This standard specifies requirements and tests for plasma filters used in cardiovascular implants and extracorporeal systems. It aims to ensure the safety and efficacy of these devices by defining criteria for design, materials, manufacturing processes, labeling, and testing procedures. The document is intended for manufacturers, regulators, healthcare providers, and other stakeholders involved in the development, evaluation, and use of plasma filters in cardiovascular applications.
*** Please note: This description may not be accurate, please refer to the official documentation.