YY 0304-2023Plasma sprayed hydroxyapatite coated titanium dental implant (English PDF)
等离子喷涂羟基磷灰石涂层 钛基牙种植体
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
September 5, 2023
Implementation date
September 15, 2026
Scope
YY 0304-2023 is the English-translated version of 等离子喷涂羟基磷灰石涂层 钛基牙种植体.
YY 0304 is the mandatory Chinese standard for titanium dental implants carrying a plasma-sprayed hydroxyapatite coating. The coating exists to speed osseointegration by presenting a bone-like mineral surface, and its risk is the mirror image of its benefit: a coating that delaminates or resorbs unevenly leaves a compromised implant in place of an intact one. This document sets the requirements such an implant has to meet and the test methods that verify them, covering the composition and crystallinity of the coating, its thickness, its adhesion to the titanium substrate, and the properties of the implant beneath it. Being a YY standard without the /T suffix, compliance is compulsory in China. The 2023 edition takes effect in September 2026, which is the date a manufacturer has to work back from.
Document preview — YY 0304-2023
National Standard of the People's Republic of China
Issued by: National Medical Products Administration
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- About this edition
- Classification and status
- How a Chinese national standard is set out
- About this English translation
Foreword
This document was issued on 5 September 2023 by the National Medical Products Administration and takes effect on 15 September 2026.
It is a YY standard without the /T suffix: compliance is mandatory in China.
1 Scope
YY 0304 is the mandatory Chinese standard for titanium dental implants carrying a plasma-sprayed hydroxyapatite coating. The coating exists to speed osseointegration by presenting a bone-like mineral surface, and its risk is the mirror image of its benefit: a coating that delaminates or resorbs unevenly leaves a compromised implant in place of an intact one. This document sets the requirements such an implant has to meet and the test methods that verify them, covering the composition and crystallinity of the coating, its thickness, its adhesion to the titanium substrate, and the properties of the implant beneath it. Being a YY standard without the /T suffix, compliance is compulsory in China. The 2023 edition takes effect in September 2026, which is the date a manufacturer has to work back from.
Remaining clauses in the full document
- 2 Normative references
- 3 Terms and definitions
- About this edition
- Classification and status
- How a Chinese national standard is set out
- About this English translation
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
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YY 0304-2023
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