Scope:

This standard defines dental implants made of titanium and titanium alloy materials without surface coating Performance requirements and corresponding testing methods have been established, and the contents of packaging and labeling have been specified. This standard does not include implant attachments.

This standard is applicable to dental implants made of titanium and titanium alloy materials for surgical implants that meet the chemical composition requirements of GB/T 13810-2007 "Titanium and Titanium Alloy Processing Materials for Surgical Implants" or ISO 5832-2, ISO 5832-3, ISO 5832-11, or ASTM F67-00, ASTM F136-12a, ASTM F1295, ASTM F1472.

Testing instruments:

PBSC-BP30 bone screw performance tester

Test method:

Fix the dental implant on the torque tester with a measurement accuracy of at least 0.01 Nm. Assemble the implant base according to the manufacturer's instructions, tighten the central screw or implant base with a wrench until the torque tester reaches 120% of the specified value in the manufacturer's technical documents, maintain the load for 5 seconds, and visually observe the dental implant and supporting components without deformation or fracture.

Use a wrench to loosen the central screw or implant base in the opposite direction, and read the maximum torque during the loosening process on the torque tester. Three dental implants of the same model should be measured, and the results of the three measurements should meet the agreement. After applying the maximum tightening torque, the dental implants and supporting components should be visually observed without deformation or fracture.

The regulations.

Technical Specifications:

Design standards:

YY 0018-2016 [Metal bone screw for bone graft implants]

YY/T 1504 [Test Method for Axial Pulling Force of Metal Bone Screws]

YY/T 1505 [Test Method for Self tapping Performance of Metal Bone Screws]

YY/T 1506 [Test Method for Torque of Metal Bone Screws]

YY/T 0346 [Metal femoral neck fixation nail with bone graft implant]

YY 0315-2016 [Titanium and Titanium Alloy Dental Implants]

YYT 0119.2-2014 [Spinal Implants - Components of Spinal Internal Fixation Systems - Part 2: Metal Spinal Screws]

ASTM F543 【Standard Specification and Test Methods forMetallic Medical Bone Screws】