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ISO 21535

Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants

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Organization: ISO
Publication Date: 1 October 2007
Status: active
Page Count: 16
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
scope:

This International Standard provides specific requirements for hip joint replacement implants. With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer, and methods of test.

Document History

21535
July 1, 2023
Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants
This document specifies requirements for hip-joint replacement implants. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design...
ISO 21535
November 15, 2016
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants AMENDMENT 1
A description is not available for this item.
ISO 21535
October 1, 2007
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
This International Standard provides specific requirements for hip joint replacement implants. With regard to safety, this International Standard specifies requirements for intended performance,...
ISO 21535
November 1, 2002
Non-Active Surgical Implants - Joint Replacement Implants - Specific Requirements for Hip-Joint Replacement Implants
A description is not available for this item.

References

This document references:
ISO 7206-1 - Implants for surgery — Partial and total hip joint prostheses — Part 1: Classification and designation of dimensions
Published by ISO on April 1, 2008
This part of ISO 7206 provides a means of classification and standardizes the designation of dimensions for partial and total hip joint prostheses.
This document references:
ISO 14242-2 - Implants for surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement
Published by ISO on September 15, 2016
This part of ISO 14242 specifies methods of assessment of wear of the acetabular component of total hip-joint prostheses using gravimetric techniques and changes in dimensional form of components...
This document references:
ISO 14242-1 - Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test AMENDMENT 1
Published by ISO on July 1, 2018
A description is not available for this item.
This document references:
ISO 7206-1 - Implants for surgery — Partial and total hip joint prostheses — Part 1: Classification and designation of dimensions
Published by ISO on April 1, 2008
This part of ISO 7206 provides a means of classification and standardizes the designation of dimensions for partial and total hip joint prostheses.
This document references:
ISO 7206-4 - Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components AMENDMENT 1
Published by ISO on March 15, 2016
A description is not available for this item.
This document is referenced by:
EN ISO 14630 - Non-active surgical implants - General requirements
Published by CEN on December 1, 2012
This International Standard specifies general requirements for non-active surgical implants, hereafter referred to as implants. This International Standard is not applicable to dental implants,...
This document is referenced by:
SN EN ISO 14630 - Non-active surgical implants - General requirements
Published by SNV on March 1, 2013
This International Standard specifies general requirements for non-active surgical implants, hereafter referred to as implants. This International Standard is not applicable to dental implants,...
This document is referenced by:
ASTM F2582 - Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components
Published by ASTM on November 15, 2020
This test method covers a procedure to simulate dynamic impingement between femoral and acetabular components in a hip replacement; the subsequent qualitative assessment of damage modes (as outlined...
This document is referenced by:
ASTM F2091 - Standard Specification for Acetabular Prostheses
Published by ASTM on March 15, 2015
This specification covers acetabular resurfacing devices used to provide a functioning articulation between the bones of the acetabulum and the femur. This specification is intended to provide basic...
This document is referenced by:
BS EN ISO 14630 - Non-active surgical implants - General requirements
Published by BSI on December 31, 2012
A description is not available for this item.
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