Overview
ISO/IEC 3532-2:2024 - Information technology - Medical image‑based modelling for 3D printing - Part 2: Segmentation - defines a standardized process for medical image segmentation of human bone used in medical 3D modelling and 3D printing systems. The standard covers the end‑to‑end segmentation workflow (data preparation, preprocessing, annotation, model selection, evaluation, deployment and post‑processing) and aims to improve performance, consistency and traceability of bone segmentation from CT and MR images.
Key topics and requirements
- Scope: Focus on segmentation for human bone and applicability to medical 3D printing systems that include modelling capabilities.
- Segmentation process: Seven main steps are specified - data preparation, preprocessing for segmentation, annotation, selection of segmentation network model, performance evaluation, model deployment/running, and post‑processing.
- Imaging considerations: Guidance on medical image acquisition and reconstruction (CT, MR), with annexes addressing CT scanning for orbital bone and characteristics of orbital bone segmentation.
- Preprocessing: Intensity normalization and spacing normalization to standardize inputs across datasets.
- Annotation and dataset management: Procedures for data labelling, preprocessing for annotation, training/testing splits and augmentation to support robust model training.
- Model selection and deep learning: Considerations for network architecture, input patching and use of deep learning techniques (informative annex).
- Evaluation and verification: Requirement to define evaluation metrics and procedures to quantify segmentation performance and to perform verification before 3D model generation.
- Post‑processing and deployment: Steps for refining segmentation outputs and integrating models into medical 3D printing workflows.
- Informative annexes: Practical guidance on CT scanning conditions, orbital bone segmentation challenges, deep learning techniques, and overall performance considerations.
Applications and users
ISO/IEC 3532-2:2024 targets organizations and professionals involved in medical 3D modelling and additive manufacturing, including:
- Medical device and surgical implant manufacturers
- Hospitals and clinical teams (radiologists, surgeons involved in preoperative planning, cranio‑maxillofacial specialists)
- Medical imaging and 3D printing software vendors
- Biomedical engineers, clinical engineers and AI developers working on segmentation models
- Regulatory and quality teams seeking standardized validation and traceability for patient‑specific devices
Practical applications include surgical planning, patient‑specific implant design (e.g., orbital wall reconstruction), anatomical modelling for education, and clinical workflow integration for medical 3D printing.
Related standards
- ISO/ASTM 52950 - Additive manufacturing - General principles - Overview of data processing
- ISO 15708‑1 - Non‑destructive testing - Radiation methods for computed tomography - Terminology
- ISO/IEC 2382 - Information technology - Vocabulary
Keywords: ISO/IEC 3532-2:2024, medical image segmentation, bone segmentation, CT segmentation, MR segmentation, 3D printing, medical 3D modelling, deep learning, annotation, preprocessing, segmentation evaluation.