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SSH EN ISO 10993-16:2017

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

Oct 29, 2018

General information

60.60     Jul 20, 2018

DPS

DPS/KT 206

European Norm

11.100.20  

English  

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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 directives

Directives related to this standards.

90/385/EEC

Active implantable medical devices

Harmonized
93/42/EEC

Medical devices

Harmonized
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

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PUBLISHED
SSH EN ISO 10993-16:2017
60.60 Standard published
Jul 20, 2018

Related project

Adopted from EN ISO 10993-16:2017

Adopted from ISO 10993-16:2017