T/CSBM 0023-2022 Active Group standards

T/CSBM 0023-2022 3D Printed Personalized Titanium Alloy Mandible Reconstruction Implant

Publish Date: 2022-04-12 Implement Date: 2022-10-01 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/CSBM 0023-2022

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2022-04-12

Implement Date: 2022-10-01

Pages: 14 pages

Scope

Main Technical Content: 1. Requirements 1.1 Prosthetic CAD Design Model 1.1.1 The design requirements and main structural scheme of personalized implants shall be proposed by the attending physician. 1.1.2 The extension fixing plate and mandibular body (main body) of personalized implants require a stable and reliable connection. The thickness of the extension fixing plate shall be ≥1mm, preferably 2.0mm–2.4mm; the transition radius between the extension fixing plate and mandibular body shall be ≥1mm; the lower edge of the extension plate should extend beyond the mandibular lower edge; the number of screw holes on the extension plate shall be ≥3, distributed in an X-shaped pattern, i.e., the screw holes should be staggered between adjacent rows; the inner surface of the extension plate shall be reverse-engineered directly from the residual mandibular bone (healthy side) on the buccal surface of the patient, and the average error between the model surface before and after smoothing processing of the CAD model shall be ±0.1mm. 1.1.3 When the mandibular body (main body) of personalized implants is a solid structure, the cross-sectional shape of the body shall be smooth to avoid irritating soft tissues. 1.1.4 When the mandibular body (main body) of personalized implants is a plate-like structure (bone plate), the height of the body shall not exceed the apex of the tooth root, and the surface smoothness error of the body shall be ±0.2mm. 1.1.5 When there are lesions or defects in the joint (condyle) of personalized implants, the side joint mirror data can be used for joint reverse-engineering design, but the height of the condyle should be appropriately reduced according to the doctor's requirements, generally by 1mm–2mm, and appropriately scaled down in linear proportion. For fresh lesions or defects in the joint, it is recommended to reduce the condyle by 5%–8%, and for old lesions or defects, it is recommended to reduce the condyle by 10%–15%. 1.1.6 Af