YY 0315-2016 (English Version) PDF

Scope: This standard specifies the definition, performance requirements and corresponding test methods of dental implants without surface coating made of titanium and titanium alloy materials, and also stipulates the contents of packaging and labeling. This standard does not cover implant accessories. This standard applies to materials whose chemical composition complies with GB/T 13810-2007 "Titanium and titanium alloy processed materials for surgical implants" or ISO 5832-2, ISO 5832-3, ISO 5832-11 or ASTM F67-00, ASTM F136 -12a. Dental implants made of titanium and titanium alloy materials for surgical implants in ASTM F1295 and ASTM F1472.

YY 0315-2016 Referenced Document

GB/T 13810-2007 Titanium and titanium alloy processing materials for surgical implants
ISO 1942:2009 Dentistry - Vocabulary
ISO 2768-1 General tolerances; part 1: tolerances for linear and angular dimensions without individual tolerance indications
ISO 5832-2 Implants for surgery - Metallic materials - Part 2: Unalloyed titanium*， 2018-03-01 Update
ISO 5832-3 Implants for surgery — Metallic materials — Part 3: Wrought titanium 6-aluminium 4-vanadium alloy*， 2021-11-18 Update
ISO/TS 13498 Dentistry - Torsion test of implant body/connecting part joints of endosseous dental implant systems
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