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
| Autor: | W.H. De Jong, T. Borges, R.M. Ion, D. Panagiotakos, E. Testai, T. Vermeire, U. Bernauer, C. Rousselle, Sté Bégué, H.M. Kopperud, M.R. Milana, T. Schmidt, F. Pignatti, E. Stoyanova, K. Volk, R. Bertollini, P. De Voogt, R. Duarte-Davidson, P. Hoet, R. Kraetke, A. Proykova, T. Samaras, M. Scott, R. Slama, M. Vighi, S. Zacharo |
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| Přispěvatelé: | Freshwater and Marine Ecology (IBED, FNWI) |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
QP Physiology
Medical device business.industry Phthalic Acids Q Science (General) General Medicine Endocrine Disruptors 010501 environmental sciences Toxicology Risk Assessment 030226 pharmacology & pharmacy 01 natural sciences 03 medical and health sciences 0302 clinical medicine Mutagenesis Environmental health RA0421 Public health. Hygiene. Preventive Medicine Carcinogens Humans Medicine Benefit risk assessment business RS Pharmacy and materia medica Mutagens 0105 earth and related environmental sciences |
| Zdroj: | Regulatory toxicology and pharmacology, 111:104546. Academic Press Inc. |
| ISSN: | 1096-0295 0273-2300 |
| DOI: | 10.1016/j.yrtph.2019.104546 |
| Popis: | By the new Medical Device Regulation (MDR, EU 2017/745) the use of certain phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties, above 0.1% by weight (w/w) is only allowed after a proper justification. The SCHEER provide Guidelines on the benefit-risk assessment (BRA) of the presence of such phthalates in certain medical devices.The Guidelines describe the methodology on how to perform a BRA for the justification of the presence of CMR/ED phthalates in medical devices and/or or parts or materials used therein at percentages above 0.1% w/w. They also describe the evaluation of possible alternatives for these phthalates used in medical devices, including alternative materials, designs or medical treatments.Relevant stakeholders e.g. manufacturers, notified bodies and regulatory bodies, can use the guidelines. The approach of these guidelines may also be used for a BRA of other CMR/ED substances present in medical devices.SCHEER noticed that a number of BRA methodologies are theoretically available. However, there is a considerable lack of data needed for the BRA for potential relevant alternatives to be used in medical devices. Therefore, SCHEER encourages manufacturers to generate data of high quality on such alternatives for CMR/ED phthalates in medical devices. |
| Databáze: | OpenAIRE |
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