GB/T 41428.1-2022Implants for surgery - Orthopaedic joint prosthesis - Part 1: Procedure for producing parametric 3D bone models from CT data of the knee (English PDF)

1 Scope

This document specifies specific requirements for the use of medical tomography equipment to obtain the necessary bone geometry and is intended for preoperative planning

It provides the necessary information for applications such as metrology, surgical navigation, robotic surgery, patient-personalized surgical instruments, and personalized total knee prostheses. This article

The document gives the conditions for bone image scanning and the conditions for 3D bone model reconstruction.

This file is suitable for the generation of 3D bone models using medical tomography equipment.

Note. See ISO /IEC 17025 for the competence requirements of CT scanning rooms to ensure the reliability and accuracy of calculations of electronic equipment.

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document.

GB/T 17006.11 Evaluation and routine tests of medical imaging departments - Part 2-6.Imaging of X-ray computed tomography equipment

Performance stability test (GB/T 17006.11-2015, IEC 61223-2-6.2006, IDT)

GB/T 17857 Medical Radiology Terminology (Radiotherapy, Nuclear Medicine and Radiation Dosimetry Equipment) (eqvGB/T 17857-1999,

YY/T 0316 Application of Medical Device Risk Management to Medical Devices (YY/T 0316-2016, ISO 14971.2007 Correction version, IDT)

YY/T 0919 Passive Surgical Implants Joint Replacement Implants Particular Requirements for Knee Replacement Implants (YY/T 0919-

2014, ISO 21536.2007, IDT)

YY/T 0924.1 Surgical Implant Parts and Total Knee Prosthesis Parts Part 1.Classification, Definition and Dimensions (YY/T 0924.1-2014, ISO 7207-1.2007, MOD)

3 Terms and Definitions

GB/T 17857, GB/T 17006.11, YY/T 0919, YY/T 0924.1 and the following terms and definitions apply to this document.

ISO and IEC provide databases of terms used in standards at.

3.1

3D bone model 3Dbonemodel

According to the CT image and 3D morphological data, the corresponding skeleton model is reconstructed in the computer. […]