Mould Design Stage

Medical injection moulding places significantly stricter demands on material, process, and documentation than industrial injection moulding. Deviations that are acceptable in other sectors can lead to product recalls or patient risk in medical applications. Medical injection moulding requires biocompatible materials that comply with standards such as ISO 10993 and, in many cases, USP Class VI. The manufacturing process must be traceable, validated, and documented in accordance with ISO 13485, the quality management standard for medical devices. Dimensional accuracy, surface quality, and material selection are directly determined by the end application: diagnostic, surgical, or implantable. What distinguishes medical injection moulding from standard injection moulding? Medical injection moulding differs from standard injection moulding in the regulatory requirements, material requirements, and quality assurance processes applied to each part produced. - Biocompatibility the material must not cause a harmful reaction on contact with body tissues or fluids - Sterilisation resistance the component must withstand the applied sterilisation method (ETO, gamma radiation, steam sterilisation or VHP) - Traceability each batch must be traceable to the material used, the mould, the machine and the process parameters - Validation the production process is validated via an IQ/OQ/PQ (Installation, Operational and Performance Qualification) process before series production begins - Documentation fully documented production records are required for regulatory audits and product dossiers These requirements apply regardless of whether the component is a single-use disposable product or a reusable diagnostic instrument. Welke materialen worden gebruikt bij medisch spuitgieten? Material selection in medical injection moulding is determined by the application, type of bodily contact, and sterilisation method...