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Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables included-in-kit EN 71-1 also specifies requirements

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EN 71-1 also specifies requirements for packaging

These lamps are intended for domestic and similar general lighting purposes

Paint isn’t just decorative

but visual methods can be subjective

Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables included-in-kit EN 71-1 also specifies requirements1 Scope This document provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.

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