CHEMICAL CHARACTERIZATION OF MEDICAL DEVICE

Chemical Characterization of Medical Devices

CE Marking

EN ISO 10993-18 ( CHEMICAL CHARACTERIZATION OF MEDICAL DEVICE )     Chemical characterization is a crucial step in evaluating the biocompatibility of a medical device. It is done to identify and characterize the chemical constituents (extractable and leachable) which could disclose biological risks to patients and medical practitioners. Extractables are substances that can be…

medical device labelling

Medical Device Labelling Requirements

CE Marking

[A]  Non-Active Medical Device Labelling  Information on the EU MDR Medical Device Labelling Requirements  Name or trade name of the device. Necessary details for a user to identify the device, the contents of the packaging, and the intended purpose of the device. The name, registered trade name or registered trademark, and the address of its…