EN ISO 10993-16:2017

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

Publication date:   Apr 16, 2018

General information

60.60 Standard published   Dec 6, 2017

CEN

CEN/TC 206 Biological and clinical evaluation of medical devices

European Norm

11.100.20   Biological evaluation of medical devices

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Scope

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.

Related legislation

Legislation related to this standard

90/385/EEC

Active implantable medical devices

Harmonized/Supporting
93/42/EEC

Medical devices

Harmonized/Supporting
2007/47/EC

Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Life cycle

PREVIOUSLY

Replaces
EN ISO 10993-16:2010

NOW

PUBLISHED
EN ISO 10993-16:2017
60.60 Standard published
Dec 6, 2017