in: Handbook of Polymers in Medicine, Masoud Mozafari,Narendra Pal Singh Chauhan, Editor, Woodhead Publishing Limited , Chennai, pp.703-733, 2023
Every day numerous polymeric materials are utilized all around the world. The same polymeric materials can be used as textile materials or surgical sutures. Also, it can be produced by many different manufacturers. Polymeric materials must meet relevant standards in the scope of safety and quality to be used in medical devices. For most medical devices, biocompatibility, safety, and efficacy are determined by the guidelines of the International Organization for Standardization, the US Pharmacopeial Convention, and ASTM International and Conformité Européenne (European Conformity) marking. Because there are many polymer-based materials from sutures to catheters, from bone cement to ophthalmic lenses, and from heart valves to infusion bags, it can be very compelling to define the exact standard for polymeric materials. In this chapter, we will define the regulations and standards that a polymeric material must provide to be defined as a medical device.