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YY 0304-2023 related PDF English

YY 0304-2023 (YY0304-2023) & related versions
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)See DetailStatusSimilar PDF
YY 0304-2023English279 Add to Cart 3 days Plasma sprayed hydroxyapatite coated titanium dental implant YY 0304-2023 Valid YY 0304-2023
YY 0304-2009English110 Add to Cart 0-9 seconds. Auto delivery. Plasma sprayed hydroxyapatite coated-titanium dental implant YY 0304-2009 Valid YY 0304-2009
YY 0304-1998English639 Add to Cart 5 days Plasma sprayed hydroxyapatite coated titanium dental implant YY 0304-1998 Obsolete YY 0304-1998



YY 0304-2023: PDF in English
YY 0304-2023. Plasma sprayed hydroxyapatite coated titanium dental implants
ICS 11.060.10
CCSC33
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY 0304-2009
Plasma sprayed hydroxyapatite coating
Titanium abutment dental implants
Published on 2023-09-05
Implemented on 2026-09-15
Released by the State Drug Administration
Table of contents
Preface III
Introduction IV
1 range 1
2 Normative reference documents 1
3 Terms and Definitions 1
4 Requirements 2
5 Test method 4
Appendix A (informative) Sample preparation method 7
Reference 8
Preface
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents"
Drafting.
This document replaces YY 0304-2009 "Plasma Sprayed Hydroxyapatite Coated Titanium Dental Implants" and is consistent with YY 0304-2009
In addition to structural adjustments and editorial changes, the main technical changes are as follows.
a) "Plasma sprayed hydroxyapatite coating", "Plasma sprayed hydroxyapatite coating-titanium-based dental implant", "Endosseous dental implant" have been changed.
Definitions of "implant" and "crystallinity" (see 3.2, 3.3, 3.4 and 3.6,.2009 edition of 3.2, 3.3, 3.4 and 3.6);
b) The type and structure of dental implants in the requirements are deleted (see 4.1 of the.2009 edition), and the "geometric dimensions of the dental implant body are precisely
"degree" has been adjusted according to the existing technical conditions (see 4.1.1, 4.2.1, 4.2.2 and 4.2.3 of the.2009 version);
c) Change “dimensions and tolerances of important connection parts” to “fitting of dental implants and implant abutments” (see 4.1.4,.2009 edition
4.2.6);
d) Change "HA content and crystallinity in coating" to "crystallinity" (see 4.2.2.1.1, 4.3.2.1.1 of the.2009 version);
e) Added “other crystalline phases” (see 4.2.2.2);
f) The starting value of the range of "calcium to phosphorus atomic ratio" is changed from 1.66 to 1.61 (see 4.2.2.1.3, 4.3.2.1.3 of the.2009 version);
g) Added “Micromorphology of HA coating” (see 4.2.2.3);
h) Added "torsion resistance" and "fastening performance" under "mechanical properties" (see 4.2.5.1, 4.2.5.2);
i) Added “bacterial endotoxin” (see 4.4);
j) The content related to biological evaluation has been deleted, and the expression of biocompatibility has been moved to the introduction (see Introduction, 4.4 of the.2009 version);
k) Relevant content on signs, labels, packaging, transportation, and storage has been deleted (see Chapter 6 of the.2009 edition).
Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents.
This document is proposed by the National Medical Products Administration.
This document is under the jurisdiction of the National Standardization Technical Committee for Dental Materials and Equipment (SAC/TC99).
This document was first published in October.1998, revised for the first time in.2009, and this is the second revision.
introduction
This document does not include qualitative and quantitative test methods used to demonstrate that materials do not present unacceptable biological risks, such as evaluating biological
For risks, please refer to GB/T 16886.1 and YY/T 0268.
Plasma sprayed hydroxyapatite coating
Titanium abutment dental implants
1 Scope
This document specifies the technical requirements and test methods for plasma sprayed hydroxyapatite-coated titanium-based dental implants.
This document is applicable to plasma sprayed hydroxyapatite coated titanium abutment dental implants made of forged titanium or titanium alloy materials as the base material.
Implants.
2 Normative reference documents
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations
For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to
this document.
GB/T 1031-2009 Product Geometric Specification (GPS) Surface roughness parameters and numerical values using surface structure profile method
GB/T 13810-2017 Titanium and titanium alloy processed materials for surgical implants
GB/T 23101.3 Hydroxyapatite for surgical implants Part 3.Chemical analysis and characterization of crystallinity and phase purity
GB/T 23101.4 Hydroxyapatite for surgical implants Part 4.Determination of coating bond strength
YY 0315 Titanium and titanium alloy dental implants
YY/T 0521 Dynamic fatigue test of intraosseous dental implants in dentistry
YY/T 0988.14-2016 Surgical implant coatings Part 14.Stereological evaluation method of porous coatings
ISO /T S13498 Dentistry-Torsion measurement of endosteal dental implant body and connecting parts
Pharmacopoeia of the People's Republic of China 2020 Edition Four Parts
3 Terms and definitions
The following terms and definitions as defined in YY 0315 apply to this document.
3.1
Plasma sprayingplasmaspraying
One type of thermal spraying process uses a non-transfer arc as a heat source to ionize the gas, thereby producing a temperature of up to 10,000°C or more.
The high temperature causes the spray material powder fed into the plasma flame through the spray gun to melt or surface-melt and spray it onto the surface of the substrate at high speed to form a coating.
method.
3.2
Using plasma spraying method to spray hydroxyapatite powder, the hydroxyapatite formed on the surface of metal such as titanium or titanium alloy matrix
(HA) thin layer.
3.3
plant
A medical device surgically implanted into the jaw bone to secure and support dentures. Titanium abutment dental implant base is processed from titanium or titanium alloy
......

BASIC DATA
Standard ID YY 0304-2023 (YY0304-2023)
Description (Translated English) Plasma sprayed hydroxyapatite coated titanium dental implant
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C33
Classification of International Standard 11.060.10
Word Count Estimation 14,193
Date of Issue 2023-09-05
Date of Implementation 2026-09-15
Older Standard (superseded by this standard) YY 0304-2009
Administrative Organization National Standardization Technical Committee for Dental Materials and Equipment (SAC/TC 99)
Proposing organization State Drug Administration
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the technical requirements and test methods for plasma sprayed hydroxyapatite coating-titanium-based dental implants. This standard applies to plasma sprayed hydroxyapatite coating-titanium-based dental implants made of forged titanium or titanium alloy materials as the base material.