Biomechanical requirements for certification and quality in medical devices

Author:

Pianigiani Silvia,Villa Tomaso

Publisher

Elsevier

Reference13 articles.

1. Mechanical testing of shoulder prostheses and recommendations for glenoid design;Anglin;Journal of Shoulder and Elbow Surger,2000

2. EN ISO 21534:2009 Non-active surgical implants – Joint replacement implants – Particular requirements. (n.d.). Available at: https://www.iso.org/standard/39024.html.

3. EN ISO 21535 2009 Non-active surgical implants – Joint replacement implants – Specific requirements for hip – joint replacement implants. (n.d.). Available at: https://www.iso.org/standard/40372.html.

4. Investigation on the effects induced by TKA features on tibio-femoral mechanics Part I: Femoral component designs;Innocenti;Journal of Mechanics in Medicine and Biology,2015

5. ISO 14243-1 (2009) Implants for surgery – wear of total knee-joint prostheses – part 1: loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test. (n.d.). Available at: https://www.iso.org/standard/44262.html.

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