NF EN ISO 10993-1

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.

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Main informations

Collections

National standards and national normative documents

Publication date

May 2004

Number of pages

24 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 - 13/12/2004

International kinship

ISO 10993-1:2003

European kinship

EN ISO 10993-1:2003
Sumary
Biological evaluation of medical devices - Part 1 : evaluation and testing

ISO 10993-1:2003 describes

  1. the general principles governing the biological evaluation of medical devices;
  2. the categorization of devices based on the nature and duration of their contact with the body;
  3. 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.

Replaced standards (1)
NF EN ISO 10993-1
February 1998
Standard Cancelled
Biological evaluation of medical devices. Part 1 : evaluation and testing.

Table of contents
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  • Avant-propos
    iv
  • Introduction
    vi
  • 1 Domaine d'application
    1
  • 2 Termes et définitions
    1
  • 3 Principes généraux applicables à l'évaluation biologique des dispositifs médicaux
    2
  • 4 Classification des dispositifs médicaux
    3
  • 5 Essais
    5
  • 6 Choix des essais d'évaluation biologique
    8
  • 7 Assurance de la qualité des méthodes d'essai
    8
  • Annexe A (informative) Justification
    11
  • Annexe B (informative) Organigramme facilitant l'approche systématique de l'évaluation biologique des dispositifs médicaux
    13
  • Bibliographie
    14
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