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

Le présent document donne des principes de conception et de mise en oeuvre des études toxicocinétiques applicables aux dispositifs médicaux, afin d'évaluer l'innocuité des matériaux utilisés. L'Annexe A fait état des cas où les études toxicocinétiques doivent être envisagées.

Table of contents
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  • 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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