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ISO 5834-3

Implants for surgery - Ultra-highmolecular- weight polyethylene - Part 3: Accelerated ageing methods

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Organization: ISO
Publication Date: 1 February 2019
Status: active
Page Count: 10
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
scope:

This document specifies a test method for investigating the oxidative stability of ultra-high-molecularweight polyethylene (UHMWPE) materials as a function of processing and sterilization method. This document describes a laboratory method for accelerated ageing of UHMWPE specimens and components for total joint prostheses. The UHMWPE is aged at elevated temperature and at elevated oxygen pressure, to accelerate oxidation of the material and thereby allow for the evaluation of its potential long-term chemical and mechanical stability.

 

Document History

ISO 5834-3
February 1, 2019
Implants for surgery - Ultra-highmolecular- weight polyethylene - Part 3: Accelerated ageing methods
This document specifies a test method for investigating the oxidative stability of ultra-high-molecularweight polyethylene (UHMWPE) materials as a function of processing and sterilization method....
ISO 5834-3
July 15, 2005
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 3: Accelerated ageing methods
This part of ISO 5834 specifies a test method for investigating the oxidative stability of ultra-high-molecularweight polyethylene (UHMWPE) materials as a function of processing and sterilization...

References

This document references:
ASTM F2003 - Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
Published by ASTM on December 10, 2002
It is the intent of this practice to permit an investigator to evaluate the oxidative stability of UHMWPE materials as a function of processing and sterilization method. This practice describes a...
This document references:
ISO 11542-2 - Plastics — Ultra-high-molecular-weight polyethylene (PE-UHMW) moulding and extrusion materials — Part 2: Preparation of test specimens and determination of properties TECHNICAL CORRIGENDUM 1
Published by ISO on June 15, 2007
A description is not available for this item.
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
Published by ISO on October 15, 2014
This part of ISO 14242 specifies the relative angular movement between articulating components, the pattern of the applied force, the speed and duration of testing, the sample configuration, and the...
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 is referenced by:
ISO 5834-4 - Implants for surgery - Ultra-highmolecular- weight polyethylene - Part 4: Oxidation index measurement method
Published by ISO on February 1, 2019
This document specifies a method for the measurement of the relative extent of oxidation present in ultra-high molecular weight polyethylene (UHMWPE). It is applicable to ultra-high molecular weight...
This document is referenced by:
BS ISO 5834-4 - TC - Tracked Changes (Redline) - Implants for surgery - Ultra-high-molecular- weight polyethylene Part 4: Oxidation index measurement method
Published by BSI on February 24, 2020
A description is not available for this item.
This document is referenced by:
BS ISO 16142-1 - TC - Tracked Changes (Redline) - Medical devices — Recognized essential principles of safety and performance of medical devices Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
Published by BSI on February 24, 2020
A description is not available for this item.
This document is referenced by:
ISO 21535 - Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants AMENDMENT 1
Published by ISO on November 15, 2016
A description is not available for this item.
This document is referenced by:
ISO 21536 - Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants
Published by ISO on October 1, 2007
This International Standard provides specific requirements for knee joint replacement implants. With regard to safety, this International Standard specifies requirements for intended performance,...
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