This document specifies the in vivo examination required for the biological assessment of three-dimensional (3D) bio-printed polymeric scaffolds intended for use in bone regeneration. 3D bio-printed scaffolds are gaining increased attention and animal experiments are fundamental in assessing their performance prior to potential clinical use. In vivo assessment will include the following features. Animal model include rat or rabbit. Bone defect can be created on the skull, femur or pelvis. The defect size is minimum 5mm3 in volume. Assessment include histopathological, radiological and mechanical assessment.
Working Group Details
Standard for Three-Dimensional (3D) Medical Visualization
This standard focuses on the demands arising when scientific results in the field of 3D medical visualization are applied for the construction of a software system. It is targeted to aid the clinical work of medical professionals. This standard includes visualization techniques by the automated medical shape detection and reconstruction of three-dimensional (3D) models from two-dimensional medical images. Also it contains texturing of three-dimensional medical data for the intuitive visualization.
Standard for Three-Dimensional (3D) Medical Data Management
This standard includes medical 2D and 3D data management such as storage, compression for transfer, regulation for wired or wireless transfer and search engine development for data retrieval.
Standard for Three-Dimensional (3D) Medical Simulation
This standard discusses the simulation of the movement of joints and subsequent changes of skin, muscle, and neighboring structures. It defines joint range of motion, movement, and structure of skeleton for rigging work. Additionally, it reviews simulation devices such as haptic devices or software and hardware based on reality augmented equipment.
Standard for Soft Tissue Modeling for Medical 3D Printing
This standard describes a defined model data file format standard for consistent 3D printing that reduces the 3D printing output variability of soft tissue in medical images. Standardization involves acquiring model data with physical density and size characteristics through medical tomography image calibration and developing digital file format data using image segmentation technology.
Standard for Hard Tissue Modeling for 3D Printing
This standard defines a data file format standard that increases the precision of 3D printing model output of hard tissues in medical images. Standardization involves the use of medical scanning devices to acquire physical data models with density and size characteristics and to develop comparative analysis data.
Standard for Surgical Guide Design Modeling for Medical 3D Printing
This standard defines patient-specific guide block design and 3D modeling technology standards for high-precision 3D printing to increase patient satisfaction with orthopedic implant surgeons.
Standard for Artificial Joint Implant Design Modeling for Medical 3D Printing
This standard defines the optimal design elements for medical 3D printing based on the analysis of the technical elements of artificial joint outputs required by the orthopedic surgeon, the patient's affected three-dimensional model data, and artificial joint templates. Standardization includes medical three-dimensional models such as the location, orientation and shape of orthopedic osteotomy, and patient-specific artificial joint model data for 3D printing.