ISO 16087:2013 PDF

Overview

ISO 16087:2013 - "Implants for surgery - Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants" defines requirements for using Roentgen stereophotogrammetric analysis (RSA) to measure three‑dimensional migration between orthopaedic implants and host bone. The standard covers terminology, measurement methodology, radiographic setup, calibration, software and coordinate systems, validation (accuracy and precision), and standardized output for clinical RSA studies. CAUTION: RSA uses X‑rays and increases patient radiation exposure; clinical benefit versus risk should be considered.

Key topics and technical requirements

• Markers and virtual markers: Use of small spherical, biocompatible, radio‑opaque markers (e.g., tantalum). Common marker diameters: 0.5 mm, 0.8 mm, 1.0 mm. Virtual markers (defined in the images) can be used to compare specific implant points across studies; a crossing‑line error