Eliminating DEHP Plasticizer in-Medical Design Briefs Egypt

  • Eliminating DEHP Plasticizer in-Medical Design Briefs Egypt
  • Eliminating DEHP Plasticizer in-Medical Design Briefs Egypt
  • Eliminating DEHP Plasticizer in-Medical Design Briefs Egypt
  • When can DEHP be used in medical devices?
  • Under the EU Medical Device Regulation, the continued use of DEHP in medical devices after 31 December 2027 for high-risk devices and 31 December 2028 for medium- and low-risk devices requires a justification according to the latest relevant scientific committee guidelines.
  • Can plasticisers replace DEHP in blood bags?
  • The plasticiser industry has invested more than €6 billion in developing safe alternatives. For medical applications, the European Pharmacopoeia lists since 2016 the following plasticisers as replacements for DEHP: DINCH, BTHC, TOTM (TETHM) and DEHT (DOTP/DEHTP). These plasticisers can replace DEHP in virtually all instances, also in blood bags.
  • Can NICU medical products replace DEHP?
  • Two alternative approaches are available for replacing DEHP in NICU medical products: (1) replacement by DEHP-free plasticizers; and (2) replacement of PVC entirely through the use of other polymers. Both approaches seem to provide less harmful substitutes to DEHP, but support PVC-free polymers as the preferred alternative.
  • Which plasticisers are used in medical devices?
  • The four plasticisers used in medical devices as listed in the European Pharmacopeia (DINCH, BTHC, TOTM and DEHT) have been used for more than 20 years. No adverse effects have been observed.
  • When will DEHP be banned in the EU?
  • Under the EU’s chemical regulation REACH, the use of DEHP in the remaining applications will have to be terminated by 14 December 2024, or in medical devices by 1 July 2030. The plasticiser industry has invested more than €6 billion in developing safe alternatives.
  • Can a PVC plasticizer reduce DEHP leaching?
  • Although DEHP leaching can be decreased or prevented using DEHP-free plasticizers, the lifecycle hazards associated with PVC are not addressed in this method. 13 A second alternative is to replace the PVC entirely through the use of another naturally flexible polymer.

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