SR EN ISO 10993-11:2007

Evaluarea biologică a dispozitivelor medicale. Partea 11: Încercări de toxicitate sistemică

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.

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Informații generale

Status : Anulat
Data aprobării : 12.02.2007
Data publicării : 14.02.2007
Data anulării : 28.02.2010
Număr de pagini : 36
ICS : 11.100.20 Evaluarea biologica a dispozitivelor medicale
Comitet tehnic : 377 - Medicale

Relaţii cu alte standarde:

Inlocuieste SR EN ISO 10993-11:1998
Inlocuit prin SR EN ISO 10993-11:2009