GB/T 41428.1-2022 Active National standards

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

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

Publish Date: 2022-04-15 Implement Date: 2023-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 41428.1-2022

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Orthopaedic surgery, orthopaedic instruments

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2022-04-15

Implement Date: 2023-05-01

Pages: 12 pages

Scope

This document specifies the specific requirements for obtaining the necessary bone geometry using medical X-ray tomography equipment, aiming to provide the necessary information for applications such as preoperative design, surgical navigation, robotic surgery, personalized surgical instruments for patients, and personalized total knee joint prostheses. This document sets out the conditions for bone imaging scans and 3D bone model reconstruction.
This document is applicable to the use of medical X-ray tomography equipment to generate 3D bone models.
Note: The capability requirements of CT scan rooms in ensuring the reliability and accuracy of electronic equipment calculations are referred to ISO/IEC 17025.

Development Information

Word Count: 25 Thousand words Pages: 12 pages

Referenced Standards

GB/T 17006.11-2015 Evaluation and routine testing in medical imaging departments—Part 2-6:Constancy tests—Imaging performance of computed tomography X-ray equipment GB/T 17857-1999 Medical radiology—Terminology(Equipment for radiotherapy, nuclear medicine and radiation dosimetry) YY/T 0316-2003 Medical devices—Application of risk management to medical devices YY/T 0316-2008 Medical devices—Application of risk management to medical devices YY/T 0316-2016 Medical devices—Application of risk management to medical devices YY/T 0919-2014 Non-active surgical implants—Joint replacement implants—Specific requirements for knee-joint replacement implants YY/T 0924.1-2014 Implants for surgery—Components for partial and total knee joint prostheses—Part 1:Classification, definitions and designation of dimensions YY/T 0316-2000 YY/T 0316-2000 Medical devices - Risk analysis - Part 1: Application of risk analysis

Adopt standards

ISO 19233-1:2017

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