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YY 0315-2016 English PDF (YY 0315-2023 Newer Version)

YY 0315-2016_English: PDF (YY0315-2016)
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY 0315-2023English279 Add to Cart 3 days [Need to translate] Wrought titanium and titanium alloy dental implant Valid YY 0315-2023
YY 0315-2016English220 Add to Cart 0--9 seconds. Auto-delivery Wrought titanium and titanium dental implant Valid YY 0315-2016
YY 0315-2008English120 Add to Cart 0--9 seconds. Auto-delivery Wrought titanium and titanium dental implant Obsolete YY 0315-2008
YY 0315-1999English319 Add to Cart 3 days [Need to translate] Pure titanium dental implant Obsolete YY 0315-1999
Preview PDF: YY 0315-2016    Standards related to: YY 0315-2016

BASIC DATA
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Older Standard (superseded by this standard) YY 0315-2008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: ......