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Normas DIN – AENOR
DIN EN ISO 21535:2017-04

DIN EN ISO 21535:2017-04

Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007 + Amd 1:2016); German version EN ISO 21535:2009 + A1:2016

Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences spécifiques relatives aux implants de remplacement de l'articulation de la hanche (ISO 21535:2007 + Amd 1:2016); Version allemande EN ISO 21535:2009 + A1:2016

Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere Anforderungen an Implantate für den Hüftgelenkersatz (ISO 21535:2007 + Amd 1:2016); Deutsche Fassung EN ISO 21535:2009 + A1:2016

Fecha:
2017-04 /Active
Equivalencias internacionales:

EN ISO 21535 (2009-05)

EN ISO 21535/A1 (2016-12)

ISO 21535 AMD 1 (2016-11)

ISO 21535 (2007-10)

Relación con otras normas DIN:
Resumen:
This International Standard provides specific requirements for hip joint replacement implants. With regard to safety, the standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and methods of test. In the present amendment the clause 7.2 "Preclinical evaluation" is revised and updated.
Keywords:
CE marking, Ceramics, Compatibility, Construction details, Data of the manufacturer, Definitions, Design, Fine mechanics, Finishes, Functions, Hinges, Hip joint prostheses, Implants (surgical), Inactive, Joint replacement, Joints, Joints (anatomy), Marking, Materials, Medical devices, Medical equipment, Metals, Motion, Osteosyntheses, Packages, Plastics, Production, Specification (approval), Surgery, Surgical implants, Testing
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