ANSI/AAMI/ISO 10993-11:2017 (R2023)

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Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

This document specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.

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Association for the Advancement of Medical Instrumentation [aami]

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Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

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ANSI/AAMI/ISO 10993-11:2017 (R2023)

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

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