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ISO DIS 5834-5 2017 Edition, December 8, 2017 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 5: Morphology assessment method
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Availability date: 07/13/2021
Description / Abstract:
This document specifies the test method for assessing the morphology of UHMWPE moulded forms, which are described in ISO 5834-2. It is not applicable to UHMWPE powder forms, which are described in ISO 5834-1.
NOTE 1 In the field of medical devices it is common to use quality management systems. One possible and widely used quality management system for medical devices is described in ISO 13485.
NOTE 2 Requirements for the competence of testing laboratories can be found in ISO/IEC 17025.
NOTE 3 Performance requirements for this test method have not been established.