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Some contents of 6.2 of this standard is voluntary, and the rest are compulsory.
YY 0450 consists of the following parts under the general title Accessory devices for sterile single-use intravascular catheters:
——Part 1: Introducers;
——Part 2: Obturators for over-needle peripheral catheters;
——Part 3: Inflation devices for balloon of balloon dilatation catheters.
This is Part 1 of YY/T 0450.
This part is developed in accordance with the rules given in GB/T 1.1-2009.
This part replaces YY 0450.1-2003 Accessory devices for sterile single-use intravascular catheters — Part 1: Introducers.
In addition to a number of editorial changes, the following technical changes have been made with respect to YY 0450.1-2003:
——The partial requirements and test methods of guidewires are modified (see Clause 8; Clause 8 of 2003 edition);
——The requirements for size identification (see 5.2, 6.5, 7.2, 8.2 and 9.2; 5.2, 6.5, 7.2, 8.2 and 9.2 of 2003 edition);
——Annex I “Determination of strength of union of needle hub and needle” is added (see Annex I);
This part has been redrafted and modified in relation to ISO 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires.
The main structural differences of this part from ISO 11070:2014 and their justifications are as follows:
——Clause 11 "Strength of union of introducer needle tube and needle hub", is added, and Annex I is quoted hereto; 5.4.2 is modified and Clause 11 is quoted hereto, In order to meet the requirements of GB/T 1.1 for the sequence of annexes mentioned in this part, no technical differences have been made with respect to ISO 11070:2014.
The main technical differences of this part from ISO 11070:2014 and their justifications are as follows:
——the adjustments on technical differences are made for the normative references of this part to adapt to the technical conditions in China, which are mainly reflected in Clause 2 "Normative references”, with the following specific contents:
ISO 594-1 is replaced by GB/T 1962.1, which is identical to the international standard;
ISO 594-2 is replaced by GB/T 1962.2, which is identical to the international standard;
ISO 8601 is replaced by GB/T 7408, which is identical to the international standard;
ISO 7886-1 is replaced by GB 15810, which is identical to the international standard;
ISO 10993-1 is replaced by GB/T 16886.1, which is identical to the international standard;
ISO 15223-1 is replaced by YY/T 0466.1, which is identical to the international standard;
ASTM F640-12 and DIN 13273-7 are replaced by YY/T 0586-2016.
——The following adjustments to technical differences have been made in this part in terms of footnotes:
Footnote 1) and Footnote 2) are modified to adapt to the current international and Chinese technical conditions.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This part was proposed by the National Medical Products Administration of the People’s Republic of China.
This part is under the jurisdiction of National Technical Committee on Medical Syringes of Standardization Administration of China.
The previous edition of this part is as follows:
——YY 0450.1-2003.
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, guidewires, and dilators supplied in the sterile condition, and intended for single use in conjunction with intravascular catheters specified in YY 0285.
This part is applicable to introducer needles, introducer catheters, sheath introducers, guidewires, 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 following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
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 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)
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 — Test methods of radiopacity
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 Figure 1, Figure 2, Figure 3, and Figure 4.
3.1
coil (of a guidewire)
helically wound wire
3.2
core wire (of a guidewire)
wire used to achieve stiffness of the guidewire
3.3
dilator
flexible, tubular device used for dilating the percutaneous opening into a blood vessel
3.4
distal end
patient end
end of the device, which is inserted into the patient
3.5
effective length
length of the device that can be inserted into the body
3.6
guidewire
flexible device over which a catheter or dilator (3.3) is passed to assist in the insertion and location of the catheter or dilator into a blood vessel
Note 1 to entry: Examples of guidewire types are shown in Figure 3.
3.7
hub
connector(s) at the proximal end of the intravascular catheter introducer, which can either be integral with the introducer or be capable of being securely fitted to the proximal end of the introducer
3.8
introducer catheter
short, flexible tube which is introduced into a blood vessel, typically over an introducer needle, and through which a catheter or guidewire can be introduced after removal of the introducer needle
3.9
intravascular catheter introducer
device designed to be used in conjunction with an intravascular catheter to facilitate introduction into the vascular system
3.10
introducer needle
pointed, rigid tube through which a guidewire (3.6) or catheter can be introduced into a blood vessel
3.11
proximal end
free end
end of the device opposite the distal end (3.4)
3.12
safety wire (of a guidewire)
additional wire used to minimize the possibility of detachment of the tip
3.13
sheath introducer
flexible tube which is introduced into a blood vessel, typically over a dilator (3.3), and through which a guidewire or catheter can be introduced after removal of the dilator
3.14
tip
extremity of the distal end (3.4) of the device
a) Introducer catheter b) Introducer needle
Keys:
1——effective length;
2——distal end;
3——catheter;
4——catheter hub (optional);
5——introducer needle tube;
6——needle hub.
Figure 1 Example of an introducer catheter and an introducer needle
a) Sheath introducer
b) Dilator
c) Assembled device
Keys:
1——distal end;
2——sheath;
3——haemostasis valve (optional);
4——stopcock with Luer fitting;
5——sidearm;
6——sidearm connection (optional);
7——hub.
Figure 2 Example of a sheath introducer and a dilator
a) Fixed core guidewire with safety wire
b) Movable core guidewire with safety wire
c) Movable core ‘J’ guidewire with safety wire
d) Guidewire with full length polymer jacket
e) Mandrel guidewire with distal polymer jacket
f) Mandrel guidewire with distal coils
Keys:
1——safety wire;
2——core wire;
3——spring coil;
4——polymer jacket.
Figure 3 Examples of guidewires
4 General requirements
4.1 Sterilization
The device shall have been sterilized by a validated method, and shall comply with 4.2 to 4.4 in the sterile condition.
Note: See applicable part(s) of ISO 17665, ISO 11135, and ISO 11137 for appropriate methods of sterilization.
4.2 Biocompatibility
The device shall be free from biological hazard in accordance with appropriate testing under GB/T 16886.1.
4.3 Surface
When examined by normal or corrected-to-normal vision with minimum 2.5x magnification, the external surface of the effective length of the device shall appear free from extraneous matter.
The external surface of the effective length of the device, including the distal end, shall be free from process and surface defects, which could cause trauma to vessels during use.
If the intravascular catheter introducer is lubricated, the lubricant shall not be visible as drops of fluid on the external surface of the effective length of the device when the device is examined under normal or corrected-to-normal vision.
4.4 Corrosion resistance
When tested in accordance with the method given in Annex B, if metallic components of the device show visible signs of corrosion that can affect functional performance, the level of corrosion shall be evaluated with respect to intended use and risk assessment.
4.5 Radio-detectability
Parts of the device shall be radio-detectable if required as determined by the risk assessment.
Compliance should be demonstrated by an appropriate test method, such as YY/T 0586-2016.
4.6 Information to be supplied by the manufacturer
The manufacturer shall supply at least the information listed in a) to i). All dimensions given shall be expressed in SI units of measurement.
Units of other measurement systems can additionally be used.
Where appropriate, YY/T 0466.1 should be used.
The following are the descriptions of the device:
a) name or trade name and address of the manufacturer;
b) batch code, preceded by the word LOT, or the serial number or the appropriate symbol;
c) expiry date or use-by date expressed according to GB/T 7408;
d) any special storage and/or handling conditions;
e) the word STERILE or the appropriate symbol;
f) method of sterilization;
g) an indication that the device is for single use or the appropriate symbol;
h) any known incompatibilities with substances likely to be used with the device;
i) instructions for use and warnings, as appropriate.
5 Additional requirements for introducer needles
5.1 General
The introducer needle shall comply with Clause 4.
5.2 Size designation
The nominal size of the introducer needle shall be designated by the outside diameter, inside diameter, and the effective length as shown in Table 1.
Table 1 Designation of nominal size of introducer needles and introducer catheters
Dimensions in millimetres
Device diameter Outside diameter rounded up to nearest Inside diameter rounded down to nearest Effective length rounded to nearest
≥0.6 0.1 0.1 1.0
<0.6 0.05 0.05 1.0
5.3 Needle point
When examined under 2.5x magnification, the needle point shall appear sharp and free from feather edges, burrs, and hooks.
5.4 Hub
5.4.1 Conical fitting
If a hub is provided, the hub shall have a female 6 % (Luer) taper conical fitting complying with GB/T 1962.1 and/or GB/T 1962.2.
5.4.2 Strength of union of needle tube and needle hub
When tested by the method given in Clause 11, the union of the needle tube and the needle hub shall not be loosened by a force of 10 N for needles of nominal outside diameter of less than 0.6 mm or of 20 N for needles of nominal outside diameter of 0.6 mm or greater.
5.5 Information to be supplied by the manufacturer
The manufacturer shall give the nominal size of the introducer needle as designated in 5.2.
6 Additional requirements for introducer catheters
6.1 General
The introducer catheter shall comply with Clause 4.
6.2 Tip
If supplied with an introducer needle, when the needle is fully inserted into the introducer catheter, the catheter shall neither extend beyond the heel of the needle bevel nor be more than 1 mm from it (see Figure 4, dimension a).
The distal end of the introducer catheter should be designed for ease of insertion and minimum trauma, and should fit closely to the needle.
6.3 Peak tensile force
When tested in accordance with the method given in Annex C, the peak tensile force of the introducer catheter and the junction between the introducer catheter and the hub shall be as given in Table 2.
6.4 Hub
If a hub is provided, the hub shall have a female 6 % (Luer) taper conical fitting complying with GB/T 1962.1 and/or GB/T 1962.2.
Keys:
1——heel of bevel;
2——introducer catheter;
3——introducer needle.
Figure 4 Example of an introducer needle point and an introducer catheter tip
Table 2 Peak tensile force of introducer catheter, sheath introducer, and dilator test pieces
Smallest outside diameter
mm Minimum peak tensile force
N
≥0.550 and <0.750
≥0.750 and <1.150
≥1.150 and <1.850
≥1.850 3
5
10
15
Note: This part does not specify requirements for peak tensile force for introducer catheter, sheath introducer, and dilator test pieces of less than 0.55 mm outside diameter. These values are determined by the manufacturer based on risk assessment.
6.5 Size designation
The nominal size of the introducer catheter shall be designated by the outside diameter, inside diameter, and the effective length as shown in Table 1.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Sterilization
4.2 Biocompatibility
4.3 Surface
4.4 Corrosion resistance
4.5 Radio-detectability
4.6 Information to be supplied by the manufacturer
5 Additional requirements for introducer needles
5.1 General
5.2 Size designation
5.3 Needle point
5.4 Hub
5.4.1 Conical fitting
5.4.2 Strength of union of needle tube and needle hub
5.5 Information to be supplied by the manufacturer
6 Additional requirements for introducer catheters
6.1 General
6.2 Tip
6.3 Peak tensile force
6.4 Hub
6.5 Size designation
6.6 Information to be supplied by the manufacturer
7 Additional requirements for sheath introducers
7.1 General
7.2 Size designation
7.3 Freedom from leakage from sheath introducer
7.4 Freedom from leakage through haemostasis valve
7.5 Hub
7.6 Peak tensile force
7.7 Information to be supplied by the manufacturer
8 Additional requirements for guidewires
8.1 General
8.2 Size designation
8.3 Safety wire
8.4 Fracture test
8.5 Flexing test
8.6 Peak tensile force of guidewire
8.7 Information to be supplied by the manufacturer
9 Additional requirements for dilators
9.1 General
9.2 Size designation
9.3 Hub
9.3.1 General
9.3.2 Conical fitting
9.3.3 Strength of union between hub and dilator
9.4 Information to be supplied by the manufacturer
10 Additional requirements for kits containing combinations of devices specified in this part
11 Strength of union of introducer needle tube and needle hub
Annex A (Informative) Materials and design
Annex B (Normative) Test method for corrosion resistance
Annex C (Normative) Method for determining peak tensile force of introducer catheters, sheath introducers, and dilators
Annex D (Normative) Test method for liquid leakage from sheath introducers under pressure
Annex E (Normative) Test method for liquid leakage through haemostasis valves of sheath introducers
Annex F (Normative) Test method for fracture of guidewires
Annex G (Normative) Test method for resistance of guidewires to damage by flexing
Annex H (Normative) Method for determining peak tensile force of guidewires
Annex I (Normative) Determination of strength of union of needle hub and needle
Bibliography
Figure 1 Example of an introducer catheter and an introducer needle
Figure 2 Example of a sheath introducer and a dilator
Figure 3 Examples of guidewires
Figure 4 Example of an introducer needle point and an introducer catheter tip
Figure D.1 Apparatus for testing liquid leakage from sheath introducers
Figure F.1 Apparatus for testing guidewires for fracture
Figure G.1 Test rig for testing flexibility of guidewires
Figure H.1 Example of a split-tapered clamp
Table 1 Designation of nominal size of introducer needles and introducer catheters
Table 2 Peak tensile force of introducer catheter, sheath introducer, and dilator test pieces
Table 3 Peak tensile force of guidewires
Table 4 Dimensions to be given for kits
Table C.1 Examples of conditions for a 20 mm/(min·mm) strain rate
