NF EN ISO 10993-16

NF EN ISO 10993-16

November 1997
Standard Cancelled

Biological evaluation of medical devices. Part 16 : toxicokinetic study design for degradation products and leachables.

Main informations

Collections

National standards and national normative documents

Publication date

November 1997

Number of pages

21 p.

Reference

NF EN ISO 10993-16

ICS Codes

11.040.01   Medical equipment in general
11.100.20   Biological evaluation of medical devices

Classification index

S99-516

Print number

1 - 01/10/1997

International kinship

ISO 10993-16:1997

European kinship

EN ISO 10993-16:1997
Table of contents
  • 1
    Domaine d'application 1
  • 2
    Référence normative 1
  • 3
    Définitions 1
  • 4
    Principes de conception des études toxicocinétiques 3
  • 5
    Recommandations relatives aux méthodes d'essais 4
  • 5.1
    Considérations générales 4
  • 5.2
    Recommandations concernant les types d'essais spécifiques 6
  • Annexes
  • A
    Circonstances nécessitant d'envisager des études toxicocinétiques 9
  • B
    Bibliographie 11
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