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SRPS EN ISO 10993-16:2011

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)

May 31, 2011
May 31, 2011
95.99   Withdrawal of Standard   Jun 25, 2018

General information

95.99     Jun 25, 2018

ISS

Z076

European Norm

11.100.20  

Serbian  

From plan 2011

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Scope

ISO 10993-16:2010 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. 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

NOW

WITHDRAWN
SRPS EN ISO 10993-16:2011
95.99 Withdrawal of Standard
Jun 25, 2018

REVISED BY

PUBLISHED
SRPS EN ISO 10993-16:2018

Related project

Adopted from EN ISO 10993-16:2010

Adopted from ISO 10993-16:2010 IDENTICAL