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DIN Standards Committee Optics and Precision Mechanics

Abstract

This document provides specific requirements for knee 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

00285136

Planned document number

DIN EN ISO 21536

Project number

02703209

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 knee-joint replacement implants (ISO/DIS 21536:2021); German and English version prEN ISO 21536:2021
2021-08
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previous edition(s)

Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007 + Amd.1:2014); German version EN ISO 21536:2009 + A1:2014
2014-07