GB/T 23101.3-2023

Active

Implants for surgery—Hydroxyapatite—Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity

外科植入物 羟基磷灰石 第3部分:结晶度和相纯度的化学分析和表征

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 chemical analysis methods and characterization procedures for determining the crystallinity ratio and phase purity of hydroxyapatite coatings and bulk materials used in surgical implants. It is applied in the medical device industry for quality control and testing of hydroxyapatite-based orthopedic and dental implants to ensure their structural integrity and biocompatibility. The standard is particularly relevant for manufacturers and testing laboratories evaluating the stability and performance of bioactive ceramic coatings on metallic implant substrates.

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.