SRPS EN ISO 10993-11:2008

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

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 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.