YY 0315-2023Wrought titanium and titanium alloy dental implant (English PDF)

5.1 Chemical properties

5.1.1 For dental implants without special surface treatment, according to the test in 6.1.1.1, the chemical composition of titanium and titanium alloy dental implants shall comply with the relevant provisions of GB/T 13810, ISO 5832-2, ISO 5832-3, ISO 5832-11, or ASTM F67, ASTM F136, ASTM F1295, and ASTM F1472 concerning the chemical composition of titanium and titanium alloy materials for surgical implants.

5.1.2 For dental implants with special surface treatment, the surface chemical composition shall comply with the detailed information provided by the manufacturer, as tested in 6.1.2.The chemical composition of the dental implant matrix, according to test in 6.1.1, shall comply with the relevant provisions of GB/T 13810, ISO 5832-2, ISO 5832-3, ISO 5832-11, or ASTM F67, ASTM F136, ASTM F1295, and ASTM F1472 concerning the chemical composition of titanium and titanium alloy materials for surgical implants.

5.2 Microstructure According to test in 6.2, the microstructure of the dental implant shall comply with the relevant provisions of

3.3.3.5 in GB/T 13810-2017.The grain size shall comply with the relevant provisions of

3.3.3.6 in GB/T 13810-2017.

5.3 Dimensions

5.3.1 Geometric dimensions of each part According to the test in 6.3.2.1, the length and diameter tolerances of the dental implant are ±

0.2 mm. Angular tolerances shall conform to the precision tolerance grades for angles specified in GB/T 1804.The cone angle shall conform to the specifications in Table 1.

5.3.2 Fit between dental implant and implant abutment

5.3.2.1 Fit at the implant connection According to the test in 6.3.2.2.1, the connection between the dental implant and the implant abutment shall fit well.

5.3.2.2 Clearance between dental implant and implant abutment According to the test in 6.3.2.2.2, the clearance between the dental implant and the implant abutment shall be <=

0.035 mm.

5.3.2.3 Thread deviation For dental implants with two- or multi-segment threaded connections, the thread designation, nominal diameter, pitch, tolerance grade, and tolerance zone position of the connection threads shall be provided. For example. M1.6×0.35-6H. For non-standard threads, the dimensions and tolerances of the threaded connection shall be provided, such as pitch, major diameter, pitch diameter, and minor diameter. According to the test in 6.3.2.2.3, the thread deviation shall conform to the provisions of the manufacturer.

5.4 Surface properties

5.4.1 Appearance According to the test in 6.4.1, the surface of the dental implant shall be free from macroscopic defects caused by processing, such as scratches, cracks, sharp edges, burrs, and rolled edges of the threaded joint; and free from foreign matter.

5.4.2 Surface defects According to the test in 6.4.2, the smooth surface of the dental implant shall not have discontinuous defects (such as pore inclusions, looseness, etc.).

5.4.3 Roughness According to the test in 6.4.3, for soft tissue level dental implants, the implant neck shall be a smooth surface with a roughness Ralpha <= 1.6 µm.

5.5 Cleanliness According to the test in 6.5, the dental implant shall be free from any visible foreign matter.

5.6 Mechanical properties

5.6.1 Torsional resistance According to the test in 6.6.1, under worst-case conditions, the maximum torque between the dental implant and the implant abutment shall meet the following requirements.

a) External connection >= 50 N·cm;

b) Internal connection >= 70 N·cm.

5.6.2 Tightening performance According to the test in 6.6.2, after applying the maximum tightening torque, the dental implant and its components shall not exhibit deformation or breakage upon visual inspection. The maximum loosening torque shall be at least 75% of the maximum tightening torque.

5.6.3 Fatigue limit According to the test in 6.6.3, the fatigue limit of the dental implant shall meet the fatigue performance provisions in the technical documents provided by the manufacturer.

5.7 Sterility According to the test in 6.7, when delivered in a sterile condition, the product shall be sterile.

5.8 Bacterial endotoxins According to the test in 6.8, the endotoxin limit for each dental implant shall not exceed

6.1 Chemical properties

6.1.1 Chemical composition of dental implants without special surface treatment Tests shall be conducted in accordance with the relevant provisions of GB/T 4698 (all parts), using atomic absorption spectrometry, and/or general rules of inductively coupled plasma atomic emission spectrometry, or other precise and sensitive analytical methods.

6.1.2 Chemical composition of dental implant surface The chemical composition of the surface of dental implants with special surface treatment can be analyzed using energy dispersive spectroscopy (EDS) or optical spectroscopy.

6.2 Microstructure Microstructure shall be tested according to

4.6 of GB/T 13810-2017; and grain size shall be tested according to

4.7 of GB/T 13810-2017. One specimen shall be tested, and it shall comply with the provisions of 5.2.

6.3 Dimensions

6.3.1 Measuring instruments. Vernier calipers, micrometers, optical measuring instruments, thread plug gauges and/or thread ring gauges, etc. The measurement accuracy shall meet the requirements of the measurement.

6.3.2 Procedure

6.3.2.1 Geometric dimensions of each part Measure the geometric dimensions of each part of the dental implant using the measuring instruments in 6.3.1. Five dental implants shall be randomly selected from the same batch of finished products of the same model and specification. Each test value shall comply with the provisions of 5.3.1.