NF EN ISO 10993-16

NF EN ISO 10993-16

December 2017
Standard Current

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

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.

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Main informations

Collections

National standards and national normative documents

Publication date

December 2017

Number of pages

27 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

International kinship

ISO 10993-16:2017

European kinship

EN ISO 10993-16:2017
Sumary
Biological evaluation of medical devices - Part 16 : Toxicokinetic study design for degradation products and leachables

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.

Replaced standards (1)
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.

Table of contents
  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Principes de conception des études toxicocinétiques
  • 5 Directives relatives aux méthodes d'essai
  • Annexe A (normative) Circonstances nécessitant d'envisager des études toxicocinétiques
  • Annexe ZA (informative) Relation entre la présente Norme européenne et les exigences essentielles concernées de la Directive européenne 93/42/CEE [JO L 169]
  • Annexe ZB (informative) Relation entre la présente Norme européenne et les exigences essentielles concernées de la Directive européenne 90/385/CEE [JO L 189]
  • Bibliographie
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