NF EN ISO 10993-16

NF EN ISO 10993-16

July 2010
Standard Cancelled

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

ISO 10993-16:2010 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.

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Main informations

Collections

National standards and national normative documents

Publication date

July 2010

Number of pages

23 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

S99-501-16

Print number

1 - 30/06/2010

International kinship

ISO 10993-16:2010

European kinship

EN ISO 10993-16:2010
Sumary
Biological evaluation of medical devices - Part 16 : toxicokinetic study design for degradation products and leachables

ISO 10993-16:2010 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.

Standard replaced by (1)
NF EN ISO 10993-16
December 2017
Standard Current
Biological evaluation of medical devices - Part 16 : Toxicokinetic study design for degradation products and leachables

<p>ISO 10993-16:2017 provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.</p>

Table of contents
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  • Avant-propos
    iv
  • Introduction
    vi
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    1
  • 4 Principes de conception des études toxicocinétiques
    3
  • 5 Directives relatives aux méthodes d'essai
    4
  • 5.1 Considérations générales
    4
  • 5.2 Directives concernant les types d'essais spécifiques
    5
  • Annexe A (normative) Circonstances nécessitant d'envisager des études toxicocinétiques
    8
  • Bibliographie
    10
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