NF EN ISO 10993-11

NF EN ISO 10993-11

September 2009
Standard Cancelled

Biological evaluation of medical devices - Part 11 : tests for systemic toxicity

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.

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Collections

National standards and national normative documents

Publication date

September 2009

Number of pages

37 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 - 17/09/2009

International kinship

ISO 10993-11:2006

European kinship

EN ISO 10993-11:2009
Sumary
Biological evaluation of medical devices - Part 11 : tests for systemic toxicity

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.

Replaced standards (1)
NF EN ISO 10993-11
January 2007
Standard Cancelled
Biological evaluation of medical devices - Part 11 : tests for systemic toxicity

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.

Standard replaced by (1)
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.

Table of contents
  • Avant-propos
    iv
  • Introduction
    vi
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    1
  • 4 Considérations générales
    3
  • 4.1 Généralités
    3
  • 4.2 Sélection d'une espèce animale
    3
  • 4.3 État de l'animal
    3
  • 4.4 Soins portés aux animaux et élevage
    3
  • 4.5 Taille et nombre des groupes
    4
  • 4.6 Voie d'exposition
    5
  • 4.7 Préparation des échantillons
    5
  • 4.8 Dosage
    5
  • 4.9 Masse corporelle et consommation d'eau et de nourriture
    6
  • 4.10 Observations cliniques
    6
  • 4.11 Pathologie clinique
    7
  • 4.12 Pathologie anatomique
    7
  • 4.13 Conception des études
    8
  • 4.14 Qualité des enquêtes
    8
  • 5 Toxicité systémique aiguë
    8
  • 5.1 Généralités
    8
  • 5.2 Conception de l'étude
    9
  • 5.3 Critères d'évaluation
    10
  • 5.4 Rapport final
    11
  • 6 Toxicité systémique avec exposition répétée (toxicité systémique subaiguë, subchronique et chronique)
    13
  • 6.1 Généralités
    13
  • 6.2 Conception de l'étude
    13
  • 6.3 Critères d'évaluation
    16
  • 6.4 Rapport final
    16
  • Annexe A (informative) Voies d'administration
    17
  • Annexe B (informative) Volumes de dosage
    19
  • Annexe C (informative) Signes et observations cliniques courants
    20
  • Annexe D (informative) Propositions de mesurages en matière d'hématologie, de chimie clinique et d'analyse d'urine
    21
  • Annexe E (informative) Proposition d'une liste d'organes pour évaluation histopathologique
    23
  • Annexe F (informative) Informations sur les réponses pyrogènes véhiculées par des matériaux
    25
  • Bibliographie
    27
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