Module 14 2022

22/03/2022

ISO compliance for materials…

Other important standards ● ISO/TS 21726:2019(en)

Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents ● SCENIHR: The safety of medical devices containing dehp- plasticized pvc or other plasticizers on neonates and other groups possibly at risk ● ASTM F3268-18a: Standard Guide for in vitro Degradation Testing of Absorbable Metals ● ISO/TS 20721:2020(en): Implants for surgery — General guidelines and requirements for assessment of absorbable metallic implants

Masterclass: Lecture 3

The Organisation for Professionals in Regulatory Affairs

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Novel materials…

EXAMPLES: ORIGAMI ENGINEERING http://www.smithsonianmag.com/innovation/new-material-could- make-medical-devices-that-expand-collapse-180958454/

Masterclass: Lecture 3

The Organisation for Professionals in Regulatory Affairs

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