GB/T 23101.4-2023

Active

Implants for surgery—Hydroxyapatite—Part 4: Determination of coating adhesion strength

外科植入物 羟基磷灰石 第4部分:涂层粘结强度的测定

Standard Type
GBT
ICS
11.040.40
CCS
C35
Status
Active
Issue Date
2023-11-27
Implementation
2024-12-01
Centralized Committee
国家药监局
Issuing Authority
国家市场监督管理总局、国家标准化管理委员会

Application Summary AI generated

This standard specifies a test method for measuring the adhesion strength of hydroxyapatite coatings applied to surgical implants, such as hip or knee prostheses. It is used by medical device manufacturers and testing laboratories to ensure that the ceramic coating remains securely bonded to the metal substrate under mechanical stress, preventing delamination during implantation or in vivo use. The standard applies specifically to orthopedic and dental implants where hydroxyapatite coatings are used to promote bone integration.

Related Standards

Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.