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About This Item

 

Full Description

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.

 

Document History

  1. DANSK DS/EN ISO 21536


    Non-active surgical implants – Joint replacement implants – Specific requirements for knee-joint replacement implants (ISO 21536:2023)

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  2. DANSK DS/EN ISO 21536

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    Non-active surgical implants – Joint replacement implants – Specific requirements for knee-joint replacement implants

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. DANSK DSF/PREN ISO 21536


    Non-active surgical implants – Joint replacement implants – Specific requirements for knee-joint replacement implants (ISO/DIS 21536:2021)

  2. DANSK DS/EN ISO 21536/A1


    Non-active surgical implants – Joint replacement implants – Specific requirements for knee-joint replacement implants – Amendment 1