T/CAMDI 067-2021 Active Group standards

T/CAMDI 067-2021 Additive manufacturing of tantalum metal spinal prosthesis

Publish Date: 2021-08-11 Implement Date: 2021-08-12 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 067-2021

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2021-08-11

Implement Date: 2021-08-12

Scope

Main technical content: This standard specifies the terms and definitions, expected performance, design attributes, requirements, test methods, cleaning, manufacturing, sterilization, and packaging information for additive manufactured tantalum metal spinal implants. This standard applies to tantalum metal implants manufactured by additive manufacturing methods for replacing human spinal vertebrae, achieving fixation and fusion between vertebrae, and reconstructing spinal stability structures. This standard applies to tantalum metal implants manufactured by powder bed fusion additive manufacturing processes using laser or electron beam as energy sources. Spinal implants manufactured by other additive manufacturing processes and materials can refer to the applicable specific content.