Name: EN ISO 10993-16:2017
Brand: CEN

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

Published date

06-12-2017

Publisher

Comite Europeen de Normalisation

European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principles for design of toxicokinetic studies
5 Guidance on test methods
Annex A (normative) - Circumstances in which
        toxicokinetic studies shall be considered
Bibliography
Annex ZA (informative) - Relationship between
         this European Standard and the essential
         requirements of Directive 93/42/EEC
         [OJ L 169] aimed to be covered
Annex ZB (informative) - Relationship between
         this European Standard and the essential
         requirements of Directive 90/385/EEC
         [OJ L 189] aimed to be covered

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.

Committee	CEN/TC 206
DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Current

Standards	Relationship
DIN EN ISO 10993-16:2018-02	Identical
NBN EN ISO 10993-16 : 2010	Identical
UNE-EN ISO 10993-16:2018	Identical
NF EN ISO 10993-16 : 2017	Identical
ONORM EN ISO 10993-16 : 2018	Identical
PN EN ISO 10993-16 : 2010	Identical
NS EN ISO 10993-16 : 2017	Identical
BS EN ISO 10993-16:2010	Identical
ISO 10993-16:2017	Identical
UNE-EN ISO 10993-16:2010	Identical
I.S. EN ISO 10993-16:2010	Identical
SN EN ISO 10993-16 : 2010	Identical
DIN EN ISO 10993-16:2016-04 (Draft)	Identical
UNI EN ISO 10993-16:2018	Identical
PN-EN ISO 10993-16:2018	Identical
NEN EN ISO 10993-16 : 2018	Identical
UNI EN ISO 10993-16 : 2010	Identical
SN EN ISO 10993-16:2018	Identical
I.S. EN ISO 10993-16:2017	Identical
BS EN ISO 10993-16:2017	Identical
DIN EN ISO 10993-16 E : 2010	Identical

ISO/TR 10993-22:2017	Biological evaluation of medical devices — Part 22: Guidance on nanomaterials
ISO 10993-2:2006	Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 10993-18:2005	Biological evaluation of medical devices Part 18: Chemical characterization of materials
ISO 10993-12:2012	Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO 10993-17:2002	Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 14971:2007	Medical devices Application of risk management to medical devices