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Preview PDF: YY 0315-2016 Standards related to: YY 0315-2016
Standard ID | YY 0315-2016 (YY0315-2016) | Description (Translated English) | Wrought titanium and titanium dental implant | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | Classification of Chinese Standard | C33 | Classification of International Standard | 11.060.10 | Word Count Estimation | 12,139 | Date of Issue | 1/26/2016 | Date of Implementation | 2018-01-01 | Older Standard (superseded by this standard) | YY 0315-2008 | Quoted Standard | GB 4698.1; GB 4698.2; GB 4698.3; GB 4698.4; GB 4698.5; GB 4698.6; GB 4698.7; GB 4698.8; GB 4698.9; GB 4698.10; GB 4698.11; GB 4698.12; GB 4698.13; GB 4698.14; GB 4698.15; GB 4698.17; GB 4698.18; GB 4698.19; GB 4698.20; GB 4698.21; GB 4698.22; GB 4698.23; GB 4698.24; GB/T 13810- | Drafting Organization | The State Food and Drug Administration Beijing Medical Device Quality Supervision and Inspection Center, West China Medical University, Ministry of Health Oral Technology Center, Beijing Leiden Biological Materials Co., Ltd. | Administrative Organization | National Standardization Technical Committee for Dental Materials and Devices (SAC/TC 99) | Regulation (derived from) | China Food and Drug Administration Bulletin 2016 No.25 | Proposing organization | State Food and Drug Administration | Issuing agency(ies) | State Food and Drug Administration | Summary | This standard specifies the definition, performance requirements and corresponding test methods for dental implants made of titanium and titanium alloy without surface coating, and specifies the contents of packaging and labeling. This standard does not contain implant attachments. This standard applies to the chemical composition in accordance with GB/T 13810-2007 "artificial plant titanium and titanium alloy processing materials" or ISO 5832-2, ISO 5832-3, ISO 5832-11 or ASTM F67-00, ASTM F136- 12a, ASTM F1295, ASTM F1472 in the implantation of titanium and titanium alloy dental implant materials. |
YY 0315-2023.Titanium and titanium alloy dental implants
ICS 11.060.10
CCSC33
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY 0315-2016
Titanium and titanium alloy dental implants
Released on 2023-11-22
2026-12-01 implementation
The State Drug Administration issued
Preface
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
This document replaces YY 0315-2016 Titanium and Titanium Alloy Dental Implants. Compared with YY 0315-2016, except for structural adjustments and editing
In addition to the changes in performance, the main technical changes are as follows.
--- Changed the scope (see Chapter 1, Chapter 1 of the.2016 edition);
--- Changed the "microstructure" requirements and test methods (see 5.2 and 6.2, 5.2 and 6.2 of the.2016 edition);
--- Changed the "roughness" requirement (see 5.4.3, 5.4.3 of the.2016 edition);
--- Changed the "size" requirements and test methods (see 5.3 and 6.3, 5.3 and 6.3 of the.2016 edition);
--- Change the title "Tightening torque" to "Tightening performance" (see 5.6.2, 5.6.2 of the.2016 edition);
--- Changed the requirements for "bacterial endotoxins" (see 5.8, 5.8 of the.2016 edition);
--- Added judgment rules to the test method (see Chapter 6, Chapter 6 of the.2016 edition);
--- Changed the "Appearance" test method (see 6.4.1, 6.4.1 of the.2016 edition).
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the National Technical Committee for Standardization of Dental Materials and Instruments (SAC/TC99).
The previous versions of this document and the documents it replaces are as follows.
---First issued in.1999 as YY 0315-1999, first revised in.2008, and second revised in.2016;
---This is the third revision.
introduction
At present, there is no surgical implant material that is completely non-toxic to the human body. However, long-term clinical application shows that this document
The chemical composition involved in the test complies with GB/T 13810 or ISO 5832-2, ISO 5832-3, ISO 5832-11 or ASTM F67,
Titanium and titanium alloy materials required for surgical implants in ASTM F136, ASTM F1295, and ASTM F1472
(excluding surface treatment materials), if used within the applicable scope, its expected biological response is acceptable.
This document does not include quantitative requirements for the electrochemical corrosion resistance of dental implants. However, if the surface modification of dental implants affects their corrosion resistance
If the dental implant and the implant abutment are made of incompatible metal materials that may undergo electrochemical reactions, electrochemical corrosion must be considered.
Appendix A gives two commonly used electrochemical corrosion test methods.
This document does not contain qualitative and quantitative requirements for possible biological hazards, but it is recommended to refer to
GB/T 16886.1 and YY/T 0268.
Titanium and titanium alloy dental implants
1 Scope
This document specifies the performance requirements, packaging, labeling and use of dental implants made of wrought titanium and titanium alloy materials without surface coating.
Instructions for use and description of the corresponding test methods.
This document is applicable to products with chemical composition in accordance with GB/T 13810 or ISO 5832-2, ISO 5832-3, ISO 5832-11 or ASTMF67,
Dental implants made of titanium and titanium alloy materials for surgical implants in ASTMF136, ASTMF1295, and ASTMF1472.
This document does not apply to dental implant accessories and additively manufactured titanium and titanium alloy dental implants.
2 Normative references
The contents of the following documents constitute the essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB/T 1804 General tolerances Tolerances of linear and angular dimensions without tolerance indication
GB/T 4698 (all parts) Chemical analysis methods for titanium sponge, titanium and titanium alloys
GB/T 9937 Dental terminology
GB/T 13810-2017 Titanium and titanium alloy processed materials for surgical implants
YY/T 0343 Liquid Penetrant Testing of Surgical Metal Implants
YY/T 0521 Dentistry Implants - Dynamic fatigue test of endosseous dental implants
YY/T 1619 Terminology of dental implant systems and related processes
Pharmacopoeia of the People's Republic of China (2020 Edition)
ISO 5832-2 Implants for surgery - Metallic materials - Part 2.Pure titanium
Materials-Part 2.Unaloyed titanium)
ISO 5832-3 Metallic materials for surgical implants Part 3.Ti-6Al-4V wrought alloy (Implantsforsurgery-
ISO 5832-11 Metallic materials for surgery Part 11.Ti-6Al-7Nb wrought alloy (Implantsforsurgery-
ISO /T S13498 Dentistry - Torsion test of implants and connecting components of endosseous dental implant systems
3 Terms and definitions
The terms and definitions defined in GB/T 9937 and YY/T 1619 and the following apply to this document.
3.1
implant neck implantneck
The part of a dental implant that penetrates the gums.
Note. Applicable to soft tissue level dental implants.
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:
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