T/CAMDI 070-2021 Active Group standards

T/CAMDI 070-2021 Additive manufacturing of polyetheretherketone (PEEK) personalized craniomaxillofacial implant devices

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 070-2021

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 requirements for raw materials, quality evaluation, inspection methods, quality control, manufacturing, sterilization, packaging, and follow-up information of PEEK personalized craniomaxillofacial implant devices primarily processed by additive manufacturing technology. This standard applies to the design and manufacturing specifications of additive-manufactured PEEK implantable medical devices that are surgically implanted into craniomaxillofacial bones for the repair of craniomaxillofacial bone defects, shape modification, retention, and stabilization. This standard covers PEEK polymer raw materials (pellets, powders, filaments, etc.) provided by raw material suppliers. The performance tests in the standard apply to additive-manufactured PEEK craniomaxillofacial implant devices. The performance specified in the standard applies to PEEK polymers, excluding PEEK blends containing glass fiber, carbon fiber, and other fillers, as well as special-design medical devices containing drug components, cells, tissues, and other bioactive substances for 3D bioprinting applications.