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 the test method for assessing the morphology of UHMWPE moulded forms as defined in ISO 5834-2.

The assessment of morphology of UHMWPE moulded forms is not required in routine monitoring of validated moulding process because alternative test methods as defined in ISO 5834-2, such as density and mechanical properties, already provide reasonable, redundant assurance of successful consolidation.

This document is not applicable to UHMWPE powder forms, which are described in ISO 5834‑1.

NOTE Performance requirements for this test method have not been established.

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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 5834-5 ISO 5834-5 Implants for surgery. Ultra-high-molecular-weight polyethylene. Part 5: Morphology assessment method

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