T/CAMDI 045-2020 Active Group standards

T/CAMDI 045-2020 3D Printing Metal Implant Finite Element Analysis Method

Publish Date: 2020-06-18 Implement Date: 2020-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CAMDI 045-2020

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Orthopaedic surgery, orthopaedic instruments

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2020-06-18

Implement Date: 2020-07-01

Scope

Main technical content: This standard specifies the requirements, methods, and reporting content for numerical simulation analysis of 3D printed metal implants using finite element analysis (FEA) technology. This standard applies to the finite element analysis of the structural performance of related final products of 3D printed metal implants conducted during the product design and verification stages, focusing on product mechanical performance, motion function, and biological function. Based on this standard, the performance evaluation of 3D printed metal implants under clinical or experimental equivalent conditions can serve as a reference basis for the product design and verification stages. If it is used as the final evaluation basis for obtaining the true reliability of the product, corresponding data from in vitro experiments and animal experiments should be added.