NF EN ISO 10993-1
NF EN ISO 10993-1

NF EN ISO 10993-1

February 1998
Standard Cancelled

Biological evaluation of medical devices. Part 1 : evaluation and testing.

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Main informations

Collections

National standards and national normative documents

Publication date

February 1998

Number of pages

22 p.

Reference

NF EN ISO 10993-1

ICS Codes

11.040.01   Medical equipment in general
11.100.20   Biological evaluation of medical devices

Classification index

S99-501

Print number

1 - février 1998

International kinship

ISO 10993-1:1997

European kinship

EN ISO 10993-1:1997
Replaced standards (1)
NF EN 30993-1
December 1994
Standard Cancelled
Biological evaluation of medical devices. Part 1 : guidance on selection of tests.

Le présent document fournit des lignes directrices concernant : 1) les principes fondamentaux sur lesquels est basée l'évaluation biologique des dispositifs médicaux ; 2) la définition des classes de dispositifs basées sur la nature et la durée de contact avec le corps humain ; 3) le choix des essais appropriés.

Standard replaced by (1)
NF EN ISO 10993-1
January 2004
Standard Cancelled
Biological evaluation of medical devices — Part 1: Evaluation and testing

Table of contents
  • 1 Domaine d'application
    1
  • 2 Définitions
    1
  • 3 Principes généraux applicables à l'évaluation biologique des dispositifs médicaux
    2
  • 4 Classification des dispositifs médicaux
    3
  • 5 Essais
    4
  • 6 Choix des essais d'évaluation biologique
    7
  • 7 Assurance de la qualité des méthodes d'essai
    7
  • Annexe A (informative) Justification
    10
  • Annexe B (informative) Organigramme facilitant l'approche systématique de l'évaluation biologique des dispositifs médicaux
    12
  • Annexe C (informative) Bibliographie
    13
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