Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO/FDIS 21535:2023); German version FprEN ISO 21535:2023
Abstract
This document provides specific requirements for hip joint replacement implants. With regard to safety, the document gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and methods of test.
Begin
2019-02-15
WI
00285135
Planned document number
DIN EN ISO 21535
Project number
02703208
Responsible national committee
NA 027-05-05 AA - Endoprosthesis and osteosynthesis
Responsible european committee
CEN/TC 285 - Non-active surgical implants
Responsible international committee
ISO/TC 150/SC 4/WG 4 - General requirements
draft standard
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO/DIS 21535:2021); German and English version prEN ISO 21535:2021
2021-08
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