• 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

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  23-06-2017

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    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.

    Scope - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Committee CH/150/4
    Development Note Supersedes 16/30300186 DC. (06/2017)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    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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