This standard specifies the technical requirements, test methods, product classification, marking, labeling, packaging, transportation and storage requirements for plasma sprayed hydroxyapatite coating-titanium-based dental implants. This standard applies to plasma-sprayed hydroxyapatite-coated titanium-based endoosseous dental implants implanted in the jaw after tooth loss.
YY 0304-2009 Referenced Document
GB/T 13810-2007 Titanium and titanium alloy processing materials for surgical implants
GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*, 2022-04-15 Update
ISO 14801:2007 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants
YY/T 0268 Dentistry.Biological evaluation of medical devices used in dentistry.Part 1:Evaluation and test
YY/T 0313-1998 Package,lable,transport and storage for medical polymer products