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GB 23101.2-2025 English PDF

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GB 23101.2-2025: Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite
Status: Valid

GB 23101.2: Evolution and historical versions

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GB 23101.2-2025English359 Add to Cart 4 days [Need to translate] Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite Valid GB 23101.2-2025
GB 23101.2-2008English90 Add to Cart 0--9 seconds. Auto-delivery Implants for surgery -- Hydroxyapatite -- Part 2: Coatings of hydroxyapatite Valid GB 23101.2-2008

Standard similar to GB 23101.2-2025

GB/T 23101.4   GB/T 23101.3   GB/T 23101.6   

Basic data

Standard ID GB 23101.2-2025 (GB23101.2-2025)
Description (Translated English) Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite
Sector / Industry National Standard
Classification of Chinese Standard C35
Classification of International Standard 11.040.40
Word Count Estimation 18,133
Date of Issue 2025-08-01
Date of Implementation 2028-08-01
Older Standard (superseded by this standard) GB 23101.2-2008
Issuing agency(ies) State Administration for Market Regulation, Standardization Administration of China

GB 23101.2-2025: Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite


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ICS 11.040.40 CCSC35 National Standard of the People's Republic of China Replaces GB 23101.2-2008 Hydroxyapatite for surgical implants Part 2.Hydroxyapatite thermal spray coatings (ISO 13779-2.2018,MOD) Released on August 1, 2025 Implementation on August 1, 2028 State Administration for Market Regulation The National Standardization Administration issued

Table of Contents

Preface III Introduction V 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Coating Preparation 2 5.Requirement 2 6 Test Report 4 Appendix A (Informative) Other possible characterization tests 5 Appendix B (Informative) Comparison of Impurity Crystalline Phase Content Limits 6 References 8 Preface This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents" Drafting. This document is Part 2 of GB (GB/T) 23101 Hydroxyapatite for surgical implants. GB (GB/T) 23101 has been published. The following sections. --- Part 1.Hydroxyapatite ceramics; --- Part 2.Hydroxyapatite thermal spray coatings; --- Part 3.Chemical analysis and characterization of crystallinity and phase purity; --- Part 4.Determination of coating adhesion strength; --- Part 6.Powders. This document replaces GB 23101.2-2008 "Hydroxyapatite for surgical implants Part 2.Hydroxyapatite coatings" and Compared with GB 23101.2-2008, in addition to structural adjustments and editorial changes, the main technical changes are as follows. --- Changed the scope of the content (see Chapter 1, Chapter 1 of the.2008 edition); --- Added the term and definition of "hydroxyapatite thermal spray coating" (see 3.1), deleted "hydroxyapatite ceramics" and "hydroxyapatite Terms and definitions of "stone" and "coating" (see Chapter 3 of the.2008 edition); --- Added coating preparation requirements (see Chapter 4); --- Changed the requirements for calcium-phosphorus atomic ratio (see 5.2, 4.1 of the.2008 edition); --- Changed the requirements for trace elements (see 5.3, 4.2 of the.2008 edition); --- Changed the requirements for impurity crystalline phase content (see 5.4, 4.3 of the.2008 edition); --- Increased crystallinity requirements (see 5.5); --- Added morphological requirements (see 5.6); --- Changed the requirements for coating/substrate interface bonding strength (see 5.7, 4.4 of the.2008 edition); --- Increased test method precision (see 5.8); --- Added test report requirements (see Chapter 6). This document is modified to adopt ISO 13779-2.2018 “Hydroxyapatite for surgical implants – Part 2.Hydroxyapatite thermal spray coatings” layer". The technical differences between this document and ISO 13779-2.2018 and their reasons are as follows. --- The normative reference GB/T 23101.6 replaces ISO 13779-6 (see Chapter 4) to adapt to my country's technical conditions and provide High operability; --- The normative reference GB/T 23101.3 replaces ISO 13779-3 (see Chapter 3, 5.2~5.5, 5.8) to adapt to my country's Technical conditions to improve operability; --- The normative reference GB/T 16886.1 replaces ISO 10993-1 (see 5.3) to adapt to my country's technical conditions and improve the reliability of the product. operability; --- The normative reference GB/T 10610 replaces ISO 4288 (see 5.6) to adapt to my country's technical conditions and improve operability. Sexuality; --- The normative reference GB/T 23101.4 replaces ISO 13779-4 (see 5.7) to adapt to my country's technical conditions and improve availability. operability; --- The normative reference YY/T 0988.12 replaces ASTM F1044 (see 5.7) to adapt to my country's technical conditions and improve operability; --- The normative reference YY/T 0988.14 replaces ASTM F1854 (see 5.5 to 5.7) to adapt to my country's technical requirements. parts, improve operability; --- Changed the requirements for static shear bond strength test samples to specify 10 valid results to improve accuracy (see 5.7). The following editorial changes have been made to this document. --- The informative reference YY/T 0988.13 replaces ASTM F1160 (see 5.7, A.4) to adapt to my country's technical requirements parts, improve operability; --- The informative reference YY/T 1640 replaces ASTM F 1926 (see A.2) to adapt to my country's technical conditions and improve availability. Operability. Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed and coordinated by the State Food and Drug Administration. The previous versions of this document and the documents it replaces are as follows. ---First issued in.2008 as GB 23101.2-2008; ---This is the first revision.

introduction

Hydroxyapatite is a bone repair material and is widely used in surgical implants. The series of standards on hydroxyapatite provide the performance requirements of hydroxyapatite ceramics, hydroxyapatite thermal spray coatings and hydroxyapatite powder. GB (GB/T) 23101 is intended to consist of five parts. --- Part 1.Hydroxyapatite ceramics. Aims to specify the requirements for hydroxyapatite ceramics used as surgical implants. --- Part 2.Hydroxyapatite thermal spray coatings. Aims to specify single-layer thermal sprayed hydroxyapatite for metallic surgical implants Coating requirements. --- Part 3.Chemical analysis and characterization of crystallinity and phase purity. Aims to provide hydroxyapatite materials, including powders, coatings or Determination of chemical analysis, crystallinity and phase composition evaluation of ceramics. --- Part 4.Determination of adhesion strength of coatings. Aims to provide a method for measuring the adhesion strength of hydroxyapatite coatings. --- Part 6.Powder. Aims to specify the requirements for hydroxyapatite powder raw materials. Currently, none of the known surgical implant materials has been proven to be completely non-toxic to the human body. The materials involved have been shown in long-term clinical applications to produce acceptable levels of expected biological responses if the materials are used appropriately. The biological response of hydroxyapatite coatings has been confirmed by historical clinical use and laboratory studies. Hydroxyapatite for surgical implants Part 2.Hydroxyapatite thermal spray coatings

1 Scope

This document specifies the requirements for single-layer thermally sprayed hydroxyapatite coatings for use on metallic surgical implants. These tests are designed to characterize the material. NOTE 1 For thin coatings less than 50 μm in thickness, some of the test methods in this document may be difficult to perform without modification. NOTE 2.The requirements for the hydroxyapatite layer of a double coating (consisting of a lower metal coating and an upper hydroxyapatite coating) can comply with this document, but the requirements in this document are If the hydroxyapatite layer in a double coating adopts the requirements of this document, it may be necessary to consider the single layer test. The test specimens represent the rationale for the dual-coated implants. This document does not apply to coatings made from glass, glass ceramics, α- and β-tricalcium phosphate, biphasic calcium phosphate or other forms of calcium phosphate. NOTE 3 Although the requirements in this document are intended as specifications for hydroxyapatite thermal spray coatings, it may be necessary to establish routine control procedures specifying control tests. and their time intervals to ensure that the coating properties remain within specified limits. Note 4.This document focuses on plasma thermal spray coatings of hydroxyapatite. This document is also applicable to the surface treatment of other thermal spray coatings of hydroxyapatite. However, thermal spray coatings without a history of clinical use may present different risks and may require characterization in addition to the ones specified in this document. Additional characterization terms.

2 Normative references

The contents of the following documents constitute the essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document. GB/T 10610 Geometrical Product Specification (GPS) - Rules and methods for evaluating surface structure using the surface texture profile method (GB/T 10610-2009, ISO 4288.1996, IDT) GB/T 16886.1 Biological evaluation of medical devices Part 1.Evaluation and testing in the risk management process (GB/T 16886.1- 2022,ISO 10993-1.2018,IDT) GB/T 23101.3 Hydroxyapatite for surgical implants Part 3.Chemical analysis and characterization of crystallinity and phase purity (GB/T 23101.3-2023,ISO 13779-3.2018,MOD) GB/T 23101.4 Hydroxyapatite for surgical implants Part 4.Determination of adhesion strength of coatings (GB/T 23101.4- 2023, ISO 13779-4.2018, MOD) GB/T 23101.6 Hydroxyapatite for surgical implants Part 6.Powder (GB/T 23101.6-2022, ISO 13779-6. 2015, MOD) YY/T 0988.12 Surgical Implant Coatings Part 12.Shear Test Method for Calcium Phosphate Coatings and Metal Coatings YY/T 0988.14 Surgical Implant Coatings Part 14.Stereological Evaluation Methods for Porous Coatings

3 Terms and Definitions

The terms and definitions defined in GB/T 23101.3 and the following apply to this document.

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