Intertronics Publishes Medical Adhesive Guide for Safer Devices
Intertronics has published a white paper titled 'What is a medical adhesive? Key properties, use cases, and regulatory considerations'. This guide explores the crucial role of medical adhesives in device performance and safety, with an estimated two million different kinds of medical devices manufactured annually.
The white paper delves into six key characteristics that determine adhesive suitability for medical devices. These include adhesion, biocompatibility, sterilisation, compliance, patient contact duration, and process validation and QA. Medical adhesives must provide strong, durable bonds across diverse materials and meet stringent regulatory requirements.
The white paper stresses the importance of ISO 10993 biocompatibility testing and compatibility with sterilisation methods in medical adhesive selection. Careful consideration of these factors can accelerate approval timelines, reduce the risk of revalidation, and deliver safer, more effective medical devices. The white paper focuses on adhesives used for device assembly, not those used therapeutically or to secure devices to a patient's skin.
Intertronics' white paper serves as a comprehensive guide for medical device manufacturers, highlighting the significance of adhesive selection in patient safety and regulatory approval. By understanding and addressing the six key characteristics, manufacturers can enhance device performance and accelerate the approval process.
