NF EN ISO 10993-1

NF EN ISO 10993-1

February 1998
Standard Cancelled

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

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 - 13/02/1998

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
May 2004
Standard Cancelled
Biological evaluation of medical devices - Part 1 : evaluation and testing

ISO 10993-1:2003 describes the general principles governing the biological evaluation of medical devices;the categorization of devices based on the nature and duration of their contact with the body;the selection of appropriate tests. It does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body, nor does it cover biological hazards arising from any mechanical failure. Other parts of ISO 10993 cover specific tests.

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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