T/CAMDI 061-2021 Active Group standards

T/CAMDI 061-2021 Assessment criteria for biological hazards of residual particles in additive manufacturing metal implants

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 061-2021

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Medical materials

Publish Date: 2021-08-11

Implement Date: 2021-08-12

Scope

Main technical content: This standard provides guidance for systematically conducting research on the biological hazards of residual particles in additive manufacturing metal implants, with the aim of evaluating their biological hazards. This standard is applicable to the evaluation of the biological hazards of residual particles in implanted medical devices that come into contact with bone tissue, which are produced using powder bed fusion processes with laser or electron beam as the energy source, and use metal powder as the raw material.