Phthalates Directive Medical Devices

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Guidance for Industry - Food and Drug Administration

https://www.fda.gov/media/83029/download

Phthalate esters (phthalates) are synthetic chemicals with a broad spectrum of uses. Phthalates are found in certain pharmaceutical formulations, primarily as a plasticizer in...

Guidelines on phthalates in medical devices - Public Health

https://health.ec.europa.eu/other-pages/health-sc-basic-page/guidelines-phthalates-medical-devices_en

Guidelines on phthalates in medical devices Page contents Final version of the Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices …

Guideline on the use of phthalates as excipients in …

https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-use-phthalates-excipients-human-medicinal-products_en.pdf

Phthalates are used as functional excipients in a large number of oral pharmaceutical formulations. They are most commonly used as plasticizing agents in enteric film-coating …

Phthalates - ECHA - Europa

https://echa.europa.eu/hot-topics/phthalates

Phthalates form a family of synthetic chemicals with a wide variety of uses, ranging from consumer to industrial products. There are different kind of phthalates and …

RoHS 3 medical devices - StarFish Medical

https://starfishmedical.com/blog/rohs-3-impact-on-medical-devices/

RoHS 3 (EU 2015/863) expands the list of prohibited substances from six to ten by adding four new types of phthalates. This …

Phthalates | ICU Medical

https://www.smiths-medical.com/company-information/corporate-responsibility/phthalates

The European Directive 2007/47/EC makes several amendments to the Medical Devices Directive (MDD) 93/42/EEC that was implemented in 1995. One of the amendments …

REACH: New authorization requirements for certain phthalates in …

https://www.produktkanzlei.com/en/2021/11/30/reach-new-authorization-requirements-for-certain-phthalates-in-medical-devices-food-contact-materials-and-packaging-of-medicinal-products/

The four phthalates bis (2-ethylhexyl)phthalate (DEHP, EC: 204-211-0, CAS: 117-81-7), benzyl butyl phthalate (BBP, EC: 201-622-7, CAS: 85-68-7), dibutyl …

Phthalate Regulations in the United States: An Overview

https://www.compliancegate.com/phthalate-regulations-united-states/

What are Phthalates? Phthalates are a group of chemicals that are often added to plastics, rubber, coating materials, and adhesives to enhance the flexibility, transparency, and longevity of these products. In …

Phthalate Regulations in the European Union: An …

https://www.compliancegate.com/phthalate-regulations-european-union/

Phthalates are used in a large variety of consumer products such as: Toys Food contact materials Cosmetics Product packaging Household products Medical …

RoHS Directive Compliance for Medical Devices | TÜV …

https://www.tuvsud.com/en-us/industries/healthcare-and-medical-devices/medical-devices-and-ivd/restricted-hazardous-substances

New restricted substances that come into effect on 22 July 2019 for Electrical and Electronic Equipment (EEE); and 22 July 2021 for medical devices, in-vitro medical devices and …

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