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ISO DIS 5834-2 2017 Edition, December 8, 2017 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms
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Description / Abstract:
This document specifies the requirements and corresponding test methods for moulded forms, e.g. sheets and rods, made from ultra-high-molecular-weight polyethylene (UHMWPE) for use in the manufacture of surgical implants.
This document is not applicable to direct-moulded (near net shape), irradiated or finished products or products manufactured from polyethylene blended with additives or by blending different forms of polyethylene.
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.