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ANSI/AAMI/ISO 10993-6:2016

ANSI/AAMI/ISO 10993-6:2016

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation

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Specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.

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