NF EN ISO 10993-11

NF EN ISO 10993-11

May 2018
Standard Current

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.

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Main informations

Collections

National standards and national normative documents

Publication date

May 2018

Number of pages

46 p.

Reference

NF EN ISO 10993-11

ICS Codes

11.040.01   Medical equipment in general
11.100.20   Biological evaluation of medical devices

Classification index

S99-501-11

Print number

1

International kinship

ISO 10993-11:2017

European kinship

EN ISO 10993-11:2018
Sumary
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.

Replaced standards (1)
NF EN ISO 10993-11
September 2009
Standard Cancelled
Biological evaluation of medical devices - Part 11 : tests for systemic toxicity

<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>

Table of contents
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  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Considérations générales
  • 5 Toxicité systémique aiguë
  • 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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