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

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Scope

This document specifies the requirements for single-layer thermally sprayed coatings of
hydroxyapatite used for metallic surgical implants.
These tests are intended to describe the characteristics of the material.
NOTE 1.for thin coatings with a thickness less than 50 m, some of the test methods in this
document may be difficult to implement without modification.
NOTE 2.the requirements for the hydroxyapatite coating of a duplex coating (composed of a lower
metallic coating and an upper hydroxyapatite coating) may comply with this document,
but the test methods described in this document are not applicable to duplex coating. If
the hydroxyapatite layer in the duplex coating takes the requirements of this document
as a reference, then, consideration needs to be given to the rationality of the single-layer
test sample representing the duplex-coated implant.
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 a specification for thermally
sprayed coatings of hydroxyapatite, a routine control procedure may be necessary,
specifying control tests and their time intervals, to ensure that the coating properties
remain within the specified limits.
NOTE 4.this document focuses on plasma thermally sprayed coatings of hydroxyapatite; however,
it is also applicable to the characterization of other thermally sprayed coatings of
hydroxyapatite. However, thermally sprayed coatings without a history record of clinical
use may present different risks and may require additional characterization items beyond
that specified in this document.

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Older Standard (superseded by this standard)	GB 23101.2-2008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