<P> 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 </P> <P> In addition, the cleanliness of re-usable devices has led to a series of standards, including: </P> <Ul> <Li> ASTM E2314: Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)" </Li> <Li> ASTM D7225: Standard Guide for Blood Cleaning Efficiency of Detergents and Washer - Disinfectors </Li> <Li> ASTM F3208: Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices </Li> </Ul> <Li> ASTM E2314: Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)" </Li>

What are class 1 and class 2 medical devices