2. GUIDELINES on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties

GUIDELINES on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties

Edited on 06/27/2023
File: 
PDF icon guidelines_benefit-risk_assessment_phthalates_medical_devices.pdf
Author: 
Commission Européenne
Year of publication: 
2019
Source type: 
Institutionnel
Description: 

Ce guide fournit des lignes directrices pour évaluer les risques/bénéfices des phtalates (classés CMR1 ou PE2) et de leurs alternatives dans les dispositifs médicaux en vue de les comparer et ainsi potentiellement éviter une substitution regrettable.

1 Cancérigène Mutagène Reprotoxique

2 Perturbateur endocrinien