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EN ISO 10993-11:2006

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

Publication date:   Feb 28, 2007

General information

99.60 Withdrawal effective   Apr 29, 2009

CEN

CEN/TC 206 Biological and clinical evaluation of medical devices

European Norm

11.100   Laboratory medicine

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Scope

This part of ISO 10993 specifies methodologies for the evaluation of the systematic toxicity potential of medical devices with release constituents into the body. In addition, it includes pyrogenicity testing. The test methods cited in this part of ISO 10993 are from International Standards, national standards, directives and regulations. This part of ISO 10993 is concerned with either the actual product or its leachables. It is intended that tests for extracts or leachables be conducted by choosing appropriate extraction vehicles to yield a maximum extraction of leachable materials, in order to conduct biological testing.

Related legislation

Legislation related to this standard

90/385/EEC

Active implantable medical devices

Harmonized/Supporting
Legislation 90/385/EEC
93/42/EEC

Medical devices

Harmonized/Supporting
Legislation 93/42/EEC

Life cycle

PREVIOUSLY

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EN ISO 10993-11:1995

NOW

WITHDRAWN
EN ISO 10993-11:2006
99.60 Withdrawal effective
Apr 29, 2009

REVISED BY

WITHDRAWN
EN ISO 10993-11:2009