GB/T 12417.2-2025

Active

Non-active surgical implants—Osteosynthesis and joint replacement implants—Part 2: Particular requirements for joint replacement implants

无源外科植入物 骨接合与关节置换植入器械 第2部分:关节置换植入器械特殊要求

Standard Type
GBT
ICS
11.040.40
CCS
C35
Status
Active
Issue Date
2025-02-28
Implementation
2026-03-01
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 particular requirements for joint replacement implants, including materials, design, mechanical performance, and sterilization. It is applied in the manufacturing and quality control of artificial hip, knee, and shoulder implants used in orthopedic surgery. The standard ensures these medical devices meet safety and performance criteria for clinical 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.