Module 14 2022

21/03/2022

Guidelines

ISO 10993 • Provides guidance on how to perform biological evaluation of a device • Describes a matrix of toxicity endpoints that should be considered ISO 14971 • Application of risk management to medical device • Uses information produced in biological assessment to characterize risk

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The Organisation for Professionals in Regulatory Affairs

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Pre-amble

Toxicological hazard • Nature of toxic effects • Dosages at which they occur • The No Observed Adverse Effect Level (NOAEL)

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Toxicological risk • Quantitative assessment of nature of effects in context of amount to which subject is exposed and route of exposure

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The Organisation for Professionals in Regulatory Affairs

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