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YY 0315-2016 English PDF (YY0315-2016)

YY 0315-2016 English PDF (YY0315-2016)

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YY 0315-2016: Wrought titanium and titanium dental implant

This standard specifies the definition, performance requirements, corresponding test methods of dental implants, which are made of titanium and titanium alloys without surface coating; specifies the contents of packaging and marking. Implant accessories are not covered by this standard.
YY 0315-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.060.10
C 33
Replacing YY 0315-2008
Wrought titanium and titanium dental implant
ISSUED ON: JANUARY 26, 2016
IMPLEMENTED ON: JANUARY 01, 2018
Issued by: State Food and Drug Administration
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 6
2 Normative references ... 6
3 Terms and definitions ... 7
4 Materials ... 8
5 Requirements ... 8
6 Test methods ... 11
7 Packaging, marking, instructions for use ... 15
Appendix A (Informative) Electrochemical corrosion ... 17
References ... 18
Wrought titanium and titanium dental implant
1 Scope
This standard specifies the definition, performance requirements,
corresponding test methods of dental implants, which are made of titanium and titanium alloys without surface coating; specifies the contents of packaging and marking. Implant accessories are not covered by this standard.
This standard is applicable to the dental implants, as made from the titanium and titanium alloy materials, whose chemical composition conforms to GB/T 13810-2007 "Wrought titanium and titanium alloy for surgical implants" or ISO 5832-2, ISO 5832-3, ISO 5832-11 or ASTM F67-00, ASTM F136-12a, ASTM
F1295, ASTM F1472, for the purposes of surgical implants.
2 Normative references
The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) is applicable to this standard.
GB 4698 (all parts) Methods for chemical analysis of titanium sponge,
titanium and titanium alloys
GB/T 13810-2007 Wrought titanium and titanium alloy for surgical implants YY/T 0268 Dentistry - Biological evaluation of medical devices used in
dentistry - Part 1: Evaluation and test
YY/T 0343-2002 Liquid penetrant inspection of metallic surgical implants YY/T 0521-2009 Dentistry implants - Dynamic fatigue test for endosseous dental implants
Pharmacopoeia of the People's Republic of China (Part II)
ISO 1942:2009 Dentistry - Vocabulary
ISO 2768-1 General tolerances - Part 1: Tolerances for linear and angular dimensions without individual tolerance indications
alloy materials for surgical implants, including the relevant provisions of ISO 5832-2, ISO 5832-3, ISO 5832-11 or ASTM F67-00, ASTM F136-12a, ASTM
F1295, ASTM F1472 on the chemical compositions of titanium and titanium alloy materials for surgical implants.
5.1.2 For dental implants whose surface is specially treated, when the chemical composition of the surface is tested in accordance with 6.1.2, it shall conform to the detailed information, which is provided by the manufacturer. The chemical composition of dental implants shall, according to 6.1.1 test, comply with Article 3.3 in GB/T 13810-2007, OR the relevant provisions of ISO 5832-2, ISO 5832- 3, ISO 5832-11, OR ASTM F67-00, ASTM F136-12a, ASTM F1295, ASTM
F1472 on the chemical composition of titanium and titanium alloy materials for surgical implants.
5.2 Microstructure
According to the test in 6.2, the microstructure of the dental implant shall comply with the relevant provisions in 3.6.2 of GB/T 13810-2007.
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 dental implants are ?? 0.2 mm; the angle tolerances shall meet the requirements for the precision tolerance grade of angles in ISO 2768-1.
5.3.2 The fitting of dental implants and implant abutments
5.3.2.1 Fitting of the connection taper in dental implants
For dental implants with internal connection taper, according to the test in 6.3.2.2.1, the internal connection interface between the dental implant and the implant abutment shall be well matched, meanwhile the taper deviation shall not be greater than ??3% of the taper value, which is provided by the
manufacturer.
5.3.2.2 Fitting gap between dental implant and implant abutment
According to the test in 6.3.2.2.2, the matching gap between the dental implant and the implant abutment shall be ??? 0.035 mm.
5.3.2.3 Thread deviation
For the abutment-detachable dental implant, the thread code and the thread tolerance band code shall be given for the connecting thread.
When tested in accordance with 6.3.2.2.3, the thread deviation shall comply with the manufacturer's specifications.
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 scratches, cracks, sharp edges, burrs, screw edges, or other macro defects as caused by processing; meanwhile, there is no foreign attachment. 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 porosity, inclusions, looseness, etc.). 5.4.3 Roughness
According to the test in 6.4.3, the roughness of the dental implant neck: Ra ??? 1.6 ??m.
5.5 Cleaning
According to the test in 6.5, the dental implant shall have no visible attachments. 5.6 Mechanical properties
The mechanical properties of dental implants, implant abutments, central screws, after assembly, shall comply with the provisions of 5.6.1 ~ 5.6.3. 5.6.1 Torsion resistance
In accordance with the test in 6.6.1, under the worst case, the maximum torque for dental implants and implant abutments shall comply with the following requirements:
a) External connection ??? 50 Ncm;
b) Internal connection ??? 70 Ncm.
5.6.2 Tightening torque
According to the test in 6.6.2, after applying the maximum tightening torque, observe the dental implant and supporting parts with the naked eye; no
deformation or breakage shall occur. The maximum loosening torque shall be more than 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 comply 6.3.2.1 Geometric dimensions of each part
Measure the geometric dimensions of each part of the dental implant, by the instrument of 6.3.1.
Measure 5 dental implants which have the same model. All 5 measurement
results shall meet the requirements of 5.3.1.
6.3.2.2 The cooperation of dental implants and implant abutments
6.3.2.2.1 Fitting of the connection taper in dental implants
Use the implant abutment, which is provided by the manufacturer, to cooperate with the dental implant. Screw the dental implant; the internal connection interface, between the dental implant and the implant abutment, shall cooperate well. The taper of the internal connection can be measured directly, by a taper plug gauge/ring gauge, or the taper of the implant abutment can be measured, by an optical measuring instrument.
Use an optical measuring instrument to measure the taper of the implant abutment; the deviation is not greater than ??3% of the marked value, which is provided by the manufacturer.
Measure 5 dental implants and matching implant abutments of the same model; the 5 measurement results shall meet the requirements of 5.3.2.1.
6.3.2.2.2 Fitting gap between dental implant and implant abutment
Assemble the dental implant and its matching implant abutment together. Use central screws to fix it. Then use dental self-setting resin to embed it. After the self-setting resin is completely cured, cut it in half, along the long axis of the dental implant. Grind and polish half of the cut surfaces. Use an optical measuring instrument, to measure the fitting gap between the dental implant and the implant abutment (including the end face gap and the cone face gap, that is, the maximum vertical distance from the end point to the opposite side, as shown in Figure 1).
For dental implants, which have internal connection taper, the dental implant and implant abutment, after completing the steps of 6.3.2.2.1, can be fixed by retaining screws, THEN each fitting gap can be tested.
Measure 5 dental implants and matching implant abutments of the same model; the 5 measurement results shall meet the requirements of 5.3.2.2.
6.4.3 Roughness
Use the comparison or needle tracing method, to measure the neck of the dental implant.
The comparison method uses roughness comparison samples, with the aid of a magnifying glass of 5X ~ 10X, for comparison and inspection.
The needle tracing method uses an electric profilometer, to directly measure the R?? value of the measured surface.
Measure 5 dental implants of the same model. The 5 measurement results shall meet the requirements of 5.4.3.
Note: The roughness is based on the needle tracing method as the arbitration method. 6.5 Cleaning
Put 30 mL of acetone or ethanol in a 50 mL beaker. Take 5 dental implants. Put them in the beaker. After ultrasonic cleaning for 10 minutes, use tweezers to take out all the dental implants from the beaker. Use qualitative filter paper to filter the liquid in the beaker. There shall be no visible substance.
6.6 Mechanical properties
6.6.1 Torsion resistance
Carry out test in accordance with ISO/TS 13498; it shall comply with the provisions of 5.6.1.
6.6.2 Tightening torque
Fix the dental implant on the torque tester. The measurement accuracy of the torque tester is at least 0.01 Nm. Assemble the implant abutment, according to the manufacturer's instructions. Use a wrench, to tighten the central screw or implant abutment, until the torque tester reaches 120% of the value, which is specified in the manufacturer's technical documents. Maintain the load for 5 s. Visually observe the dental implant and its supporting parts, which shall not be deformed or broken.
Use a wrench, to loosen the central screw or implant abutment, in the opposite direction. Read the maximum torque, during the loosening process, on the torque meter.
Measure 3 dental implants of the same model; the 3 measurement results shall meet the requirements of 5.6.2.
6.6.3 Fatigue limit
Carry out test, according to YY/T 0521-2009, it shall meet the requirements of 5.6.3.
6.7 Sterility
Carry out test, according to the "sterility inspection method" in "Pharmacopoeia of the People's Republic of China (Part II)", it shall meet the requirements of 5.7.
6.8 Bacterial endotoxins
Carry out test, according to the "bacterial endotoxin inspection method" in "Pharmacopoeia of the People's Republic of China (Part II)", it shall meet the requirements of 5.8.
7 Packaging, marking, instructions for use
7.1 Product marking
If the size and surface conditions of the dental implant permit, on the premise of not affecting the performance of the dental implant, a clear manufacturer's mark, product batch (serial) number, specification mark shall be made, on the appropriate area of the surface of each dental implant. If size and surface conditions do not allow, labels or other methods shall be used, to provide the required information, to ensure traceability.
7.2 Labeling and package marking
The labels and package markings of dental implants shall include at least the following:
a) Product name, model, specification;
b) The name, address, contact information of the manufacturer;
c) The production date or batch (serial) number;
d) Sterilized products shall be marked with the expiration date of sterilization; e) Graphics, symbols, other related content, that shall be marked according to product characteristics.
7.3 Instructions for use
The instructions for use, which is enclosed in the external packaging of dental implants, shall contain at least the following contents:

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