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Bis (2-ethyhexyl) phthalate (DEHP) and Bisphenol A …
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/2-ethyhexyl-phthalate-bisphenol-questions-answers-medical-devices.html
- On September 1, 2008 Health Canada will be sending out a survey to ALL manufacturers of licensed Class II, III and IV medical devices. In this survey the manufacturer will only be asked to check a box as to whether their devices contain ≥0.1% …
Medical devices - Canada.ca
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html
- Medical devices. The term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the …
Guidance on how to complete the application for a new …
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-complete-application-new-medical-device-licence/definitions.html
- DI (2-Ethylhexyl) Phthalate (DEHP): A chemical additive that is used to make polyvinyl chloride (PVC) soft, flexible and kink-resistant. PVC plasticized with DEHP is currently …
Phthalates - Canada.ca
- https://www.canada.ca/en/health-canada/services/chemicals-product-safety/phthalates.html
- Canada took action following the 1994 assessment to limit Canadians' exposure to DEHP by: banning its use in cosmetics managing its use in medical devices regulating its use …
Guidance documents – Medical devices - Canada.ca
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents.html
- Guidance documents – Medical devices. For industry information about COVID-19, visit our COVID-19 medical devices section. Guidance documents have …
DEHP – performance measurement evaluation - Canada.ca
- https://www.canada.ca/en/health-canada/services/chemical-substances/performance-measurement-toxic-substances/dehp.html
- DEHP – performance measurement evaluation. Bis (2-ethylhexyl) phthalate. CAS Registry Number 117-81-7. DEHP was first assessed by the Government of Canada in 1994, …
Guidance on how to complete the application for a new …
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-complete-application-new-medical-device-licence.html
- Medical devices are classified into one of 4 classes. Class I represents the lowest risk and Class IV represents the highest risk. Class II, III and IV medical devices must be licenced before they may be imported …
Guidance Document: Guidance for the Labelling of …
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-labelling-medical-devices-including-vitro-diagnostic-devices-appendices.html
- Each device including a system, medical device group, medical device family, or medical device group family must have a name. The device licence is issued for …
Di(2-ethylhexyl)phthalate and Bisphenol A Testing for …
- https://www.intertek.com/green/dehp-and-bpa-testing/
- DEHP and BPA Testing for Health Canada Medical Device Licensing Intertek, a global leader in restricted materials compliance, provides di (2-ethylhexyl)phthalate (DEHP) …
DEHP In Medical Devices - B. Braun
- https://www.bbraun.com.au/en/stories/dehp-in-medical-devices.html
- DEHP in Medical Devices Diethylhexylphthalate (DEHP) 1 is a phthalate, a chemical substance that is frequently used to soften PVC (Polyvinyl Chloride) medical devices, …
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