T/CAMDI 115-2023 Active Group standards

T/CAMDI 115-2023 Additive manufacturing biomechanically-adaptive titanium alloy intervertebral fusion device

Publish Date: 2023-12-28 Implement Date: 2023-12-31 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 115-2023

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2023-12-28

Implement Date: 2023-12-31

Pages: 14 pages

Scope

Main technical content: This document specifies the terms and definitions, expected performance, design attributes, requirements, test methods, manufacturing, cleaning, sterilization, packaging, and manufacturer-provided information for additive manufactured biomechanical adaptive intervertebral fusion devices. This document applies to biomechanical adaptive intervertebral fusion devices manufactured by additive manufacturing methods for placement in the intervertebral disc position to provide mechanical support for intervertebral fusion. This document applies to TC4 or TC4 ELI material intervertebral fusion devices manufactured by powder bed fusion additive manufacturing using electron beams or lasers as energy sources. Intervertebral fusion devices manufactured by other additive manufacturing processes and/or materials can refer to the applicable content of this document.