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EN ISO 10993-11:2006

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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

Withdrawn date

28-02-2007

Published date

15-08-2006

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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.

DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Withdrawn

Standards Relationship
BS EN ISO 10993-11:2006 Identical
UNE-EN ISO 10993-11:2007 Identical

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