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YY/T 0521-2018Dentistry—Implants—Dynamic fatigue test for endosseous dental implants (English PDF)

牙科学 种植体 骨内牙种植体动态疲劳试验

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

April 11, 2018

Implementation date

May 1, 2019

Scope

YY/T 0521-2018 is the English-translated version of 牙科学 种植体 骨内牙种植体动态疲劳试验.

YY/T 0521-2018 is the Chinese pharmaceutical industry standard that gives the dynamic fatigue test for endosseous dental implants and their premanufactured prosthetic components.

The implant is loaded in a way that reproduces the worst case of function in the mouth, and the standard fixes the specimen, the embedding, the angle and point of load application, the frequency and the number of cycles and the way the result is reported, which makes it useful above all for comparing designs and sizes. Issued on 11 April 2018, it has applied since 1 May 2019.

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Document preview — YY/T 0521-2018

National Standard of the People's Republic of China

Classification
C 33
Replacing
YY/T 0521-2009

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • Foreword
  • 1 Scope
  • 2 Normative references
  • 3 Terms and definitions

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".

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 document. 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

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

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

The individual components of the implant are assembled together according to the manufacturer's instructions.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.

Referenced standards

Similar standards

Editions of YY/T 0521

EditionTitleRevisionStatus
YY/T 0521-2018Dentistry—Implants—Dynamic fatigue test for endosseous dental implantscurrent editionCurrent
YY/T 0521-2009Dentistry—Implants—Dynamic fatigue test for endosseous dental implantsprevious editionSuperseded

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