| At present, our center could undertake kinds of implants for surgery including metallic bone plates, metallic bone screws, metallic intramedullary nailing systems, metal cor |
Notes to delivery implants for surgery and related products.
At present, our center could undertake kinds of implants for surgery including metallic bone plates, metallic bone screws, metallic intramedullary nailing systems, metal correctional nail, metal correctional stick, metal bone pins, metal nail of neck fixation of femur, metallic lockable intramedullary nail, metallic clip, orthopaedics clamp (scissor) and orthopaedics saw and so on. According to product standards, the sample delivery requirements of general project of such products are as follows:
|
Number |
Test items |
The quantity of samples |
The need for sample preparation by enterprise |
|
1 |
Chemical composition |
30g |
No |
|
2 |
Appearance |
10 |
No |
|
3 |
Size |
10 |
No |
|
4 |
Mechanical properties (if there is) |
3 |
No |
|
5 |
Corrosion resistance |
3 |
No |
|
6 |
Surface defects |
10 |
No |
|
7 |
Surface roughness |
10 |
No |
|
8 |
Hardness |
3 |
No |
|
9 |
Maximum torque and maximum fracture torsion angle(only for metallic bone screws) |
3 |
No |
|
10 |
Flexural strength and the equivalent bending stiffness(only for metallic bone plates) |
3 |
No |
|
11 |
Sterile (if there is) |
3 individually packaged |
No |
|
12 |
Ethylene oxide residues (if there is) |
2 individually packaged |
No |
|
/ |
Total sample quantities for full tests |
At least 20 and 30g for chemical composition |
/ |
Note: if the products for chemical composition test are imports (listed on approval documents), can provide the test reports of outside qualified third-party test agencies for reference.
(from Beijing Institute Of Medical Device Testing)