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YY 0315-2023: Wrought titanium and titanium alloy dental implant
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YY0315-2023
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.060.10
CCS C 33
Replacing YY 0315-2016
Wrought Titanium and Titanium Alloy Dental Implant
Issued on: NOVEMBER 22, 2023
Implemented on: DECEMBER 1, 2026
Issued by. National Medical Products Administration
Table of Contents
Foreword... 3
Introduction... 4
1 Scope... 5
2 Normative References... 5
3 Terms and Definitions... 6
4 Materials... 6
5 Requirements... 6
6 Test Methods and Judgment Rules... 9
7 Packaging, Marking, and Instructions for Use... 13
Appendix A (Informative) Electrochemical Corrosion... 15
Bibliography... 16
Wrought Titanium and Titanium Alloy Dental Implant
1 Scope
This Document specifies the performance requirements, packaging, labeling, and instructions
for use of uncoated dental implants made of wrought titanium and titanium alloys; and describes
the corresponding test methods.
This Document applies to dental implants made of titanium and titanium alloys with chemical
compositions conforming to GB/T 13810, ISO 5832-2, ISO 5832-3, ISO 5832-11, or ASTM
F67, ASTM F136, ASTM F1295, and ASTM F1472 for surgical implants.
This Document does not apply to dental implant accessories and additively manufactured
titanium and titanium alloy dental implants.
2 Normative References
The provisions in following documents become the essential provisions of this Document
through reference in 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 Document.
GB/T 1804 General tolerances - Tolerances for linear and angular dimensions without
individual tolerance indications
GB/T 4698 (all parts) Methods for chemical analysis of titanium sponge, titanium and
titanium alloys
GB/T 9937 Dentistry - Vocabulary
GB/T 13810-2017 Wrought titanium and titanium alloy for surgical implants
YY/T 0343 Liquid penetrant inspection of metallic surgical implants
YY/T 0521 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants
YY/T 1619 Dentistry - Vocabulary for dental implants systems and related procedure
Pharmacopoeia of the People's Republic of China (2020 Edition)
ISO 5832-2 Implants for surgery - Metallic materials - Part 2.Unalloyed titanium
ISO 5832-3 Implants for surgery - Metallic materials - Part 3.Wrought titanium 6-
aluminium 4-vanadium alloy
ISO 5832-11 Implants for surgery - Metallic materials - Part 11.Wrought titanium-6-
aluminium 7-niobium alloy
ISO/TS 13498 Dentistry - Torsion test of implant body/connecting part joints of
endosseous dental implant systems
3 Terms and Definitions
For the purposes of this Document, the terms and definitions given in GB/T 9937 and YY/T
1619 and the following apply.
3.1 Implant neck
The portion of the dental implant that crosses the gum line.
NOTE. Applicable to dental implants at the soft tissue level.
4 Materials
The technical indicators of materials used in the fabrication 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, ASTM F67, ASTM F136, ASTM F1295, and ASTM F1472 concerning
titanium and titanium alloy materials for surgical implants.
5 Requirements
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 3.3.2.5 or 3.3.3.5 in GB/T 13810-2017.The grain size shall comply with the
relevant provisions of 3.3.2.6 or 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 Rα ≤ 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 20.0
EU.
6 Test Methods and Judgment Rules
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.
6.3.2.2 Fit between dental implant and implant abutment
6.3.2.2.1 Fit at the connection point of dental implant
Assemble the dental implant and implant abutment according to the manufacturer's instructions.
Tighten the abutment screws or implant abutment with a wrench until the tightening torque is
reached. The implant abutment shall not fall off or rotate.
Five dental implants and matching implant abutments shall be randomly selected from the same
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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