British Standards Institution

Source:: ISO
Committee:: CH/150/1 - Materials for surgical implants
Categories:: Implants for surgery, prosthetics and orthotics
Comment period start date:: 19/11/2024
Comment period end date:: 12/01/2025
Number of comments:: 0

Comment by:

12th Jan

Scope

This document specifies a test method for investigating the oxidative stability of ultra-high-molecular-weight polyethylene (UHMWPE) moulded forms as a function of processing and sterilization method. This document describes a laboratory method for accelerated ageing of specimens taken from UHMWPE moulded forms or forms fabricated from these for use in the manufacture of surgical implants. The specimens are 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.

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Please email further comments to: debbie.stead@bsigroup.com

Standard timeline

1. Proposal (Complete)

Proposal start date:

2. Draft (Complete)

Draft start date:

17/09/2024

3. Public Comments

Public Comments start date:

19/11/2024

Public Comments end date:

12/01/2025

Learn more about the standards development process

Standards Development

BS ISO 5834-3 ISO 5834-3 Implants for surgery. Ultra-high-molecular-weight polyethylene. Part 3: Accelerated ageing methods after gamma irradiation in air

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