Cleaning of medical devices is a critical step for evaluating biocompatibility and controlling the microbiological load for sterilization, 紧密配合ISO 10993-1要求. 患者安全不仅与正在使用的特定材料有关, but also an understanding of the contaminants or residuals that can be introduced or observed during the manufacturing and handling processes.
The cleaning methods used need to be evaluated to ensure they don’t negatively impact either the biocompatibility or functional performance of the device. 另外, cleaning validations ensure that the cleaning process removes sufficient levels of contaminants without introducing new contaminants. Cleanliness evaluations of devices can range from testing water purity used in manufacturing processes on a quarterly or monthly basis, 确认清洗剂残留物已被清除, 以及减轻环境风险. 其他领域包括清洁过程中使用的材料的风险评估, 在整个生产过程中识别潜在污染物, 并确保灭菌前的生物负荷水平足够低.
器械清洁度评估并不局限于生产过程. 可重复使用的医疗设备 undergo cleaning and disinfection, or sterilization, reprocessing procedures between patients. These reprocessing instructions for use (IFU) must also be validated to prevent any cross-patient contamination in healthcare settings.
总的来说，向用户提供清洁设备是制造商的责任. The objective of the cleaning validation is to determine the effectiveness of the cleaning processes to remove physical, 化学, 微生物污染物或残留物低于规定水平. This can be handled with process cleaning steps designed to remove any contamination from the previous step, 在零件分发之前进行最后的清洗. ISO 19227 is a guidance often used to evaluate orthopedic implants cleanliness and includes the methods listed below. 还概述了其他相关方法.
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可重复使用医疗器械后处理验证和测试
Every Reusable Medical Device must be reprocessed before reuse to minimize risk of contamination; this includes cleaning and either sterilization or disinfection.