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YY/T 0521-2018: Dentistry--Implants--Dynamic fatigue test for endosseous dental implants
Status: Valid YY/T 0521: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0521-2018 | English | 279 |
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Dentistry--Implants--Dynamic fatigue test for endosseous dental implants
| Valid |
YY/T 0521-2018
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| YY/T 0521-2009 | English | 399 |
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Dentistry. Implants. Dynamic fatigue test for endosseous dental implants
| Obsolete |
YY/T 0521-2009
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PDF similar to YY/T 0521-2018
Standard similar to YY/T 0521-2018 YY/T 0519 YY 0315 YY/T 0520 YY/T 0514 Basic data | Standard ID | YY/T 0521-2018 (YY/T0521-2018) | | Description (Translated English) | Dentistry--Implants--Dynamic fatigue test for endosseous dental implants | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C33 | | Word Count Estimation | 14,123 | | Date of Issue | 2018-04-11 | | Date of Implementation | 2019-05-01 | | Older Standard (superseded by this standard) | YY/T 0521-2009 | | Regulation (derived from) | China Drug Administration Announcement No. 4 of 2018 | | Issuing agency(ies) | State Drug Administration | YY/T 0521-2018: Dentistry--Implants--Dynamic fatigue test for endosseous dental implants---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.
(Dentistry Implants Bone Injury Dynamic Fatigue Test)
ICS 11.060.10
C33
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0521-2009
Dental implant endodontic implant
Dynamic fatigue test
Published on.2018-04-11
2019-05-01 implementation
State Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 0521-2009 "Dental fatigue test of dental implants in dentistry". With YY/T 0521-2009
In addition to the editorial changes, the main technical changes are as follows.
--- Added 3.3 bone implant implant components;
--- Added 4.2 requirements "In the method recommended by the manufacturer, the tightening torque should be noted";
--- Added 4.2 requirements "If the manufacturer does not indicate the tightening torque in the manual, the appropriate tightening torque should be determined before the test";
--- In 5.3.1, change "the modulus of elasticity should be greater than 3GPa" to "the modulus of elasticity (compression modulus of elasticity) should be greater than 3GPa";
--- In 5.3.1, the "intra-bone fixation of the specimen should be fixed with a rigid fixture" should be changed to "the internal fixation of the specimen should be used
Rigid fixture fixing (it is recommended to embed the specimen in the embedding material and then use the rigid fixture to fix it)";
--- Change the "test can be carried out in air at 20 °C ± 5 °C" in 5.4 to "For other planting systems, the test can be
Conducted in air at a temperature of 20 ° C ± 10 ° C";
--- Cancel the "determination of the critical failure point and locate the location of the damage origination" in 5.6.3 to "describe the failure mode of the affected part, such as
If possible, describe the failure process (eg, screw fracture and subsequent abutment fracture);
--- Increase 5.7 "Alternative method --- ladder method";
--- Added Appendix B "Worst Case Determination Guide".
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Technical Committee for Standardization of Dental Materials and Devices (SAC/TC99).
This standard was drafted. National Drug Administration, Peking University Medical Device Quality Supervision and Inspection Center, Beijing Leiden Biomaterials Co., Ltd.
the company.
The main drafters of this standard. Zheng Gang, Yuan Shenpo, Bai Wei, Li Yuan, Lin Hong, Sun Zhihui.
The previous versions of the standards replaced by this standard are.
---YY/T 0521-2009.
Dental implant endodontic implant
Dynamic fatigue test
1 Scope
This standard specifies the fatigue test method for wearing a mucosal single-bone internal dental implant and its pre-repair assembly. This method is different in comparison
It is especially useful when designing different sizes of intraosseous implants.
Although this standard simulates the functional load of the main body of the endodontic implant and the pre-repaired component under "worst case" conditions, it is not applicable.
To predict the in vivo performance of endodontic implants or restorations, especially for multi-pile implant restorations.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 3075-2008 Metallic materials fatigue test axial force control method (ISO 1099.2006, MOD)
GB/T 9937-2008 Oral vocabulary (all) (ISO 1942. 1989, IDT)
GB/T 16825.1-2008 Inspection of static single-axis testing machines - Part 1 . Examination of tensile force and/or pressure testing machine
Inspection and calibration (ISO 7500-1.2004, IDT)
ISO 4965-1.2012 Dynamic force calibration for uniaxial fatigue testing of metallic materials - Part 1
Metallic materials - Axial load fatigue testing machines - Dynamic force calibration - Part 2. Dynamic calibration equipment (DCD)
Test instrument
3 Terms and definitions
The following terms and definitions as defined in GB/T 9937-2008 apply to this document.
3.1
Endosenous dental implant system endosseousdentalimplantsystem
A device consisting of multiple components, including implant preparation and placement of implants in the clinical and laboratory, and corresponding restorations
Auxiliary tools and special equipment necessary for seating and seating.
Note 1. In addition to resisting the displacement of the dental restoration, the endodontic implant can also be used as an orthodontic anchorage.
Note 2. The endodontic implant can be composed of one or more parts.
Note 3. The concept of dental restorations includes crowns and fixed prostheses, active restorations.
3.2
Load cycle diagram load-cyclediagram
A curve showing the fatigue performance of the implants in the bone by showing the number of cycles that each sample is subjected to under each peak load.
Figure (see Appendix A).
3.3
Endosenous dental implant assembly endosseousdentalimplantassembly
The individual components of the implant are assembled together according to the manufacturer's instructions.
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