医疗器械外壳清洗方法的选择一般应当考虑产品的材料、结构及清洗需要达到的效果等方面。下面小编为您讲解下。

The selection of cleaning method for medical device shell should generally consider the material, structure and cleaning effect of the product. The following section explains it for you.

医疗器械外壳常见的清洗方法有手工清洗、自动化清洗，以及两种方法的结合。这两种清洗方法在实际生产中应用很广。手工清洗方法主要是手工持清洗工具，按预定的要求清洗产品。

The common cleaning methods of medical device shell include manual cleaning, automatic cleaning, and the combination of the two methods. These two cleaning methods are widely used in practical production. The manual cleaning method is mainly to hold the cleaning tools manually and clean the products according to the predetermined requirements.

常用的清洗工具一般有能喷洒清洗剂和淋洗水的喷枪，刷子、尼龙清洁块等。自动清洗方法是由自动化的专门设备按一定的程序自动完成整个清洗过程的方式。

Common cleaning tools include spray guns, brushes, nylon cleaning blocks, etc. that can spray cleaning agents and rinsing water. The automatic cleaning method is a way in which the entire cleaning process is automatically completed by the automatic special equipment according to a certain program.

常见的有超声波清洗、高压喷淋清洗等。由于手工清洗时，不同人员间存在一定的个体差异，而导致清洗工艺存在一定的不可控性，因此条件允许时应当尽量采取自动清洗方式。手工清洗时，应当评价影响清洗效果的各种因素，如果明确了可变因素，在清洗验证过程中应当考虑相应的差条件。

The common ones are ultrasonic cleaning, high-pressure spray cleaning, etc. Due to certain individual differences between different personnel during manual cleaning, the cleaning process is uncontrollable, so automatic cleaning should be adopted as far as possible when conditions permit. During manual cleaning, various factors affecting the cleaning effect shall be evaluated. If the variable factors are defined, the corresponding poor conditions shall be considered in the cleaning verification process.

此外应当根据产品的生产工艺、预期用途等确定清洗过程所在生产环境，且环境级别的设臵应当符合法规要求具体要求。对于无菌和植入性医疗器械外壳，末道清洗过程的环境控制应当符合无菌和植入性医疗器械附录的相关要求。对于产品非末道清洗过程（如粗洗），其所在的生产环境无特殊要求，可根据产品要求确定适宜的生产环境。

In addition, the production environment of the cleaning process should be determined according to the production process and intended use of the product, and the setting of the environmental level should meet the specific requirements of the regulatory requirements. For sterile and implantable medical device shells, the environmental control of the final cleaning process should meet the relevant requirements of the appendix of sterile and implantable medical devices. For the non final cleaning process (such as rough cleaning), the production environment where the product is located has no special requirements, and the appropriate production environment can be determined according to the product requirements.

医疗器械外壳清洗方法的选择相关内容就是这样了，您有什么疑惑或者需求就来我们这里http://dcjzl.com咨询吧！

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