99.60 Withdrawal effective Apr 29, 2009
CEN
CEN/TC 206 Biological and clinical evaluation of medical devices
European Norm
11.100 Laboratory medicine
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.
Legislation related to this standard
WITHDRAWN
EN ISO 10993-11:1995
WITHDRAWN
EN ISO 10993-11:2006
99.60
Withdrawal effective
Apr 29, 2009
WITHDRAWN
EN ISO 10993-11:2009