YY 0315-2023 (YY0315-2023) & related versions
YY 0315-2023: PDF in English
YY 0315-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S 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 µm.
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 Rα 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:
......
| Standard ID | YY 0315-2023 (YY0315-2023) | | Description (Translated English) | Wrought titanium and titanium alloy dental implant | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C33 | | Classification of International Standard | 11.060.10 | | Word Count Estimation | 14,142 | | Date of Issue | 2023-11-22 | | Date of Implementation | 2026-12-01 | | Older Standard (superseded by this standard) | YY 0315-2016 | | Administrative Organization | National Standardization Technical Committee for Dental Materials and Equipment (SAC/TC 99) | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the performance requirements, packaging, labeling and instructions for use of dental implants without surface coating made of forged titanium and titanium alloy materials, and describes the corresponding test methods. This standard applies to titanium and titanium alloy materials for surgical implants whose chemical composition complies with GB/T 13810 or ISO 5832-2, ISO 5832-3, ISO 5832-11 or ASTM F67, ASTM F136, ASTM F1295, ASTM F1472 Made dental implants. This standard does not apply to dental implant accessories and additively manufactured titanium and titanium alloy dental implants. |
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