Medizinprodukt
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