NF EN ISO 10993-11
Biological evaluation of medical devices - Part 11 : tests for systemic toxicity
ISO 10993-11:2017 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
ISO 10993-11:2017 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
<p>ISO 10993-11:2006 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.</p>
- Avant-propos
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1 Domaine d'application
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2 Références normatives
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3 Termes et définitions
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4 Considérations générales
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5 Toxicité systémique aiguë
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6 Toxicité systémique avec exposition répétée (toxicité systémique subaiguë, subchronique et chronique)
- Annexe A (informative) Voies d'administration
- Annexe B (informative) Volumes de dosage
- Annexe C (informative) Signes et observations cliniques courants
- Annexe D (informative) Propositions de mesures en matière d'hématologie, de chimie clinique et d'analyse d'urine
- Annexe E (informative) Proposition de liste d'organes pour l'évaluation histopathologique
- Annexe F (informative) Liste d'organes pour l'histopathologie limitée des dispositifs médicaux soumis à essai de toxicité systémique
- Annexe G (informative) Informations relatives aux pyrogènes véhiculés par des matériaux
- Annexe H (informative) Études subchroniques sur le rat - Doubles voies d'administration parentérale
- Annexe ZA (informative) Relation entre la présente Norme européenne et les exigences essentielles concernées de la Directive européenne 93/42/CEE [JO L 169]
- Annexe ZB (informative) Relation entre la présente Norme européenne et les exigences essentielles concernées de la Directive européenne 90/385/CEE [JO L 189]
- Bibliographie
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