GB/T 12417.1-2008

Abolished

Non-active surgical implants - Osteosynthesis and joint replacement implants - Part 1: Particular requirements for osteosynthesis implants

无源外科植入物 骨接合与关节置换植入物 第1部分:骨接合植入物特殊要求

Standard Type
GBT
ICS
11.040.40
CCS
C35
Status
Abolished
Issue Date
2008-12-15
Implementation
2010-02-01
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 particular requirements for non-active surgical implants used in osteosynthesis, such as bone plates, screws, and intramedullary nails. It is applied in the design, manufacturing, and testing of these implants to ensure mechanical performance, biocompatibility, and safety for fracture fixation in orthopedic surgery. The standard is relevant for medical device manufacturers, regulatory bodies, and clinical settings 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.