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BS ISO 19233-1:2017

Current
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
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

06-23-2017

Publisher

British Standards Institution

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.

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.

Committee
CH/150/4
DevelopmentNote
Supersedes 16/30300186 DC. (06/2017)
DocumentType
Standard
Pages
20
PublisherName
British Standards Institution
Status
Current
Supersedes

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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Hardcopy - English
PDF - English
Hardcopy - English
PDF - English
Hardcopy - English
PDF - English
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