medical dehp free Switzerland

  • Whitepaper HexamollDINCH Medical EUBASF

    DEHP is classified for reproductive toxicity 1B may damage fertility and may cause harm to the unborn child H360 FD 2 Inclusion of DEHP on SVHC candidate list concerning human health in October 2008 REACH Annex XIV based on toxicity to reproduction 57c but exemption for medical devices regarding human health per REACH Art 2 6 c

  • Infusion SetsSS MF Low Sorbing Low Sorb CV SS Health

    Infusion SetsSS MF Low Sorbing Low Sorb CV SS CV SS V/NV DP V/NV CV SS DEHP Free V/NV CKV SMS DP V/NV CKV SS DP Blood SetNV SmartSite Needle Free Valve Port Filter Report a Concern

  • DI 2 ETHYLHEXYL PHTHALATEWorld Health Organization

    Medical devices comprise approximately 25 of total manufacturing use of DEHP in the USA Medical devices that contain DEHP include PVC sheet materials such as intravenous bags and tubing used in a variety of medical applications Toxics Use Reduction Institute 2005 1 3 Occurrence Concern regarding exposure to DEHP rose to prominence when


    DEHP le ached out from medical apparatus depends United States Germany Switzerland Austria widely use Diisononyl and 5 free plasticizer PAE s were done by a researcher using GC

  • Ambulatory and Syringe InfusionSmiths Medical

    Our intravenous I V infusion disposable systems including ambulatory infusion pumps and syringe infusion pumps are available in lipid resistant non DEHP formulation latex free and needle free

  • Prenatal Exposure to DEHP Affects Spermatogenesis and

    Prenatal DEHP exposure significantly decreased spermatogenesis in C57BL/6J fold change = 0 6 p value = 8 7 10 4 but not in FVB/N fold change = 1 p value = 0 9 The number of differentially methylated regions DMRs by DEHP exposure across the entire genome showed increased hyper and decreased hypo methylation in C57BL/6J compared to FVB/N

  • Non‐phthalate plasticizer DEHT preserves adequate blood

    The lack of an acceptable plasticizer substitute for RBCs has slowed down the conversion process considerably but recently the demand became urgently motivated due to the updated European Commission regulation EC 2017/745 allowing a maximum concentration of 0 1 weight/weight of DEHP in medical devices Though exceptions are possible

  • EUA New RoHS Exemption for DEHP in Certain Rubber

    DEHP is added to rubber material as plasticizer in order to provide flexibility The rubber components are used as flexible connections between parts of engine systems and assure prevention of leakage sealing of engine parts and protection from vibration or dirt and fluids over the lifetime of the engines Currently there are no DEHP free alternatives available on the market which would

  • Home hemodialysisFresenius Medical Care

    The complete home hemodialysis solution smart bag With the Fresenius Medical Care home hemodialysis portfolio the patient is in our focus Bloodlines Easy and intuitive set up Use of plasticizer with high hemo compatibility and low cytotoxic reaction DEHP free Therapy Data Management System

  • Top 5 Things to Know About DEHPTeknor Apex

    For better or worse broad movements to eliminate DEHP and phthalates from medical devices and other products as well have gained such momentum that many in the medical industry are anticipating the day when they are no longer able to manufacture products that contain any of these substances Understanding the nuances and trade o s of the chemistries and compounds under fire is

  • List of devices made by the manufacturer Medical Devices

    In this list are all medical devices registered by the ministry of health that are produced by the manufacturer CAREFUSION SWITZERLAND 317 SÀRL Name CAREFUSION SWITZERLAND 317 SÀRL Number of products 491 DEHP FREE INFUSION SET ADAPTER FOR SYRINGE INFUSION SET ANTI SIPHON VALVE

  • 5 things to know about getting DEHP out of medical devices

    In a comprehensive European study DEHP is reported to have a no observable adverse effect level NOAEL of 4 8mg per kilogram of body weight while TOTM has a NOAEL of 100mg By comparison DOTP is listed at 500mg to 700mg making it 100x to 140x safer than DEHP for rodents and 5x to 7x safer than TOTM The same study listed NOAELs for acetyl


    INFUSION SET DEHP FREE Product Code EV Manufacturer of the medical device CAREFUSION SWITZERLAND 317 SÀRL Category Name INFUSION CONTROLLERS FOR PUMP Category Code A Sign repertoire Not Registered Group of similar Medical devices 0 Medical device reference 0 Type Medical Device Class Progressive number assigned

  • Europe Four Phthalates added to RoHS 2 List of Restricted

    On 4 June 2015 Directive EU 2015/863 1 was published in the Official Journal of the European Union adding four phthalates DEHP DBP BBP and DIBP to the list of restricted substances in Annex II of the RoHS 2 Directive 2011/65/EU The list now contains a total of 10 substances 4 heavy metals 2 flame retardants and 4 phthalates

  • Range of Multi Lumen Extension Tubes Neotec Medical

    Compatible with all standard IV sets IV catheters using luer lock connections Use of best quality components conforming to international standards Custom configurations available upon request

  • DEHP Plasticizer Market Report Global Forecast To 2028

    Global DEHP Plasticizer Market by Type General Grade DEHP Electrical Grade DEHP Food and Medical DEHP By Application Flooring Wall Coverings Film Sheet Wire Cable Consumer Goods Coated Fabric Others And By Region North America Latin America Europe Asia Pacific and Middle East Africa Forecast To 2028

  • DEHP ExposureB Braun

    Diethylhexylphthalate DEHP is a phthalate a chemical substance that is frequently used to soften PVC Polyvinyl Chloride medical devices such as blood bags tubing catheters and disposable gloves to make materials more pliable and comfortable to use The increasing knowledge of the effects of phthalate exposure which can be teratogenic carcinogenic or induce reproductive toxicity has

  • Healthcare Free Full Text Phthalates and Their Impacts

    In Europe PVC free medical and DEHP free devices are available by using polyethylene polypropylene polyurethane and other polyolefins silicone ethylene vinyl acetate and multi layerlaminate plastics as alternatives The alternative softeners are citrates benzoates trimellitates and adipates with much lower toxic levels than DEHP

  • Spiral Extesion tube Neotec Medical

    DEHP Free PVC Tubing Suitable for Syringe Pump/Infusion Pump Male or Male Male Type Lengths available 10 cm500 cm

  • The Long Goodbye to DEHP plasticized PVC mddionline

    The Long Goodbye to DEHP plasticized PVC While DEHP is still common in a range of medical devices available alternatives are enabling manufacturers to shift to the use of less fraught materials The idea of scrapping the use of polyvinylchloride PVC materials containing di 2 ethylhexyl phthalate DEHP plasticizers is not new

  • 3M Bair Hugger 241 Fluid Warming Set DEHP Free

    The Bair Hugger 241 fluid warming set enables you to use two warming modalities with one piece of equipmentthe Bair Hugger warming unit Just slide the 241 set into a Bair Hugger warming unit hose and you instantly add fluid warming to the warming protocol

  • EU REACH Annex XVII Amendment of phthalate restriction

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

  • An Overview of DEHP in Medical Devices HCL Technologies

    The Non DEHP in Medical Devices white paper briefs the usage of DEHP as a plasticizer in PVC made medical equipment along with its composition types and application Furthermore this paper elucidates the adverse effects of Non DEHP to environment users and the medical industries challenges to cope up with regulatory bodies across

  • Prenatal Exposure to DEHP Affects Spermatogenesis and

    Di 2 ethylhexyl phtalate DEHP is a plasticizer with endocrine disrupting properties found ubiquitously in the environment and altering reproduction in rodents Here we investigated the impact of prenatal exposure to DEHP on spermatogenesis and DNA sperm methylation in two distinct selected and

  • EU Proposes to Expand Restriction of Phthalates under

    Medical devices Electrical and electronic equipment EEE Immediate packaging materials for medicinal products It is important to note that DEHP DBP BBP and DIBP are regulated under Directive EU 2015/863 a piece of legislation that amended the RoHS Recast Directive on EEEs

  • Global DEHP Plasticizer Market Growth Fior

    This study considers the DEHP Plasticizer value and volume generated from the sales of the following segments Segmentation by product type breakdown data from 2014 to 2019 in Section 2 3 and forecast to 2024 in section 11 7 General Grade DEHP Electrical Grade DEHP Food and Medical DEHP Segmentation by application breakdown data from

  • Webinar recording Tackling harmful chemicals in medical

    Plastic medical equipment and devices can however be a significant source of exposure to harmful endocrine disrupting chemicals EDCs including phthalates such as DEHP Phthalates are often used to make polyvinyl chloride PVC flexible but these chemicals can harm patients not only causing infertility issues but also undermining the

  • Large BoreHI FLO Stopcocks Infusion Smiths Medical

    Large BoreHI FLO Stopcocks Smiths Medical has one of the widest selections of stopcocks available in the marketplace Our stopcocks are a leading choice of anesthesiologists and critical care nurses worldwide Smiths Medical stopcocks are available in 1 way 3 way and 4 way configurations for added convenience and versatility

  • Phthalate Regulations in the European Union An Overview

    DEHP RoHS Directive The RoHS Directive restricts the use of certain heavy metals and phthalates that are deemed dangerous in order to protect the health of the users and avoid environmental pollution Components of electronics products like plastic enclosures USB cables power cords wires and connectors often contain phthalates as

  • CRRT fluidsFresenius Medical Care

    PVC latex and DEHP free environmentally friendly thanks to the use of Biofine foil Suitable for all common CRRT devices thanks to bag eyelets connectors and bag design Low risk of contamination easy to handle thanks to the blue HF connector CRRT appropriate hemofiltration solution thanks to an optimized composition

  • ISOISO 2002Biological evaluation of medical

    ISO 2002 specifies the determination of allowable limits for substances leachable from medical devices It is intended for use in deriving standards and estimating appropriate limits where standards do not exist It describes a systematic process through which identified risks arising from toxicologically hazardous substances present

  • Phthalates Smiths Medical

    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 requires the device manufacturer to now label products that incorporate phthalates and where

  • 5 things to know about getting DEHP out of medical devices

    Phthalate esters such as diethylhexl phthalate DEHP are the most widely used plasticizers for flexible poly vinyl chloride PVC medical compounds and have been for 50 years but issues concerning their possible effects on human health have caused some device manufacturers to consider compounds containing alternative plasticizers

  • EUDraft Amendment on RoHS Exemption Regarding the

    This draft Commission Delegated Directive amends Annex IV to Directive 2011/65/EU RoHS 2 Directive regarding an exemption for the use of bis 2 ethylhexyl phthalate DEHP in ion selective electrodes for analyzing human body fluids and/or in dialysate fluids The Commission received a request for a new exemption in Annex IV in July 2018 to allow the placing on the market of medical

  • CRRT fluidsFresenius Medical Care

    PVC latex and DEHP free environmentally friendly thanks to the use of Biofine foil Suitable for all common CRRT devices thanks to bag eyelets connectors and bag design Low risk of contamination easy to handle thanks to the blue HF connector CRRT appropriate hemofiltration solution thanks to an optimized composition

  • Accessing the Market European Union Phthalate SGS

    Accessing the Market European Union Phthalate Regulations Phthalates are a ubiquitous family of chemicals found in a diverse range of products Studies now show they can have adverse impacts on human health leading to the European Union EU introducing legislative measures to restrict their use Manufacturers and suppliers must understand