Phthalate Medical Device Labelling

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Preliminary Guidelines on Phthalates in Medical Devices

https://compliancenavigator.bsigroup.com/en/medicaldeviceblog/preliminary-guidelines-on-phthalates-in-medical-devices/

The guidelines are required to be developed by the Medical Device Regulation (MDR; EU 2017/745) in Annex I, General Safety and Performance Requirements, Section 10.4.3, Guidelines on phthalates. Thus, when made final, they are intended to …

Guidelines on phthalates in medical devices - Public Health

https://health.ec.europa.eu/other-pages/health-sc-basic-page/guidelines-phthalates-medical-devices_en

Following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) provided the final version of the …

How to Label Medical Devices that contain Phthalates.

https://elsmar.com/elsmarqualityforum/threads/how-to-label-medical-devices-that-contain-phthalates.40263/

According to new MDD 47/2007 EEc we have to label the medical device having Phthalates which are classified as carcinogenic, mutagenic and reproductive carc …

DEHP phthalates in medical devices - GOV.UK

https://www.gov.uk/government/publications/dehp-phthalates-in-medical-devices/dehp-phthalates-in-medical-devices

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 …

Device Labeling | FDA - U.S. Food and Drug Administration

https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling

Device Labeling | FDA Device Labeling Introduction to Medical Device Labeling Label vs. Labeling The U.S. Food and Drug Administration (FDA) develops …

General Device Labeling Requirements | FDA

https://www.fda.gov/medical-devices/device-labeling/general-device-labeling-requirements

General Labeling Provisions The general labeling requirements for medical devices are contained in 21 CFR Part 801. These regulations specify the minimum requirements for …

INFORMATION ON TERUMO MEDICAL DEVICES AND …

https://www.terumo-europe.com/SiteCollectionDocuments/About%20Terumo/medical-devices-containing-phthalates.pdf

Annex I, section 7.5 requires by 21 March 2010 specific labelling where phthalates are an integral part of the medical device material formulation (i.e. not including …

Symbols for Medical Devices EN 15986 phthalates - ce-test

https://www.cetest.nl/medical-symbols-font-en15986.htm

Symbols for medical devices containing phthalates. The revision of the Medical Devices Directive per 2007/47/EC brings to your device the obligation to mark your product when …

Guidance on Medical Device Patient Labeling | FDA

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-medical-device-patient-labeling

When translating the professional label into lay language, take care to ensure that it does not alter the intent of the indications, contraindications, warnings and precautions, or …

Phthalate labelling of medical devices - PubMed

https://pubmed.ncbi.nlm.nih.gov/18078175/

Phthalate labelling of medical devices Phthalate labelling of medical devices Author O Grøndahl Hansen 1 Affiliation 1 PVC Information Council, Copenhagen, Denmark. …

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