Residual Manufacturing Materials
Contaminates on medical devices are rising concerns to manufactures as they may lead to biocompatibility failures or potentially put the patient at risk. Contaminates can be launched from a variety of different operations including the detergents and disinfectants used in the cleaning and disinfection operations and the lubricants, oils, or solvents used during the manufacturing process. Therefore, it's necessary for manufacturers to build on appropriate levels of residues on their devices based upon the intended use and patient contact condition.
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