Dehp Medical Devices Reach

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All news - ECHA - Europa

https://www.echa.europa.eu/-/endocrine-disrupting-properties-to-be-added-for-four-phthalates-in-the-authorisation-list

diisobutyl phthalate (DIBP) (EC 201-553-2, CAS 84-69-5). They were identified as substances of very high concern (SVHCs) due to endocrine disrupting properties with effects on human health. DEHP was also identified for its effects on the environment. The …

REACH Authorisation for DEHP in Medical Devices Factsheet

https://www.osservatoriobiomedicaleveneto.it/wp-content/uploads/2020/09/200921_MTE_DEHP-factsheet_FINAL-DRAFT.pdf

Authorisation pillar of the REACH Regulation relevant for DEHP in medical devices: 1. First, there is the process to amend the DEHP entry in Annex XIV (the “Authorisation List”) …

EU REACH Annex XVII: Amendment of phthalate restriction

https://www.tuvsud.com/en/e-ssentials-newsletter/consumer-products-and-retail-essentials/e-ssentials-23-2018/eu-reach-annex-xvii-amendment-of-phthalate-restriction-published

On 18 December 2018, the Official Journal of the European Union (OJEU) published a Regulation (EU) 2018/2005 1, amended the REACH Annex XVII entry 51 of phthalates …

REACH Restrictions for DEHP, DBP, BBP, …

https://www.dekra.com/en/new-bans-on-plasticizers/

The REACH Regulation previously contained only a duty to communicate information in Article 33, as the substances are also on the Candidate List. The extension …

DEHP phthalates in medical devices - GOV.UK

https://www.gov.uk/government/publications/dehp-phthalates-in-medical-devices/dehp-phthalates-in-medical-devices

Di (2-ethylhexyl) phthalate ( DEHP) is the type used the most in medical devices such as: intravenous (IV) tubing umbilical artery catheters blood bags and …

RoHS 3 medical devices - StarFish Medical

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

The restriction of DEHP, BBP, DBP and DIBP shall apply to medical devices, including in vitro medical devices, and monitoring and control instruments, …

DEHP In Medical Devices - B. Braun

https://www.bbraun.com.au/en/stories/dehp-in-medical-devices.html

Diethylhexylphthalate (DEHP) 1 is a phthalate, a chemical substance that is frequently used to soften PVC (Polyvinyl Chloride) medical devices, such as blood bags, tubing, …

Medical devices under REACH and RoHS

https://www.packagingdigest.com/sustainability/medical-devices-under-reach-and-rohs

Implications of REACH for Medical Devices Generating data on the intrinsic properties of chemical substances is the primary objective of the registration process under …

What is DEHP? Where is it used? Why is it used? | U.S.

https://www.usplastic.com/knowledgebase/article.aspx?contentkey=988

REACH is a European chemicals regulation that requires manufacturers to report the substances they use to manufacture their products to the European Chemicals Agency. …

REACH FAQs for Medical Device …

https://www.mddionline.com/regulatory-quality/reach-faqs-medical-device-professionals

REACH stands for Registration, Evaluation, and Authorisation of Chemicals. It is European Union Regulation No 1907/2006. It has many objectives, the …

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