醫療器械外殼清洗方法的選擇一般應當考慮產品的材料、結構及清洗需要達到的效果等方面。下面小編為您講解下。

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.

醫療器械外殼常見的清洗方法有手工清洗、自動化清洗，以及兩種方法的結合。這兩種清洗方法在實際生產中應用很廣。手工清洗方法主要是手工持清洗工具，按預定的要求清洗產品。

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噴灑清洗劑和淋洗水的噴槍，刷子、尼龍清潔塊等。自動清洗方法是由自動化的專門設備按一定的程序自動完成整個清洗過程的方式。

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.

常見的有超聲波清洗、高壓噴淋清洗等。由于手工清洗時，不同人員間存在一定的個體差異，而導致清洗工藝存在一定的不可控性，因此條件允許時應當盡量采取自動清洗方式。手工清洗時，應當評價影響清洗效果的各種因素，如果明確了可變因素，在清洗驗證過程中應當考慮相應的差條件。

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.

此外應當根據產品的生產工藝、預期用途等確定清洗過程所在生產環境，且環境級別的設臵應當符合法規要求具體要求。對于無菌和植入性醫療器械外殼，末道清洗過程的環境控制應當符合無菌和植入性醫療器械附錄的相關要求。對于產品非末道清洗過程（如粗洗），其所在的生產環境無特殊要求，可根據產品要求確定適宜的生產環境。

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.

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