EN ISO 10993-11:2018

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

Publication date:   Sep 18, 2018

General information

60.60 Standard published   May 30, 2018

CEN

CEN/TC 206 Biological and clinical evaluation of medical devices

European Norm

11.100.20   Biological evaluation of medical devices

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Scope

ISO 10993-11:2017 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 legislation

Legislation related to this standard

90/385/EEC

Active implantable medical devices

Harmonized/Supporting
93/42/EEC

Medical devices

Harmonized/Supporting
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

PREVIOUSLY

Replaces
EN ISO 10993-11:2009

NOW

PUBLISHED
EN ISO 10993-11:2018
60.60 Standard published
May 30, 2018