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What is Material Requirements for Plastics Used in Medical Devices about?

Plastics used in medical device applications must meet stringent performance requirements through production, packaging, shipping, end use, and disposal. Many devices and device kits are sterilized before they are shipped for use. During manufacturing and during end use, they also come in contact with various chemicals, solvents, bodily fluids, skin, organs, and tissues. The materials used in such devices must be resistant to the sterilization methods, chemicals, and fluids that they encounter, be compatible with bodily fluids, skin, and tissues, and still maintain their safety, effectiveness, and functionality. Requirements for plastics used in medical devices include the following:• Chemical and lipid resistance,• Extractables and leachables characterization, • Biocompatibility and hemocompatiblity, and • Shelf life and stability. Material Characterization Plastics used in medical device applications must be fully characterized with respect to the following attributes, as described in ISO 10993-18 (see Table .10).• Composition (identity and percent of all components in the formulation, spectroscopic and/ or chromatographic analysis, and fingerprints);• Mechanical properties (tens

Author

Vinny R. Sastri

Publisher

Elsevier

Published

2014

Language

EN