medical dehp free Germany

  • ConvaTec Introduces DEHP-Free UnoMeter™ Safeti™ Plus Urine

    Jul 25, 2014 · Friday, July 25, 2014. Company Replacing DEHP in All Its Products. Deeside, Wales (July 25, 2014)ConvaTec, a leading global medical products and technologies company, today announced that its UnoMeter™ Safeti™ Plus portfolio of hourly diuresis systems is now free of DEHP. The company now offers its major Continence & Critical Care brands in DEHP-free design, including the Flexi-Seal


    phthalates. Many PVC medical products typically contain approximately 30% DEHP. 3. When PVC is formulated using DEHP, no bonds form between the DEHP and PVC chemicals, allowing DEHP to exist as free molecules between polymer fibers. These molecules can leave the plastic and migrate to the surrounding environment.

  • Non-DEHP PVC and Medical Devices Thought Leadership

    By Larry Wallace. The story around PVC (polyvinyl chloride) and DEHP (di-2ethylhexyl phthalate)-based PVC in medical devices has been well told. PVC has been a staple in medical products and medical devices since the second world war and today still really has no equal in its widespread use and application. Nevertheless, about thirty years ago

  • Bis(2-ethylhexyl) phthalateWikipedia

    Bis(2-ethylhexyl) phthalate (di-2-ethylhexyl phthalate, diethylhexyl phthalate, DEHP dioctyl phthalate, DOP) is an organic compound with the formula C 6 H 4 (CO 2 C 8 H 17) 2.DEHP is the most common member of the class of phthalates, which are used as plasticizers.It is the diester of phthalic acid and the branched-chain 2-ethylhexanol.This colorless viscous liquid is soluble in oil, but not


    Medical Device DEHP FREE EXTENSION SET WITH IN-LINE FILTER 1,2 MICRON30.235B. The medical device DEHP FREE EXTENSION SET WITH IN-LINE FILTER 1,2 MICRON is realized by BERTONI NELLO S.R.L. Trade name For the german version visits de.medicaldevices24

  • Must all Disposable Medical Devices be DEHP Free for MDR?

    Jun 23, 2021 · Sep 20, 2018. #1. Hi All , According to the MDR, 10.4.5 Labelling, where devices, parts thereof materials used therein as referred to in section 10.4.1 contain substances referred to in points (a) or (b) of section 10.4.1 in a concentration above 0.1% weight by weight (w/w), the presence of those substances shall be labeled on the device itself

  • The medical device company leads the way for hospitals to

    phthalate (DEHP). More studies are indicating that PVC bags with DEHP, a plastic softener that can leach from devices, are linked at certain levels to birth defects and other illnesses. The Food and Drug Administration has issued a public health notification about DEHP. Many companies now have DEHP-free lines but still offer DEHP-containing medical

  • Safety Assessment of Di(2-ethylhexyl)phthalate (DEHP

    (DEHP), a compound used as a plasticizer for polyvinyl chloride (PVC) medical devices. DEHP has been shown to produce a wide range of adverse effects in experimental animals, notably liver

  • Borla Inc. Medical Device Supplier Directory

    DEHP-free and latex-free Compliance with USP <797> and ASHP guidelines for reducing risks associated with compounded sterile preparations. Custom Solutions. Yukon Medical possesses extensive experience in designing and commercializing novel pharmaceutical devices.

  • Regulation of DEHP Health Care Without Harm

    The BfArM (Germany) on DEHP in Medical Devices. The German Federal Institute For Drugs And Medical Devices (BfArM) has been concerned about the use of DEHP in medical devices for years, visiting the issue twice. In August 2001, BfArM convened an expert group discussion on the issue of DEHP in medical devices.

  • IV Extension Set, Mini-Bore, Slide Clamp, Luer-Lock, Latex

    IV Set, Extension, Mini-Bore, 7'', Luer-Lock, Slide Clamp, Non-DEHP, Latex-free, 50/case Products specifications Medical License Required

  • ENDO SMARTCAP™ TubingCantel Medical

    ENDO SMARTCAP™ Tubing is a 24-hour use water bottle adapter. ENDO SMARTCAP™ Tubing serves as an alternative to the reusable water bottle in GI Endoscopy. Furthermore, the ENDO SMARTCAP™ Tubing design minimizes infection control risks, which are associated with manual cleaning and sterilization.

  • Medical devicesBerner Safety

    Medical face masks. Tested filter performance medical face masks to protect against infectious germs and to reduce the risk of infection. Latex free and type II masks according to EN 14683.

  • B BraunDistributed by CP Medical

    B. Braun Vet Care Germanyfor veterinarians, for veterinary assistants and for the animal. The health as well as the satisfaction of pet owners, of veterinarians and of the staff in the animal clinic is very important for us. B. Braun and Aesculap, based in Germany, have been a synonym for high-quality medical and pharmaceutical products

  • DEHP free I.V Infusion Set

    • DEHP Free. • For gravity feed only. • Strong, sharp spike for easy penetration. • Transparent drip chamber for easy monitoring of flow rate and priming. • 15 micron fluid filter inside drip chamber for filtration of foreign particles in the fluid. • Kink resistant PVC Tube for uniform flow rate.

  • ConvaTec goes DEHP Free

    ConvaTec Goes DEHP Free. Polyvinyl chloride (PVC) plastic is used in medical devices for critical applications such as enternal feeding, wound drainage and airway ventilation. However, it is hard and brittle at room temperature. To make it flexible, it must be softened by

  • Medical Device MS10-DEHP FREEZ072810F

    The medical device MS10-DEHP FREE is realized by FRESENIUS KABI AG. Trade name. MS10-DEHP FREE. Product Code. Z072810F. Manufacturer of the medical device. FRESENIUS KABI AG. Vat Number. .

  • ICU Med Broadens Non-PVC/Non-DEHP IV Solutions Portfolio

    Aug 11, 2020 · San Clemente, Calif. August 11, 2020ICU Medical, Inc. (NASDAQ ICUI) today announced that it has entered into a long-term agreement with Grifols to distribute a full line of non-PVC/non-DEHP IV containers for 0.9% Sodium Chloride Injection, USP to customers in the United States. This new agreement will expand ICU Medical’s non-PVC/non-DEHP offering to include 50 mL


    exposure to DEHP has become available as well as data on toxicity obtained in laboratory animal and human studies. Also for DEHP a so called tolerable daily intake (TDI) was calculated in recent risk evaluations. Therefore an overview is presented on the safety of DEHP in medical devices.

  • DEHP phthalates in medical devicesGOV.UK

    Jan 26, 2021 · Phthalates are chemicals added to polyvinyl chloride (PVC) plastic to make it softer and more flexible.Di (2-ethylhexyl) phthalate (DEHP) is the type used the most in medical devices such as


    German Federal Institute for Drugs and Medical Devices (BfArM 2004), have also recommended the use of alternatives for vulnerable patient groups and encouraged manufacturers to develop new and safer DEHP-free alternatives 4. Unfortunately, in the remaining EU member states, there are no

  • Non-PVC, Non-DEHP IV Solutions ICU Medical

    ICU Medical offers VisIV in non-PVC/non-DEHP, non-latex IV container in 0.9% Sodium Chloride Injection, USP and 5% Dextrose Injection USP, available in 50 mL, 100 mL, and 250 mL and made for drug compatibility. VisIV features large print for readability, a clear container for easy inspection, and sterile ports that eliminate the need for

  • What is the best alternative to DEHP for medical-grade PVC

    Apr 22, 2016 · While phthalate esters such as DEHP are the most widely used plasticizers for flexible PVC medical compounds and have been for 50 years, issues concerning their possible effects on human health have caused some device manufacturers to consider compounds containing alternative plasticizers. Sometimes the pressure to do so is considerable.


    STOPCOCK IV 3 GANG, 4-WAY W/BASEPLATE DEHP-FREE LATEX-FREE, 50/CS. Part Number ICU Medical B4105. SKU Number CIA. Sell Unit CASE. Ships Within Special Order. List Price $161.00. Qty Enter a valid quantity. Add to Cart.

  • DEHPB. Braun Medical Inc.

    Areas of Use of DEHP DEHP is not known to occur naturally. The worldwide production of DEHP has been increasing over the past several decades. Around 97% of DEHP is used as a plasticizer in polymers, mainly PVC. Exposure to DEHP varies widely, and is dependent on Medical procedure Lipophilicity, or ability of a chemical compound to dissolve in lipids, of the fluid that comes into contact

  • Exposure of patients to di(2-ethylhexy)phthalate (DEHP

    Jan 30, 2020 · The plasticizer di(2-ethylhexyl)phthalate (DEHP) is often used for PVC medical devices, that are also largely used for intensive care medical treatments, like extracorporeal membrane oxygenation (ECMO) therapy. Due to the toxicological potential of DEHP, the inner exposure of patients with this plasticizer is a strong matter of concern as many studies have shown a high leaching