The International Organization for Standardization (ISO) presents widely adopted medical device guidelines that are aimed with a keen focus towards risk management. Biocompatibility testing for these devices and device components is addressed by ISO standard 10993. RESINATE 2017
Well-defined material characterization is a fundamental requirement in biocompatibility assessment. This evaluation consists of chemical, mechanical, and thermal characterization elements. Material characterization is of particular importance for plastics because nominally similar grades of plastics can vary significantly in their material and chemical attributes. Plasticizers, stabilizers, and fillers added to plastics during manufacturing can affect their biocompatibility. Leaching studies must be performed on plastics with additives such as these to ensure that leachates from the plastics are non-toxic. The amount and type of additive will also affect the biocompatibility of the final plastic product. ©2010, ©2017, Zeus Industrial Products
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