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prSRPS EN ISO 10993-16:2024

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

General information

10.99    

ISS

Z076

European Norm

English  

Scope

ISO 10993-16:2017 provides principles on designing and performing toxicokinetic evaluation relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic evaluation 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.

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Life cycle

PREVIOUSLY

PUBLISHED
SRPS EN ISO 10993-16:2018

NOW

PROJECT
prSRPS EN ISO 10993-16:2024
10.99 New project approved

Related project

Adopted from prEN ISO 10993-16 rev IDENTICAL

Adopted from ISO/CD 10993-16 IDENTICAL