Overview
ISO/IEC 3532-1:2023 - Information technology - Medical image-based modelling for 3D printing - Part 1: General requirements provides high-level requirements for producing accurate 3D data models from medical imaging for additive manufacturing in medical applications. The standard focuses on medical image-based modelling using CT (computed tomography) data, specifying principal considerations for general procedures (image acquisition, segmentation, 3D reconstruction, calibration and validation, and file formats). It explicitly excludes soft-tissue modelling from MRI.
Key topics and technical requirements
- Scope and terminology: Defines terms (voxel, segmentation, surface/volume models, Hounsfield unit, MPR, etc.) and abbreviated terms (CT, DICOM, STL, AMF, PACS, HU).
- Process flow overview: Breaks the 3D printing workflow into phases - image acquisition, segmentation, 3D modelling, and 3D printing - and outlines recommended reporting items (Annex A).
- Medical image acquisition (CT): Addresses requirements for acquiring CT image data suitable for modelling, emphasizing the need for consistent, high-quality source images.
- Segmentation: Requires clear documentation and control of the segmentation process used to isolate anatomy or implants from surrounding tissues.
- 3D reconstruction and visualization: Covers conversion of segmented raster/voxel data to surface/volume models suitable for visualization and additive manufacturing.
- Calibration and validation: Calls for calibration and validation of 2D-to-3D conversion workflows to ensure model accuracy for clinical use.
- File formats and data exchange: Discusses acceptable formats for 3D model exchange (e.g., STL, AMF) and the need to maintain traceability of source medical images (DICOM/PACS).
- Quality control and reporting: Emphasizes documentation, QC measures, and traceability throughout the imaging-to-printing pipeline.
Practical applications and target users
Applications enabled by ISO/IEC 3532-1:2023 include:
- Patient-specific surgical implants and prosthetics
- Surgical guides and fixtures
- Anatomical models for preoperative planning and simulation
- Educational models and device design validation
Primary users and stakeholders:
- Biomedical engineers and 3D printing technicians
- Clinical teams (surgeons, radiologists) involved in patient-specific device workflows
- Medical device manufacturers and service bureaus
- Software developers of segmentation and modelling tools
- Regulatory and quality assurance professionals seeking standard-aligned processes
Related standards
- ISO/IEC 2382 (Information technology - Vocabulary) - terminology used in the standard
- ISO/ASTM 52900 (Additive manufacturing - Fundamentals and Vocabulary) - additive manufacturing concepts referenced
- ISO/ASTM TR 52916 (informative reference for optimized medical image data for additive manufacturing) is noted in the Introduction as helpful complementary guidance.
This standard helps ensure consistent, traceable, and clinically appropriate workflows for converting CT medical images into accurate 3D models for additive manufacturing, supporting safer and more reliable patient-specific medical devices.