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Normas DIN – AENOR
DIN EN ISO 21534/A1:2009-02

DIN EN ISO 21534/A1:2009-02

Non-active surgical implants - Joint replacement implants - Particular requirements; English version prEN ISO 21534:2008, Amendment 1 / Note: Date of issue 2009-02-16

Implants chirurgicaux non actifs - Implants de remplacement d'articulation - Exigences particulières; Version anglaise prEN ISO 21534:2008, Amendement 1 / Attention: Date de parution 2009-02-16

Nichtaktive chirurgische Implantate - Implantate zum Gelenkersatz - Besondere Anforderungen; Englische Fassung prEN ISO 21534:2008, Änderung 1 / Achtung: Erscheinungsdatum 2009-02-16

Fecha Anulación:
2019-08 /Withdrawn
Equivalencias internacionales:

prEN ISO 21534 (2008-12)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 21534:2009-08

Resumen:
The document specifies particular requirements for total and partial hip joint replacement implants and artificial ligaments hereafter referred to as implants. It specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer. Some tests required to demonstrate conformance to this standard are contained in or referenced in standards for the family of joint replacement implants.
Keywords:
Alloys, Applications, Artificial organs, Biological hazards, Bodies, Bone cements, Ceramics, Checks, Clinical, Construction details, Contact, Data of the manufacturer, Design, English language, Evaluations, Fine mechanics, Finishes, Functional reliability, Functionality, Functions, Hinges, Implants (surgical), Inactive, Information, Joint replacement, Joints, Joints (anatomy), Letterings, Marking, Materials, Measurement, Medical equipment, Medical sciences, Metals, Non-active, Osteosyntheses, Packages, Plastics, Polishing, Position, Production, Replacement, Roughness (surface), Specification (approval), Sterilization (hygiene), Surfaces, Surgery, Surgical implants, Testing, Topography
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