DEHP‐plasticised PVC: relevance to blood services*
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Aubuchon J.P., 1988, The effect of plaslticizer Di‐2‐ethylhexyl phthalate on the survival of stored RBCs., Blood, 71, 448, 10.1182/blood.V71.2.448.448
CEN (European Committee for Standardization)(2010)prEN 15986 Symbol for use in the labelling of medical devices–requirements for labelling of medical devices containing phthalates[WWW document]. URLhttps://www.cen.eu/cen/Sectors/Sectors/Healthcare/Pages/default.aspx(Accessed 15/7/10).
Eucomed(2006)Eucomed position on the use of DEHP‐plasticized PVC in medical products[WWW document]. URLhttp://www.eucomed.be/upload/pdf/tl/2006/portal/publications/position_papers/2006‐09_dehp‐pvc_in_medical_products.pdf(Accessed 15/7/10).
European Commission(1993)Official Journal of the European Union. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices[WWW document]. URLhttp://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31993L0042:EN:HTML(Accessed 15/7/10).
European Commission(1967)Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws regulations and administrative provisions relating to the classification packaging and labelling of dangerous substrates. Annex 1[WWW document]. URLhttp://www.reach‐compliance.eu/english/legislation/docs/launchers/launch‐annex‐1‐67‐548‐EEC.html(Accessed 19/7/10).
European Commission Scientific Committee on Medicinal Products and Medical Devices (SCMPMD)(2002)Opinion on Medical Devices Containing DEHP Plasticised PVC; Neonates and Other Groups Possibly at Risk from DEHP Toxicity[WWW document]. URLhttp://ec.europa.eu/health/ph_risk/committees/scmp/documents/out43_en.pdf(Accessed 15/7/10).
European Commission Scientific Committee on Toxicity Ecotoxicity and the Environment (CSTEE)(2004)Opinion on the result of a second Risk Assessment of bis(2‐ethylhexyl)phthalate(DEHP) Human Health Part[WWW document]. URLhttp://ec.europa.eu/health/ph_risk/committees/sct/documents/out214_en.pdf(Accessed 16/7/10).
European Commission(2007a)Official Journal of the European Union. Directive 2007/47/EC Of The European Parliament And Of The Council of 5 September 2007[WWW document]. URLhttp://eur‐lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:247:0021:0055:EN:PDF(Accessed 15/7/10).
European Commission Scientific Committee on Emerging and Newly‐Identified Health Risks (SCENIHR)(2007b)Preliminary report on the safety of medical devices containing DEHP‐plasticized PVC or other plasticizers on neonates and other groups possibly at risk[WWW document]. URLhttp://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_008.pdf(Accessed 15/7/10).
European Commission. European Chemicals Bureau.(2008a)EUR 23384 EN/2 European Union Risk Assessment Report bis (2‐ethylhexyl) phthalate (DEHP) Volume 80. Luxembourg: Office for Official Publications of the European Communities 2008 EUR–Scientific and Technical Research series–ISSN 1018–5593[WWW document]. URLhttp://ecb.jrc.ec.europa.eu/documents/Existing‐Chemicals/RISK_ASSESSMENT/REPORT/dehpreport042.pdf(Accessed 16/7/10).
European Commission Scientific Committee on Emerging and Newly‐Identified Health Risks (SCENIHR).(2008b)Opinion on the safety of medical devices containing DEHP‐plasticized PVC or other plasticizers on neonates and other groups possibly at risk[WWW document]. URLhttp://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_014.pdf(Accessed 15/7/10).
European Food Safety Authority, 2005, Opinion of the scientific panel on food additives, flavourings, processing aids and materials in contact with food (AFC) on a request from the commission related to bis(2‐ethylhexyl)phthalate (DEHP) for use in food contact materials. Question N° EFSA‐Q‐2003‐191., EFSA Journal, 243, 1
FDA.U.S. Food and Drug Administration (2002a)Medical devices made with polyvinylchloride (PVC) using the plasticiser di‐(2‐ethylhexyl) phthalate (DEHP). Draft guidance for industry and FDA Draft released for comment FDA Centre for Devices and Radiological Health.
FDA.U.S. Food and Drug Administration (2002b)Safety assessment of di(2‐ethylhexyl) phthalate (DEHP) released from PVC medical devices FDA Centre for Devices and Radiological Health.
Health Canada Expert Advisory Panel On DEHP In Medical Devices(2002) Final Report 2002 January 11 Health Canada. Ottawa Canada[WWW document]. URLhttp://www.hc‐sc.gc.ca/dhp‐mps/alt_formats/hpfb‐dgpsa/pdf/md‐im/sapdehp_rep_gcsdehp_rap_2002‐01‐11‐eng.pdf(Accessed 14/7/10).
Health Canada.Medical Devices Bureau Therapeutic Products Directorate Health Products and Food Branch (2002)DEHP in Medical Devices: an exposure and toxicity assessment.
Labow R.S., 1987, The effect of the plasticizer di(2‐ethylhexyl)phthalate on red cell deformability., Blood, 70, 319, 10.1182/blood.V70.1.319.319
Schilling K. Gembardt C.&Hellwig J.(2001)Di‐2‐ethylhexyl phthalate‐two generation reproduction toxicity study in Wistar rats by continuous dietary administration. Laboratory Project Identification 70R049/97139.Department of Experimental Toxicology and Ecology BASF Aktiengesellschaft 67056 Ludwigshafen. Report to the European Council for Plasticizers and Intermediates CEFIC Brussels Belgium.
Wolfe G.W.&Layton K.A.(2003)Multigeneration reproduction toxicity study in rats (unaudited draft): diethylhexylphthalate: multigenerational reproductive assessment when administered to sprague‐dawley rats in the diet. TherImmune Research Corporation (Gaithersburg Maryland) TRC Study n°7244‐200 2003[WWW document]. URLhttp://ntp.niehs.nih.gov/index.cfm?objectid=21FA3229‐F1F6‐975E‐78052E38CE3F314C(only abstract Accessed 17/7/10).