Additional requirements for puncture needles
5.1 General
The puncture needle should meet the requirements of Chapter 4.
5.2 Specification label
The nominal size of the puncture needle should be marked with the outer diameter, inner diameter and effective length shown in Table 1.
Table 1 The identification unit of the nominal size of the puncture needle and the guide sleeve is mm
5.3 Tip
When inspected under 2.5 times magnification, the needle tip should be sharp and free of burrs, burrs and hooks.
5.4 seats
5.4.1 Cone joint
If a needle holder is provided, the needle holder should have an inner circle with a 6% (Ruhr) taper that meets the requirements of GB/T 1962.1 and/or GB/T 1962.2
Cone connector.
5.4.2 Connection strength of needle tube and needle seat
When testing according to the method given in Chapter 11, a needle tube with a nominal outer diameter less than 0.6mm is applied with a force of 10N; the nominal outer diameter is equal to or greater than
The 0.6mm needle tube applies a force of 20N, and the connection between the needle tube and the needle seat should not be loose.
5.5 Information provided by the manufacturer
The manufacturer shall give the nominal size of the puncture needle required by 5.2.
6 Additional requirements for guide casing
6.1 General
The guiding sleeve shall meet the requirements of Chapter 4.
6.2 Headend
If equipped with a puncture needle, when the needle is fully inserted into the guide cannula, the bevel of the needle tip should fully extend from the tip of the cannula, and the root of the bevel of the needle
The distance from the end of the casing should not exceed 1 mm (see dimension a in Figure 4).
The end of the guide cannula should be designed to be easy to insert and cause minimal damage, and should fit tightly with the needle.
6.3 Peak tension
When testing in accordance with the method given in Appendix C, the peak tension of the guide sleeve and the connection between the guide sleeve and the seat should meet the requirements of Table 2.
6.4 seats
If there is a seat, there should be a 6% (Ruhr) taper inner conical joint on the seat in accordance with GB/T 1962.1 and/or GB/T 1962.2.
6.5 Specification label
The nominal size of the guide sleeve shall be marked with the outer diameter, inner diameter and effective length shown in Table 1.
6.6 Information provided by the manufacturer
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YY 0450.1-2020: Accessory devices for sterile single-use intravascular catheters--Part 1: Introducers
YY 0450.1-2020
Accessory devices for sterile single-use intravascular catheters--Part 1.Introducers
ICS 11.040.25
C31
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0450.1-2003
Sterile intravascular catheter accessories for single use
Part 1.Guidance Device
2020-02-25 released
2021-08-01 implementation
Issued by the State Drug Administration
Table of contents
Preface Ⅲ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 General requirements 5
4.1 Sterilization 5
4.2 Biocompatibility 5
4.3 Surface 5
4.4 Corrosion resistance 5
4.5 Radiodetectability 5
4.6 Information provided by the manufacturer 5
5 Additional requirements for puncture needles 5
5.1 General 5
5.2 Specification label 6
5.3 Tip 6
5.4 Seat 6
5.4.1 Cone joint 6
5.4.2 Connection strength of needle tube and needle seat 6
5.5 Information provided by the manufacturer 6
6 Additional requirements for guide sleeve 6
6.1 General 6
6.2 Headend 6
6.3 Peak pull 6
6.4 Seat 6
6.5 Specification Mark 7
6.6 Information provided by the manufacturer 7
7 Additional requirements for catheter sheath 7
7.1 General 7
7.2 Specification marking 7
7.3 No leakage in the catheter sheath 7
7.4 No leakage from the hemostatic valve 8
7.5 Seat 8
7.6 Peak tension 8
7.7 Information provided by the manufacturer 8
8 Additional requirements for guide wire 8
8.1 General 8
8.2 Specification Mark 8
8.3 Safety thread 8
8.4 Burst test 8
8.5 Bend test 8
8.6 Peak guide wire pull 8
8.7 Information provided by the manufacturer 9
9 Additional requirements for expanders 9
9.1 General 9
9.2 Specification label 9
9.3 Seat 9
9.3.1 General 9
9.3.2 Cone joint 9
9.3.3 The connection strength between the base and the expander 9
9.4 Information provided by the manufacturer 9
10 Additional requirements for complete sets containing devices specified in this section 9
11 Connection strength test of needle tube and needle seat of puncture needle 10
Appendix A (informative appendix) Materials and Design 11
Appendix B (Normative Appendix) Corrosion Resistance Test Method 12
Appendix C (Normative appendix) Method for measuring peak tension of guide sleeve, catheter sheath and dilator 13
Appendix D (Normative Appendix) Test method for liquid leakage under catheter sheath pressure 15
Appendix E (Normative Appendix) Test method for liquid leakage of catheter sheath hemostatic valve 17
Appendix F (Normative Appendix) Guidewire rupture test method 18
Appendix G (Normative Appendix) Guide wire bending failure test method 20
Appendix H (Normative Appendix) Method of Measuring Peak Guide Wire Tension 22
Appendix I (Normative Appendix) Determination of the strength of the connection between the needle seat and the needle tube 24
References 25
Figure 1 Example of guide cannula and puncture needle 3
Figure 2 Example of catheter sheath and dilator 3
Figure 3 Guide wire example 4
Figure 4 Example of puncture needle tip and guide cannula tip 7
Figure D.1 Catheter sheath liquid leakage test device 16
Figure F.1 Guide wire rupture test device 19
Figure G.1 Guide wire bending performance test device 21
Figure H.1 Example of wedge-shaped opening fixture 23
Table 1 Identification of the nominal size of the puncture needle and the guide sleeve 6
Table 2 Peak tensile force of the test section of the guide sleeve, catheter sheath and dilator 7
Table 3 Peak guide wire pull 9
Table 4 Dimensions to be given for the complete combination 10
Preface
Part of 6.2 of this section is recommended, and the rest is mandatory.
YY 0450 "Disposable Sterile Intravascular Catheter Accessories" consists of the following parts.
---Part 1.Guiding equipment;
---Part 2.trocar peripheral catheter tube plug;
---Part 3.Balloon inflation device for balloon dilatation catheter.
This part is part 1 of YY 0450.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
This section replaces YY 0450.1-2003 "Disposable Sterile Intravascular Catheter Accessories Part 1.Guiding Devices".
Compared with YY 0450.1-2003, the main technical changes in this part are as follows except for editorial changes.
---Revised part of the requirements and test methods of the guide wire (see Chapter 8, see Chapter 8 of the.2003 edition);
---Revised the requirements for size identification (see 5.2, 6.5, 7.2, 8.2 and 9.2, see the.2003 edition of 5.2, 6.5, 7.2, 8.2 and 9.2);
---Added Appendix I, the method of measuring the strength of the needle holder and the needle connection (see Appendix I);
This part uses the redrafting method to modify and adopt ISO 11070.2014 "Disposable Sterile Intravascular Catheter Guidance Device".
Compared with ISO 11070.2014, this part has structural differences. These differences and the reasons are as follows.
---Chapter 11 "Test of the connection strength of the needle tube and the needle seat of the puncture needle" is added, so that this chapter refers to Appendix I; at the same time, 5.4.2,
Make the article refer to Chapter 11.In order to meet the requirements of GB/T 1.1 for the order of the volume appendix of this part, it is consistent with ISO 11070.2014
Compared with no technical difference.
Compared with ISO 11070.2014, this part has technical differences. These differences and the reasons are as follows.
---Regarding normative reference documents, this section has made adjustments with technical differences to adapt to my country's technical conditions and adjustments.
The situation is collectively reflected in Chapter 2 "Normative Reference Documents", and the specific adjustments are as follows.
● Replace ISO 594-1 with GB/T 1962.1 which is equivalent to adopting international standards;
● Replace ISO 594-2 with GB/T 1962.2 which is equivalent to the international standard;
● Replace ISO 8601 with GB/T 7408 which is equivalent to adopting international standards;
● Replace ISO 7886-1 with GB 15810 which is equivalent to adopting international standards;
● Replace 10993-1 with GB/T 16886.1 which is equivalent to the international standard;
● Replace ISO 15223-1 with YY/T 0466.1 which is equivalent to the international standard;
● Replace ASTMF640-12 and DIN13273-7 with YY/T 0586-2016.
--- Regarding footnotes, this section has made adjustments with technical differences. The specific adjustments are as follows.
Modified footnote 1) and footnote 2) to adapt to current international and Chinese technical conditions.
Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
This part was proposed by the State Drug Administration.
This part is under the jurisdiction of the National Standardization Technical Committee for Medical Infusion Devices.
Drafting organizations of this section. Shandong Medical Device Product Quality Inspection Center, Lepu (Beijing) Medical Devices Co., Ltd., Medtronic
(Shanghai) Management Co., Ltd., Shanghai MicroPort Medical Equipment (Group) Co., Ltd., Shandong Weigao Group Medical Polymer Products Co., Ltd.
the company.
The main drafters of this section. Wan Min, Xu Jiajia, Zhu Lei, Yu Kelong, Song Xiushan.
The previous releases of the standards replaced by this part are.
---YY 0450.1-2003.
1 Scope
This part of YY 0450 specifies the one used together with the intravascular catheter that meets the requirements of the YY 0285 standard and is supplied in a sterile state.
Requirements for single use of puncture needles, guide sleeves, catheter sheaths, guide wires and dilators.
This part is applicable to single-use wearers that are used together with intravascular catheters that meet the requirements of the YY 0285 standard and are supplied in a sterile state.
Needle, guide sleeve, catheter sheath, guide wire and dilator.
Note. Appendix A gives the materials and design guidelines for these auxiliary devices.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 1962.11) Syringe, injection needle and other medical devices 6% (Luer) tapered joints Part 1.General requirements
(GB/T 1962.1-2015, ISO 594-1.1986, IDT)
GB/T 1962.22) Syringe, injection needle and other medical devices 6% (Luer) tapered joints Part 2.Locking joints
(GB/T 1962.2-2001, ISO 594-2.1998, IDT)
GB/T 7408 Data element and exchange format information exchange date and time representation (GB/T 7408-2005, ISO 8601.
2000, IDT)
GB 15810 Sterile syringe 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 in the Process of Risk Management (GB/T 16886.1-
2011, ISO 10993-1.2009, IDT)
YY/T 0466.1 Medical devices are used for medical device labeling, marking and information symbols. Part 1.General requirements
(YY/T 0466.1-2016,ISO 15223-1.2012,IDT)
YY/T 0586-2016 X-ray opacity test method for medical polymer products
3 Terms and definitions
The following terms and definitions apply to this document.
Note. Figure 1, Figure 2, Figure 3 and Figure 4 gives a legend of the device described in this section, and gives examples of terms.
4 General requirements
4.1 Sterilization
The device should be sterilized by a confirmed method, and the device should meet the requirements of 4.2~4.4 under aseptic conditions.
Note. For suitable sterilization methods, see the appropriate parts of ISO 17665, ISO 11135 and ISO 11137.
4.2 Biocompatibility
When tested according to the appropriate requirements in GB/T 16886.1, the device should be free of biological hazards.
4.3 Surface
When inspecting with normal vision or corrected vision under conditions of at least 2.5 times magnification, the outer surface of the effective length of the device should be free of impurities.
The outer surface of the effective length of the device, including the end, should be free of processing defects and surface defects that may damage the blood vessel during use.
If the intravascular catheter guiding device is coated with lubricant, the outer surface of the effective length of the device should not be seen when checking with normal or corrected vision.
Lubricant droplets to converge.
4.4 Corrosion resistance
When testing in accordance with the method given in Appendix B, if the metal parts of the device have visible corrosion marks that affect the performance, they should be evaluated
Corrosion level related to the intended use and risk assessment.
4.5 Radiodetectability
It is determined through risk assessment that, if necessary, a certain part of the guiding device should be radiographically detectable.
Its compliance should be verified by a suitable test method, such as YY/T 0586-2016.
4.6 Information provided by the manufacturer
The manufacturer shall provide at least the information listed in a)~i). All dimensions given should be expressed in SI units.
Other measurement units can also be used in addition.
If applicable, YY/T 0466.1 should be used.
The following is a description of the device.
a) Name or trade name and manufacturer's address;
b) Lot number (beginning with "LOT"), or serial number or appropriate symbol;
c) According to the expiration date or expiration date of GB/T 7408;
d) Any special storage and/or transportation instructions;
e) "Sterile" words or appropriate symbols;
f) Sterilization method;
g) Marks or appropriate symbols for single-use devices;
h) Any substance known to be incompatible with the use of the device;
i) Instructions and warnings (if applicable).
5 Additional requirements for puncture needles
5.1 General
The puncture needle should meet the requirements of Chapter 4.
5.2 Specification label
The nominal size of the puncture needle should be marked with the outer diameter, inner diameter and effective length shown in Table 1.
Table 1 The identification unit of the nominal size of the puncture needle and the guide sleeve is mm
5.3 Tip
When inspected under 2.5 times magnification, the needle tip should be sharp and free of burrs, burrs and hooks.
5.4 seats
5.4.1 Cone joint
If a needle holder is provided, the needle holder should have an inner circle with a 6% (Ruhr) taper that meets the requirements of GB/T 1962.1 and/or GB/T 1962.2
Cone connector.
5.4.2 Connection strength of needle tube and needle seat
When testing according to the method given in Chapter 11, a needle tube with a nominal outer diameter less than 0.6mm is applied with a force of 10N; the nominal outer diameter is equal to or greater than
The 0.6mm needle tube applies a force of 20N, and the connection between the needle tube and the needle seat should not be loose.
5.5 Information provided by the manufacturer
The manufacturer shall give the nominal size of the puncture needle required by 5.2.
6 Additional requirements for guide casing
6.1 General
The guiding sleeve shall meet the requirements of Chapter 4.
6.2 Headend
If equipped with a puncture needle, when the needle is fully inserted into the guide cannula, the bevel of the needle tip should fully extend from the tip of the cannula, and the root of the bevel of the needle
The distance from the end of the casing should not exceed 1 mm (see dimension a in Figure 4).
The end of the guide cannula should be designed to be easy to insert and cause minimal damage, and should fit tightly with the needle.
6.3 Peak tension
When testing in accordance with the method given in Appendix C, the peak tension of the guide sleeve and the connection between the guide sleeve and the seat should meet the requirements of Table 2.
6.4 seats
If there is a seat, there should be a 6% (Ruhr) taper inner conical joint on the seat in accordance with GB/T 1962.1 and/or GB/T 1962.2.
6.5 Specification label
The nominal size of the guide sleeve shall be marked with the outer diameter, inner diameter and effective length shown in Table 1.
6.6 Information provided by the manufacturer
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