ISO 13485 Certification

ISO (International Organization for Standardization) has developed several standards specifically aimed at ensuring the quality and safety of plastic medical components used in healthcare settings. These standards are essential to regulate the manufacturing and development processes of such components, which play a crucial role in medical devices and equipment. One of the key ISO standards in this domain is ISO 13485, which focuses on the quality management system for medical devices, including plastic components. This standard sets requirements for the entire product lifecycle, from design and development to production, installation, and servicing.

Furthermore, ISO 14644 provides guidance on cleanroom environments used in the manufacturing of medical components. As plastic medical components are often manufactured in controlled environments to prevent contamination, this standard defines cleanliness levels and monitoring procedures to maintain an aseptic manufacturing environment. Adhering to this standard helps minimize the risk of contamination and ensures the safety and quality of the plastic components used in medical devices, making them suitable for clinical applications and patient use