This standard is equivalent to the international standard ISO 9585:1990 "Surgical implants - Determination of bending strength and stiffness of bone plates" (English version). It is completely equivalent to the international standard in terms of technical content. This standard specifies the method for determining the bending strength and stiffness of straight bone plates. It includes terms and definitions, instruments and equipment, test procedures, result calculation, and inspection report. This standard is applicable to straight bone plates, straight plate portions of bone plates with a certain angle, and bone plates with a small initial curvature in order to preload the bone during installation. This standard does not apply to bone plates less than 50 mm in length, nor does it apply to bone plates designed to be used with or become part of intramedullary devices. YY/T 0342-2002 Determination of bending strength and stiffness of surgical implant bone plates YY/T0342-2002 Standard download decompression password: www.bzxz.net

1CS *1. 040. 40
Pharmaceutical Industry Standard of the People's Republic of China
YY/T 0342—2002
Implants for surgery --Determination of bending strength and stiffness of bone plates(IS0 9585:1990,IL)T:
2002-09-24Promulgated
State Food and Drug Administration
2003-04-01Implementation
Terminology and meaning
Only equipment
Test steps
Result calculation
Inspection report
YY/T 0342- 2002
YY/T 0342-2002
This standard is equivalent to the international standard S) 931900 Determination of strength and stiffness of surgical implant plates. The content of the standard is completely equivalent to the international standard. This standard is issued by the National Drug Administration and approved by the Committee for the Reform of Standardization of Surgical Implants and Orthodontic Devices (CSTS/TC11). The drafting unit of this standard: National Drug Administration Medical Device Quality Supervision and Inspection Center. The main drafters of this standard: Wei, Xingfeng, Zhang Wenzhong. 1 Scope
Determination of bending strength and
stiffness of surgical implant plates
YY/I03422902
This standard specifies the determination method of bending strength and
stiffness of straight bone plates, including terms and definitions, device preparation, test procedures, result calculation, and inspection report. www.bzxz.net
The standard is suitable for straight joints with a solid angle and a straight part to create a small initial deformation in order to increase the preload after installation.
This standard does not apply to joint plates with a length less than 1mm, nor is it suitable for joint plates that are used together with a cover to form a backing plate with a spacing of 1/4" (partial).\
2 Definitions
This standard uses the following definitions.
torch momen
force furnace only, one is dyed · one auxiliary transfer station effect, mathematical expression fire to go (with the shallow city minister from the axis of the force. Unit; ·\
moment M.bendingmomen
force short along the fan industry has two objects described long axis medicine pumping on the fraud and on the production of cattle lateral movement, state for the production! Unit ·.
spelling deflertion
out of the ten bends before the linear distance generated by the initial axis of the mother pole you squeezed single him m.
snow curve strong hending The strength
is the breaking point or the specified point in the specification, which is the smallest bending strength, unit N, a
equivalent bending strength equivalent hendinstitfness can be calculated based on the external dimensions of the workpiece and the primary design to reach the agreed load equivalence
unit N·
1) After the length is determined, the starting rate is small,
2) This equivalent bending strength is calculated based on the linear part of the inclined center of the connection YY/TQ342—2C02
3 Instruments and equipment
3.1 Test apparatus
The micro-system shown in Figure 1 is a small structure with a vertical axis ( The belt should be fixed and its axis should be kept in line.
3.2 Roller
lifts various objects, such as the control--13m range, with a close outer garment and an average diameter within the range of -13m: one of the rollers is required to fix the sample to limit its movement, and all the requirements are required to maintain their relative strength: 3.3 Loading method
A material testing machine can be used to apply loading. 3.4 Measure its
with a device for displacement:
4 Test step
4.1 Sailing
Use the device specified in Chapter 3 to verify the adjustment. Used to measure the shape of the vehicle and replace the two bending points of the two grids, and the two grids are placed in the middle of the bending point, and the two grids are moved. Be careful of the height of the bent plate cabinet. The height of the plate exceeds 6 (the degree of competition of the press plate). Use the appropriate shape to test the plate. 2.2 Placement of the test specimens Place the test specimens according to the method of the H reverse method in the test site. Place or connect the two inner plates so that the two inner plates are in contact with each other. (a) The plate is symmetrical. Place the center screw hole close to the center axis of the product. If the center screw hole and another adjacent screw hole are symmetrically placed between the two inner plates, if the fracture is not symmetrical, place the two screw holes between the two inner plates. Make sure that the fracture is not symmetrical. Place the two screw holes between the two inner plates. Make sure that the fracture is not symmetrical. t||The two auxiliary shafts are placed in a suitable position with the inner and outer limit shafts (1) (as shown in Figure 1). Make sure that there is only one inner limit shaft and the outer limit shaft in length. Make sure that the two inner grips do not contact the part of the plate with screw holes, as far as possible, and the inner and outer limit shafts do not contact the part of the vehicle end.
Verify that the two side islands are straight with the axis of the shaft. The most accurate test product is the one that can be installed with the most effective measurement technology. The outer limit shaft can be pulled at the starting position to check the degree (m) of the installation product. The corresponding control volume can be measured, or 3 years of measurement data shaft! 1. For the tax number list, etc., the test force must be measured, and the concept is: the test force F shall be added at the center of the connection plate and the force may be asymmetric around the sound board (4.3 test force F): || tt || indicates the test force on the center of the load line, and the measurement shall be estimated. The value of the total force under the continuous increase of the river, remember to find each time interval between the two work should be selected medical drawing "a large tree season standard mountain cable diagram, the first to autumn or test the connection and the plate fracture when the lower value F production.. or a piece of grid plate selection or load a potential diagram to give the actual service point when the hundred F-user. As shown in Figure 2 4.4 Use of the test
can only make a test at the same time and then report the results of the calculation wing
5.1 Average flexural quotient
Figure 1 The relative position of the roller and the bone plate of the test point 28
Figure 2 or a
a disturbance curve
its blood. 23 The appropriate calculation formula for each test is nt +,
with the square production as the mathematical standard, with the flat driving express car standard typical diagram, 5.2 Equivalent bending stiffness
YYT D342—2002
Draw a true line as shown in the figure! Or select a thick picture to start the money shape of the card, such as the quality of the bird, then the formula (1> calculate the effective bending stiffness of the sheet: 3
YY/T 0342—2002
Wu Zhong:
（+12h±)h
The distance between the inner side and the outer side, in meters (m): *The distance between the inner side and the outer side, in meters (m) S--load rate. Units are Newton/meter·m), if the elasticity described in 1.2i)2) or 4.21>3) is also used, then the equivalent bending degree E is calculated by formula (2) (2jin+15jin
5.3 World bending strength
On the curve diagram, the parallel curve or line increase part or the horizontal part of the opposite curve is as shown in the figure. The intersection point of the straight line is used as the load point, and the load corresponding to this point is defined as the load direction formula:
(2(2h+ )
Formula 4) Calculate the bending strength (m: bending strain -9.5
-load unit item):
The internal and external loads of the four quotients, the unit is meter! The four joints of the East dry load
Dig monitoring bending load and change the standard phase change bacteria cattle break observation, the formula (5) calculates the bending strength, =
-maximum load, the single stand is the Newton recovery;
-the separation between the inner and outer energy, the unit is meter (). 6 Inspection and monitoring Report
Test report includes the following contents:
.Li Shan Degree: Niu Shen: To;
) Used to confirm the horizontal return (light) direction of the stock point) 2 The same variable curve Niu Qi\)
If the bone plate crown pad reaches the front crack, the bottom record to; ds
-) According to the characteristics of the plate, such as the model, length, production number, batch number, etc. of the bone plate, the unit of the test is required to provide. The flow method requires the collection of four limits, the enjoyment of 8 anti-personnel section 4
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