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YY 0315-2023: Wrought titanium and titanium alloy dental implant
Status: Valid YY 0315: Evolution and historical versions
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| YY 0315-2023 | English | 279 |
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Wrought titanium and titanium alloy dental implant
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| YY 0315-2016 | English | 220 |
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Wrought titanium and titanium dental implant
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| YY 0315-2008 | English | 120 |
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Wrought titanium and titanium dental implant
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| YY 0315-1999 | English | 319 |
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Pure titanium dental implant
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PDF similar to YY 0315-2023
Standard similar to YY 0315-2023 YY 0270.1 YY 0304 YY 0271.2 YY 0272 Basic data | 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Count Estimation | 14,131 | | Date of Issue | 2023-11-22 | | Date of Implementation | 2026-12-01 | | Older Standard (superseded by this standard) | YY 0315-2016 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the performance requirements,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. | YY 0315-2023: Wrought titanium and titanium alloy dental implant---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
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
Foreword
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.
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