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Normas DIN – AENOR
DIN EN ISO 10993-16/A1:2009-02

DIN EN ISO 10993-16/A1:2009-02

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997); English version prEN ISO 10993-16:2008, Amendment 1 / Note: Date of issue 2009-02-16

Evaluation biologique des dispositifs médicaux - Partie 16: Conception des études toxicocinétiques des produits de dégration et des substances relargables (ISO 10993-16:1997); Version anglaise prEN ISO 10993-16:2008, Amendement 1 / Attention: Date de parution 2009-02-16

Biologische Beurteilung von Medizinprodukten - Teil 16: Entwurf und Auslegung toxikokinetischer Untersuchungen hinsichtlich Abbauprodukten und Extrakten (ISO 10993-16:1997); Englische Fassung prEN ISO 10993-16:2008, Änderung 1 / Achtung: Erscheinungsdatum 2009-02-16

Fecha Anulación:
2019-08 /Withdrawn
Equivalencias internacionales:

prEN ISO 10993-16 (2008-12)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 10993-16:2009-08

Resumen:
The document gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.
Keywords:
Bioassay, Biological tests, Degradability, Degradation, Design, Determination, Distribution, English language, Evaluations, Experimental design, Experimental set-up, Half-life, Medical devices, Medical equipment, Medical products, Metabolism, Organisms, Test performance, Testing, Toxicity, Toxicokinetic, Toxicological, Toxicological testing, Toxicology
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