GB/T 41428.1-2022

Active

Implants for surgery—Orthopaedic joint prosthesis—Part 1: Procedure for producing parametric 3D bone models from CT data of the knee

外科植入物 骨关节假体 第1部分:基于膝关节CT数据生成参数化3D骨模型的流程

Standard Type
GBT
ICS
11.040.40
CCS
C35
Status
Active
Issue Date
2022-04-15
Implementation
2023-05-01
Centralized Committee
国家药监局
Issuing Authority
国家市场监督管理总局、中国国家标准化管理委员会

Application Summary AI generated

This standard specifies the procedure for generating parametric 3D bone models from CT data of the knee, intended for use in the design and production of orthopaedic joint prostheses. It is applied by medical device manufacturers and clinical engineers to create patient-specific or population-based knee models for implant customization, surgical planning, and biomechanical testing. The standard ensures consistency and accuracy in converting medical imaging data into digital models for orthopedic implant development.

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.