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NF EN ISO 10993-11 : 2009

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY

Withdrawn date

23-02-2019

Published date

12-01-2013

Avant-propos
Introduction
1 Domaine d'application
2 Références normatives
3 Termes et définitions
4 Considérations générales
  4.1 Généralités
  4.2 Sélection d'une espèce animale
  4.3 État de l'animal
  4.4 Soins portés aux animaux et élevage
  4.5 Taille et nombre des groupes
  4.6 Voie d'exposition
  4.7 Préparation des échantillons
  4.8 Dosage
  4.9 Masse corporelle et consommation d'eau et de
       nourriture
  4.10 Observations cliniques
  4.11 Pathologie clinique
  4.12 Pathologie anatomique
  4.13 Conception des études
  4.14 Qualité des enquêtes
5 Toxicité systémique aiguë
  5.1 Généralités
  5.2 Conception de l'étude
  5.3 Critères d'évaluation
  5.4 Rapport final
6 Toxicité systémique avec exposition répétée (toxicité
  systémique subaiguë, subchronique et chronique)
  6.1 Généralités
  6.2 Conception de l'étude
  6.3 Critères d'évaluation
  6.4 Rapport final
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 mesurages en
         matière d'hématologie, de chimie clinique et
         d'analyse d'urine
Annexe E (informative) Proposition d'une liste d'organes
         pour évaluation histopathologique
Annexe F (informative) Informations sur les réponses
         pyrogènes véhiculées par des matériaux
Bibliographie

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.

DevelopmentNote
Indice de classement: S99-501-11PR. PR NF EN ISO 10993-11 April 2005. (04/2005) PR NF EN ISO 10993-11 February 2009. (02/2009) PR NF EN ISO 10993-11 January 2016. (02/2016)
DocumentType
Standard
PublisherName
Association Francaise de Normalisation
Status
Withdrawn
SupersededBy

XP S94 091 : 2008 XP IMPLANTS FOR SURGERY - VALIDATION OF THE CLEANING OF ORTHOPAEDIC IMPLANTS BEFORE FINAL CONDITIONING
NFS 94 091 : 2013 IMPLANTS CHIRURGICAUX - EXIGENCES DE VALIDATION POUR LE PROCEDE DE NETTOYAGE DES IMPLANTS ORTHOPEDIQUES AVANT CONDITIONNEMENT FINAL
NF EN ISO 7405 : 2009 AMD 1 2013 DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY

NF EN ISO 10993-12 : 2012 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS
NF EN ISO 10993-1 : 2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT SYSTEM PROCESS
NF EN ISO 10993-2 : 2006 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 2: ANIMAL WELFARE REQUIREMENTS

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