ISO 12836:2015

Overview

ISO 12836:2015 - "Dentistry - Digitizing devices for CAD/CAM systems for indirect dental restorations - Test methods for assessing accuracy" specifies standardized test methods to evaluate the accuracy of digitizing devices used in dental CAD/CAM workflows. The standard targets lab-based optical and mechanical-contact scanners (not hand-held scanners) and excludes radiographic (X‑ray) and MRI digitization. It defines how to measure accuracy as the combined concepts of trueness and precision using controlled specimens and reporting formats.

Key topics and requirements

• Scope & exclusions: Applies to mounted, non‑handheld digitizing devices for indirect restorations; excludes X‑ray and MRI methods.
• Accuracy concepts: Uses ISO definitions of trueness, precision, repeatability, reproducibility, systematic error and random error to quantify scanner performance.
• Test specimens (Annexes A–C):
  • Inlay‑cavity die (simulates sharp edges of inlay preparations)
  • Crown‑and‑bridge preparation die (multi‑unit specimen; two core dies with 30 mm centre‑to‑centre distance for bridge simulation)
  • Sphere (measurement limited to the upper hemisphere)
• Data product: Recognizes the matched point cloud and resulting tessellation in STL format as the scanner output used for assessment.
• Test methods & conditions: Procedures cover repeatability, reproducibility, and trueness assessments under specified environmental and conditioning requirements (referencing ISO 554).
• Calibration & reporting: Manufacturers must provide device‑specific instructions and accuracy information; test reports must document methods, conditions, and measurement results.

Practical applications

• Compare and validate dental lab scanners and bench-top digitizing devices for CAD/CAM restorations.
• Support quality control and acceptance testing in dental laboratories and manufacturing facilities.
• Inform procurement decisions by objectively comparing trueness and precision across devices.
• Guide R&D and regulatory testing for scanner manufacturers and conformity assessment bodies.
• Provide standardized data for academic research in dental digitization and occlusion measurements.

Who uses this standard

• Dental scanner and CAD/CAM system manufacturers
• Dental laboratories and prosthodontic facilities
• Test laboratories and conformity assessors
• Regulatory bodies, clinical researchers, and academic institutions

Related standards

• ISO 5725‑1 (accuracy - trueness and precision)
• ISO 1942 (dentistry vocabulary)
• ISO/IEC Guide 99 (VIM)
• ISO 554 (standard atmospheres for testing)
• ISO 3290‑2 (reference for ceramic balls used in sphere specimens)

Keywords: ISO 12836:2015, dentistry digitizing devices, CAD/CAM accuracy, trueness, precision, repeatability, reproducibility, dental scanner testing, STL.