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SRPS EN ISO 10993-16:2018

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

Jun 25, 2018

General information

60.60     Jun 25, 2018

ISS

Z076

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

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

90/385/EEC

Active implantable medical devices

Harmonized
Directive 90/385/EEC
93/42/EEC

Medical devices

Harmonized
Directive 93/42/EEC
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

Directive 2007/47/EC

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS EN ISO 10993-16:2011

NOW

PUBLISHED
SRPS EN ISO 10993-16:2018
60.60 Standard published
Jun 25, 2018

REVISED BY

PROJECT
prSRPS EN ISO 10993-16:2024

Related project

Adopted from EN ISO 10993-16:2017

Adopted from ISO 10993-16:2017