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Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables Ingestion-build-205840 discolouration or biochemical deterioration

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Description

discolouration or biochemical deterioration

1 435 mm

Bonding agents specified are intended for use with plasters complying with Class B

The guidance given on inerting is also applicable to prevent an explosion in case of a fire

BS EN 16090 on estimating average grain size by ultrasound is relevant to:

Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables Ingestion-build-205840 discolouration or biochemical deterioration1 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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