CHEMICAL CHARACTERIZATION OF MEDICAL DEVICE

Chemical Characterization of Medical Devices

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

  MDR LABELLING REQUIREMENTS   [A]   NON-ACTIVE MEDICAL DEVICES   Information on the Label 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 registered…