GB 23101.2-2008

Active

Implants for surgery - Hydroxyapatite - Part 2: Coatings of hydroxyapatite

外科植入物 羟基磷灰石 第2部分:羟基磷灰石涂层

Standard Type
GB
ICS
11.040.40
CCS
C35
Status
Active
Issue Date
2008-12-30
Implementation
2010-03-01
Centralized Committee
国家药监局
Issuing Authority
中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会

Application Summary AI generated

GB 23101.2-2008 specifies requirements for hydroxyapatite coatings applied to surgical implants, including chemical composition, crystallinity, and adhesion strength. It is used in the medical device industry for quality control and testing of orthopedic and dental implants, such as hip stems or bone screws, where the coating promotes bone bonding. This standard ensures coating consistency and biocompatibility for implants intended for long-term human implantation.

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.