Evaluation of Medical Device Packaging Materials EN 868 Packaging materials and systems for medical devices to be sterilized, General requirements and test methods ISO 11607 Packaging for terminally sterilized medical devices Package testing is part of a quality management system including verification and validation. It is important to document and ensure that packages meet regulations and end-use requirements. Manufacturing processes must be controlled and validated to ensure consistent performance. EN ISO 15223-1 defines symbols that can be used to convey important information on packaging and labeling. Biocompatibility standards ISO 10993 - Biological Evaluation of Medical Devices Cleanliness standards Medical device cleanliness has come under greater scrutiny since 2000, when Sulzer Orthopedics recalled several thousand metal hip implants that contained a manufacturing residue. Based on this event, ASTM established a new task group (F04.15.17) for established test methods, guidance documents, and other standards to address cleanliness of medical devices. This task group has issued two standards for permanent implants to date: 1. ASTM F2459: Standard test method for extracting residue from metallic medical components and quantifying via gravimetric analysis 2. ASTM F2847: Standard Practice for Reporting and Assessment of Residues on Single Use Implants 3. ASTM F3172: Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices In addition, the cleanliness of re-usable devices has led to a series of standards, including: ASTM E2314: Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)" ASTM D7225: Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors ASTM F3208: Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices The ASTM F04.15.17 task group is working on several new standards that involve designing implants for cleaning, selection and testing of brushes for cleaning reusable devices, and cleaning assessment of medical devices made by additive manufacturing. Additionally, the FDA is establishing new guidelines for reprocessing reusable medical devices, such as orthoscopic shavers, endoscopes, and suction tubes. New research was published in ACS Applied Interfaces and Material to keep Medical Tools pathogen free. Safety standards Design, prototyping, and product development Medical device manufacturing requires a level of process control according to the classification of the device. Higher risk; more controls. When in the initial R&D phase, manufacturers are now beginning to design for manufacturability. This means products can be more precision-engineered to for production to