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SSH EN ISO 10993-11:2009

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

Jun 17, 2009
95.99 Withdrawal of Standard   Apr 24, 2019

General information

95.99     Apr 24, 2019

DPS

DPS/KT 206

European Norm

11.100.20  

English  

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Scope

ISO 10993-11:2006 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.

Related directives

Directives related to this standards.

93/42/EEC

Medical devices

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

Active implantable medical devices

Harmonized
Directive 90/385/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WITHDRAWN
SSH EN ISO 10993-11:2006

NOW

WITHDRAWN
SSH EN ISO 10993-11:2009
95.99 Withdrawal of Standard
Apr 24, 2019

REVISED BY

PUBLISHED
SSH EN ISO 10993-11:2018

Related project

Adopted from EN ISO 10993-11:2009