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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.

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Document preview — YY 0304-2023

National Standard of the People's Republic of China

Issued by: National Medical Products Administration

Foreword
1 Scope
2 Normative references
3 Terms and definitions

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

......
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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