GB 23101.1-2008

Active

Implants for surgery - Hydroxyapatite - Part 1: Ceramic hydroxyapatite

外科植入物 羟基磷灰石 第1部分:羟基磷灰石陶瓷

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

This standard specifies the requirements and test methods for ceramic hydroxyapatite used in surgical implants. It applies to the material composition, mechanical properties, and biological safety evaluation of hydroxyapatite ceramics intended for bone graft substitutes, coatings on metallic implants, or other orthopedic and dental applications. The standard ensures consistent quality and performance for medical device manufacturers and regulatory compliance in China.

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.