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  • BSI
    BS EN ISO 21535:2024 Non-active surgical implants. Joint replacement implants. Specific requirements for hip-joint replacement implants
    Edition: 2024
    $442.60
    / user per year

Description of BS EN ISO 21535:2024 2024

This document specifies requirements for hip-joint replacement implants. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer and methods of test. This document applies to both total and partial hip joint replacement implants. It applies to components made of metallic and non-metallic materials. This document applies to a wide variety of hip replacement implants, but for some specific hip replacement implant types, some considerations, not specifically covered in this document, can be applicable. Further details are given in 7.2.1.2. The requirements which are specified in this document are not intended to require the re-design or re-testing of implants which have been legally marketed and for which there is a history of sufficient and safe clinical use. For such implants, compliance with this document can be demonstrated by providing evidence of the implant’s sufficient and safe clinical use.

Standard NumberBS EN ISO 21535:2024
TitleNon-active surgical implants. Joint replacement implants. Specific requirements for hip-joint replacement implants
StatusDefinitive
Publication Date2024-07-24
ReplacesBS EN ISO 21535:2009+A1:2016
Identical National Standard OfENISO 21535, ISO 21535
DescriptorsMedical equipment, Implants (surgical), Torsion testing, Marking, Surgical equipment, Dimensional tolerances, Instructions for use, Hips, Performance testing, Angles (geometry), Prosthetic devices, Prosthesis, Orthopaedic equipment, Joints (anatomy), Wear tests, Design, Endurance testing, Orthopaedics
ICS11.040.40 Implants for surgery, prosthetics and orthotics
CommitteeCH/150/4
ISBN978 0 539 03800 2
PublisherBSI
Pages44

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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