Evaluating MDs for ED potential.
Phthalates are plasticizers that impart flexibility to plastic products and can leach into their surroundings. Many phthalates have the potential to cause hormonal disruption.
This whitepaper summarizes the evaluation of phthalates and endocrine-disrupting (ED) substances in medical devices (MDs). These substances are referred to as substances of very high concern (SVHC). The overall purpose of this paper is to describe and examine how particular scientific assessment criteria can be used to evaluate MDs for ED potential.
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