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EN ISO 21536:2009 Standard

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  Keywords:

#implants #standard #international #design #replacement

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007)

  Purpose

This International Standard provides specific requirements for knee joint replacement implants. With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer and methods of test

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 21536:2007"

Anyway is still possible use the "EN ISO 21536:2007" until March 21st, 2010

  Related Standards

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EN ISO 14971:2012

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EN ISO 14937:2009

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EN ISO 14889:2009

Medical devices Directive (93/42/EEC)

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