medical dehp free Belgium

  • ICU Medical

    shop icumed Number 798361 EDI Number 798361 † See footnotes below regarding Latex and Preservative information Case Information Unit of Sale NDC

  • Apex Flexible PVC for MedicalTeknor Apex

    Medical device manufacturers around the globe turn to Teknor Apex year after year for product innovations reliability and quality Our Medical Grade PVC Compounds lead the industry on all fronts Non DEHP plasticizer options color hold after Gamma and E Beam sterilization and ultra clear tubing and parts that result from decades of formulation and manufacturing expertise

  • Belgian study links DEHP plasticizer in medical devices to

    DEHP is typically used in IV bags and tubing catheters feeding bags and respiratory tubing among other medical devices While alternatives to DEHP have existed for some time and new plasticizers have been developed BASF s DINCH for example industry organizations note that none of them have been tested as extensively as DEHP which

  • 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

  • Regulation and product standards for medical applications

    Regulation and product standards for medical applications In Europe the import and manufacture of medical devices is regulated by the European Union s Medical Devices Regulation 2017/745 This Regulation is in place to ensure that medical devices sold in Europe will not be harmful or pose any health


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  • 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

  • IV Sets ICU Medical

    Get access to Clave IV connector technology in an extensive portfolio of procedure ready sets ICU Medical invented the first safety IV connector and has maintained technology leadership with the clinically preferred 1 Clave design available in an extensive portfolio of infusion therapy sets Whether it s a general infusion anesthesia or specialty sets for the NICU and PICU we can help

  • Medical devicesPVCMed Alliance

    DEHP free plasticisers available for medical applications In order to make the PVC material soft and flexible plasticisers US plasticizers are added As all medical devices PVC medical equipment with any plasticiser is subject to stringent pre and post market control and evaluation procedures to ensure safety and performance

  • Additives in medical applicationsECVM

    When the revision of the Medical Device Directive MDD 1993/42/EEC took place in 2007 DEHP was also discussed in the European Parliament As a result of input from stakeholders representatives of the European Commission the EU Council of Ministers and the European Parliament reached an agreement on DEHP on 6 March 2007

  • Bivona Inner Cannula Smiths Medical

    The Portex Bivona inner cannula system combines the benefits of using an adult Bivona silicone tracheostomy tube with an inner cannula that maintains the integrity of the tubes flexibility Reduces the risk of incorrect use with the corresponding tracheostomy tube size clearly embossed on the shaft of the inner cannula allowing you to select the correct size for use

  • TekniFlex MED Tekniplex

    It is generally accepted that a film used for the containment of medical fluids needs to present highly transparent in order to allow visual inspection of their content The transparency requirement is very important as medical fluids for intravenous application need to be absolutely clear and particle free and visual inspection will allow to determine whether or not contamination or undesired

  • Medical Tubing and Compounds Tekniplex

    Medical Tubing and Medical Grade PVC Compounds Most of our tubing is flexible monolayer PVC tubing for large volume industries where certified high quality consistancy short lead times and high service level are important Some of you special applications may require one of following specialty tubes PVC anti kinking tubing

  • Experimental study on infusion devices containing

    According to the results of this study only two medical devices out of the nine DEHP free tested are devoid of DEHP One medical device showed DEHP concentrations higher than 0 1 in plastic mass DEHP traces less than the quantification threshold were found in the drip chambers of B Braun Doran and Sendal infusion sets

  • Colorite Tekniplex

    Colorite For over 50 years Colorite is a leader in developing and manufacturing plastic compounds for the medical device industry Our division headquarters is located in Ridgefield NJ with state of the art medical grade facilities in Ridgefield/USA Sparks/USA and Belfast N Ireland With these 3 medical compounding plants Colorite is

  • 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

  • Update on the use of the plasticizer DEHP in medical

    Update on the use of the plasticizer DEHP in medical devices 04/08/2015 On 17 July 2015 the Council and the European Parliament published a latest version of their Proposal for a Regulation on medical devices and amending Directive 2001/83/EC Regulation EC No 178/2002 and Regulation EC No 1223/2009 In this context it is important for the industry to be aware of the ongoing

  • 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

  • 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

  • PVC Remains Material of Choice for Life Saving Medical

    A notable exception is blood bags where more R D is needed to replace DEHP In Europe some uncertainties remain on how the blood bags will be classified in the EU Medical Device Regulation to be applied on May 26 2021 which raises some doubts on how the DEHP free blood bags will have to be certified by the notified bodies

  • 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


    2 PRODUCT COMPLIANCE CE marked Class I Medical Devices Rule 1 MDD 93/42/EEC UMDNS 13942 Complies with the following norms directives and regulations ― ISO 7886 1 ― ISO ― EN ISO ― EN ISO ― EN ISO ― EN ISO ― EN ISO ― EN ISO 13485

  • Symbol glossary definitionsAdvancing the World of Health

    Indicates a medical device that contains biological tissue cells or their derivatives of human origin ISO/DIS 15223 1 2020 E DRAFT Reference no 5 4 10 ISO Medical Devices Symbols to be used with medical device labels labeling and information to be supplied Part 1 General requirements

  • Phthalate and alternative plasticizers in indwelling

    DEHP is not chemically bound to plastics and can thus leach from the medical devices during the use In critically ill neonates the urinary levels of DEHP metabolites have been correlated with the number of DEHP containing medical devices and even exceeded the average daily adult exposure by 1–2 orders of magnitude 2 3

  • 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

  • Shinva Ande Healthcare Apparatus Co Ltd Medical

    01 Electromedical equipment Medical Technology 01 04 Intense medicine anesthesiology respiration 01 04 01 Anaesthetic equipment 01 04 01 05 Infusions sets MEDICA 2017 Infusions sets Infusion Set with Burette Opaque Infusion Set with Precise Regulator PVC PVC DEHP FREE Extension Tubes 3 Products ad contact information Company

  • 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

  • Medical Dehp Free Types Of Infusion Set/iv Drip Set/iv

    Medical Dehp Free Types Of Infusion Set/iv Drip Set/iv Pump Set Find Complete Details about Medical Dehp Free Types Of Infusion Set/iv Drip Set/iv Pump Set Iv Pump Set Iv Drip Set Infusion Set Iv Pump Set from Other Medical Comsumables Supplier or Manufacturer Nanjing Hoshin Medical

  • IV Sets Arcomed AGOmnia Health

    IV Sets arcomed offers a complete portfolio of Volumed DEHP free PVC and silicon infusion sets for the administration of medication via gravity and infusion pump including high precision DEHP free PVC tubing TOTM or silicon to ensure high performance in all applications All sets include vented drip chambers with 15μm fluid filter Luer

  • Phthalate freeIntersurgical

    The availability of safer alternatives to PVC products means the prudent course of action for NICU s could be to introduce DEHP/PVC free products Plasma phthalate levels in pubertal gynecomastia Use of di 2 ethylhexyl phthalate containing medical products and urinary levels of mono 2 ethylhexyl phthalate in neonatal intensive care unit

  • 2017 regulatory update on DEHP in medical devices

    2017 regulatory update on DEHP in medical devices 29/06/2017 A lot of things are happening in the world of plasticisers and medical devices In fact it seems as if 2017 will be a decisive year for the use of DEHP in PVC based medical devices In an interview filmed at PVC 2017 in Brighton Vice President of Regulatory Affairs/Advocacy at


    medical equipment DEHP is the most common phthalate found in medical devices In the European phthalate market DiNP and DiDP/DPHP have substituted DEHP as the most common phthalate However it is not clear whether this overall trend is mirrored in the medical sector Besides being classified as a reproductive toxicant DEHP

  • DEHP in Medical Devices Risks Still Unclear After Decades

    DEHP in medical devices and published so called opin ions on the matter in 2002 2008 and 2014 the latter a Belgium Italy 2x Spain Austria France Germany Greece and Slovenia The members share a background in European public research institutions with 10 being employed at univer

  • Dialysis solution for CRRTnikkisomedical

    Nikkiso Belgium bvba Industriepark 6 3300 Tienen Belgium Dialysis solution for CRRT CRRT Continuous Renal Replacement Therapy PVC Polyvinyl chloride DEHP Diethylhexyl phthalate Individualised prescribing Three ready to mix formulations offering multiple potassium concentrations better matching your patient prescription 100

  • REACH Committee approves use of DEHP in recycled PVC

    On 20 April the REACH Registration Evaluation Authorisation and Restriction of ChemicalsEU s chemicals legislation Committee supported the Commissions proposal to approve the request made by three companies Vinyloop Ferrara Stena Recycling and Plastic Planet to use DEHP in a wide range of products produced from recycled PVC

  • France s Important Move Towards Phasing Out Phthalates in

    Brussels Today France passed a law that for the first time bans the use of tubes containing di 2 ethylhexyl phthalate DEHP in paediatrics neonatology and maternity wards in hospitals Health Care Without Harm Europe now calls on all European Member States to follow the example of France and move towards a phase out of phthalates in medical devices as swiftly as possible