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YY/T 1697-2020: Test method for determining strength and setting time for synthetic water-activated polyurethane fiberglass casting tape
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| YY/T 1697-2020 | English | 149 |
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Test method for determining strength and setting time for synthetic water-activated polyurethane fiberglass casting tape
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YY/T 1697-2020
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Basic data | Standard ID | YY/T 1697-2020 (YY/T1697-2020) | | Description (Translated English) | Test method for determining strength and setting time for synthetic water-activated polyurethane fiberglass casting tape | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C48 | | Classification of International Standard | 11.140.01 | | Word Count Estimation | 8,836 | | Date of Issue | 2020 | | Date of Implementation | 2021-01-01 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies a test method for determining the radial compressive strength and curing time of annular specimens made of synthetic water-activated polyurethane fiberglass orthopedic bandages. This standard applies to synthetic water-activated polyurethane fiberglass orthopedic bandages. | YY/T 1697-2020: Test method for determining strength and setting time for synthetic water-activated polyurethane fiberglass casting tape
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Test method for determining strength and setting time for synthetic water-activated polyurethane fiberglass casting tape
ICS 11.140.01
C48
People's Republic of China Pharmaceutical Industry Standard
Synthetic water activated polyurethane fiberglass orthopedic bandage
Test method for determination of strength and curing time
2020-02-21 released
2021-01-01 implementation
Issued by the State Drug Administration
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
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 standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of Shandong Medical Device Product Quality Inspection Center.
Drafting organizations of this standard. Nanjing Sunway Biomedical Technology Co., Ltd., Shandong Medical Device Product Quality Inspection Center, National Glass
Fiber Product Quality Supervision and Inspection Center.
The main drafters of this standard. Chen Cheng, Zhang Xining, Liang Jinkui, Fang Yunwei, Chen Tian.
Introduction
Synthetic water activated polyurethane fiberglass orthopedic bandage is a representative product of polymer fixation bandage, suitable for orthopedics, plastic surgery and first
The external fixation of fractures and sprains in general surgery is widely used in clinical practice.
Synthetic water activated polyurethane fiberglass orthopedic bandage
Test method for determination of strength and curing time
1 Scope
This standard specifies the determination of the radial compressive strength and curing of annular specimens made of synthetic water-activated polyurethane fiberglass orthopedic bandages
Time test method.
This standard applies to synthetic water activated polyurethane fiberglass orthopedic bandages.
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 6682 Analytical laboratory water specifications and test methods
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Radial compression strength
The load per unit width after the ring sample is compressed in the radial direction (perpendicular to the axis of the ring sample).
Note. The unit is Newton per millimeter (N/mm).
3.2
Peak failure load
Before the radial deformation reaches a displacement of 10mm, the specimen is broken and accompanied by a decrease in the load value, which is measured before the load value decreases.
Maximum load.
3.3
Maximum deflection load
The ring specimen is compressed from the position when the force is initially applied and undergoes a displacement of 10mm, and there is no obvious damage or no measured load reduction.
Load.
4 Method overview
4.1 Immerse the intercepted orthopedic bandage in (24±1)℃ water, drain it out, and wrap it on a cylindrical shaft tube with an outer diameter of 75mm.
Wrap the bandage layer by layer to form a 5-layer ring sample. The indentation test is used to determine the curing time. After the ring sample is initially cured
Remove from the shaft tube. After the specified time of 30min, 60min, and 24h, place the ring sample laterally on the two flat platforms of the testing machine
The plates are compressed radially to determine their strength.
4.2 The radial compressive strength is an important indicator of the mechanical properties of solidified materials.
Note. This test method cannot be used to determine the life of the tested material, bending of the fixed material or other failure modes.
5 Apparatus and materials
5.1 Universal testing machine
5.1.1 The relative error of the universal testing machine load should not exceed ±1%.
5.1.2 A constant test speed can be obtained.
5.1.3 The relative error of deformation measurement should not exceed ±1%.
5.1.4 The universal testing machine should have a flat platen for compression testing, and the surface of the flat platen must be perpendicular to the load axis.
Must always be parallel.
5.2 Winding device
5.2.1 The winding device includes a sample preparation shaft tube and a winding motor. The sample preparation shaft tube is a rigid cylindrical shaft tube with an outer diameter of 75mm installed horizontally.
The length should be long enough to wrap the two ring specimens whose ends do not touch each other (see Figure 1). It is also possible to use multiple shaft tubes to make a sample on each shaft tube.
5.2.2 The winding motor is a device that can make the shaft tube obtain a constant rotating speed and an adjustable speed.
Figure 1 Winding device
5.3 Water container
The capacity and depth of the water container should be sufficient for the orthopedic band to be completely immersed in water.
5.4 Anti-stick lining
The anti-sticking lining is a sheet-like film with a nominal thickness (such as a polyethylene film with a thickness of 30 μm), which is used to cover the surface of the shaft tube to prevent trees
Grease adheres to the shaft tube. The anti-sticking lining should enable the cured sample to be easily removed from the shaft tube, and it can be used before the compression strength test.
Easily remove from the inner wall of the specimen.
5.5 Timer
The accuracy of the timer is ±1s.
5.6 Gloves
Gloves that can prevent hand contact with resin, such as latex gloves. Used to prevent the operator from contacting the uncured or cured resin to prevent
The resin may adhere to the skin and is difficult to remove, and it can also prevent the isocyanate contained in most polyurethane resins from making some operators suffer.
Because of its sensitization. Always wear gloves when handling uncured or cured samples.
5.7 Thermometer
The thermometer should be able to measure the temperature from 20°C to 30°C with an accuracy of ±0.5°C.
5.8 Push-pull force gauge
The instrument that can detect the pressing force value has a range of 100N and has the wedge-shaped push head shown in Figure 2.
Figure 2 Schematic diagram of wedge-shaped push head
6 Samples and reagents
6.1 The orthopedic bandages of the same specification are from the same batch, and at least 5 rolls of orthopedic bandages are prepared for testing; each roll shall be carried out within the specified time
Ring sample preparation, each roll of orthopedic bandage can prepare 2 ring samples, and at least 9 ring samples can be prepared.
6.2 The water required to prepare the ring sample meets the requirements of GB/T 6682 tertiary water or above, and the immersion water temperature is maintained at (24 ±
1) ℃, after testing 5 rolls of orthopedic bandage, change the water used.
7 Status adjustment
Place the unopened orthopedic bandage flat in an environment with a temperature of (23 ± 2) ℃, and store it for at least 24h before the test.
8 Sample preparation and curing time detection
8.1 The ring sample adopts a constant tension sample preparation method, and each layer of bandage is wound on the shaft tube with a constant tension of 5.0g/mm (see Figure 1). will
The counterweight load is clamped on the unfolding end of the orthopedic belt while rotating the horizontal shaft tube.
8.2 Before opening each package, record the manufacturer's name, product specifications, size (width and length) and batch number. Orthopedic bandage open
It should be used immediately after packaging.
8.3 Wrap the anti-sticking lining on the shaft tube of the preparation sample and fix it with tape or other means.
8.4 Open the package, take out the orthopedic bandage, quickly unfold the orthopedic bandage, lay it flat and cut out the 1.2m~1.3m bandage, and place the intercepted orthopedic bandage.
The band is completely immersed in the water according to the instructions of the orthopedic bandage. After immersing in the water, start timing, quickly take out the soaked bandage, drain the excess water, and wrap one end on the shaft
On the tube, the winding length should be less than or equal to the circumference of the shaft tube and should be able to keep the bandage from falling off. Clamp the clamp and the weight on the other orthopedic bandage.
At the end, the direction in which the bandage falls should be perpendicular to the axis of rotation of the shaft tube, adjust the winding device to 20r/min, turn on the switch to rewind, and keep
Each layer completely overlaps the previous layer. When the bandage is wound to the end of the fifth layer, at ±5mm relative to the starting end of the first layer
Cut off the excess bandage.
8.5 Repeat 8.4 to make a second ring sample immediately.
8.6 The winding production of multiple circular specimens can be performed at the same time. When multiple circular specimens are wound, the
The belt should be soaked and taken out at the same time.
8.7 The curing time is measured by the indentation test method. A push-pull dynamometer with a wedge-shaped pusher is used for the ring sample to be perpendicular to the
The indentation test is carried out on the contact surface of the ring sample, and the test is carried out every 15s until all samples are cured (no obvious indentation). Record 9 rings
Calculate the curing time of the shaped sample from the time the sample is immersed in water, and record the average value as the curing time.
8.8 After the ring sample is cured, remove it from the shaft tube and avoid deformation of the sample. Remove the release liner from the inner wall of the ring sample.
8.9 Place the ring specimens vertically and keep enough space between the specimens so that air can circulate freely between the ring specimens.
9 Radial compression strength test
9.1 Test speed
The testing machine performs the compression test at a constant speed of 20 mm/min.
9.2 30min radial compression strength
9.2.1 This test shall be carried out after (30 ± 5) minutes have passed after the intercepted orthopedic bandage sample is immersed in water. Place each sample (one at a time) in
Between the two flat platens of the testing machine, place it at the center of the lower platen. The length of the platen should be large enough to support the entire length
sample. Adjust the direction of the ring sample so that the transition area or overlap area of the sample, that is, the part between the beginning of the first layer and the end of the fifth layer, and the lower
The platen touches.
Note. Due to the fact that the number of layers in the transition area increases or decreases relative to the fixed number of layers in other areas, there is an overlap between the first and fifth layers
Or missing will affect the strength of the transition zone. The failure of the sample usually occurs in the high tensile stress area on the outer wall of the ring sample, so avoid overlapping areas
The domain or transition zone is in a zone of high tensile stress.
9.2.2 Make the upper platen just contact the ring sample, but do not apply any load.
9.2.3 Continue the test at a uniform rate until the ring sample is damaged or compressed after a 10mm displacement, stop the compression test.
9.2.4 If the sample is not cured within 30min, there is no need to test the 30min radial compressive strength.
9.2.5 Record the maximum load of each ring specimen, that is, the peak failure load or the maximum deflection load, whichever occurs first. 30min
The radial compressive strength is the average value calculated from the test values of 3 ring specimens.
9.3 60min radial compression strength
The test method is the same as the 30min radial compressive strength test, and the test is carried out at (60±5)min after the sample is immersed in water.
9.4 24h radial compression strength
The test method is the same as the 30min radial compressive strength test, and the test is carried out 24h±30min after the sample is immersed in water. Sample
During the 24h curing period, it should be stored at (23±2)℃ and (50±10)% relative humidity.
10 report
The test report should include at least the following.
a) Curing time in seconds (s);
b) Test speed, the loading speed of the testing machine when testing the radial compressive strength, in millimeters per minute (mm/min);
c) 30min, 60min, 24h radial compressive strength, the unit is Newton per millimeter (N/mm). Report the type of load (peak damage
Load or maximum deflection load);
d) Laboratory environment temperature and humidity.
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