BS ISO 19233-1:2017
Current
The latest, up-to-date edition.
Implants for surgery. Orthopaedic joint prosthesis Procedure for producing parametric 3D bone models from CT data of the knee
Hardcopy , PDF
English
23-06-2017
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and abbreviated terms
4 Principles
5 Requirements
Annex A (informative) - Method of the software validation
Annex B (informative) - CT scanning conditions
Bibliography
Gives requirements for capturing necessary bone geometries, when using a medical X-ray computed tomography apparatus, to provide the information for applications such as preoperative planning, surgical navigation, robotic surgeries, patient matched instruments and personalized total knee joint prosthesis.
| Committee |
CH/150/4
|
| DevelopmentNote |
Supersedes 16/30300186 DC. (06/2017)
|
| DocumentType |
Standard
|
| Pages |
20
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This document provides requirements for capturing necessary bone geometries, when using a medical X-ray computed tomography apparatus, to provide the information for applications such as preoperative planning, surgical navigation, robotic surgeries, patient matched instruments and personalized total knee joint prosthesis. The conditions to scan images of bones and the conditions to reconstruct three-dimensional bone models are provided.
NOTE Requirements for the competence of testing laboratories appropriate to help to ensure the reliability and accuracy of the computational measurements can be found in ISO/IEC17025.
| Standards | Relationship |
| ISO 19233-1:2017 | Identical |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
| ISO 21536:2007 | Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants |
| IEC 61223-2-6:2006 | Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests imaging performance of computed tomography X-ray equipment |
| ISO 7207-1:2007 | Implants for surgery Components for partial and total knee joint prostheses Part 1: Classification, definitions and designation of dimensions |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
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