1. Material Requirements for Plastics Used in Medical Devices
- Author
-
Vinny R. Sastri
- Subjects
Bioburden ,Medical device ,Materials science ,Biocompatibility ,Waste management ,Spin welding ,Sterilization (microbiology) ,Material requirements ,Surgical Gloves ,Shelf life ,Biomedical engineering - Abstract
Publisher Summary 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: 1. Material characterization, 2. Sterilization resistance, 3. Chemical and lipid resistance, 4. Extractables and leachables characterization, 5. Biocompatibility and hemocompatiblity, and 6. Shelf life and stability. Many devices need to be packaged and sterilized either before distribution or before use. Examples of such devices are exam and surgical gloves, clean room garments, specimen cups, wound care products, sutures, needles, syringes, catheters, drain bags, IV bags, fluid delivery systems, dialysis equipment, implants, surgical instruments, dental instruments, surgery supplies, and combination products. All materials used in such medical devices, including the plastics used in them, must be capable of being sterilized without loss of performance.
- Published
- 2022