醫(yī)療器械外殼清洗方法的選擇一般應(yīng)當(dāng)考慮產(chǎn)品的材料、結(jié)構(gòu)及清洗需要達(dá)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(yī)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(jié)合。這兩種清洗方法在實際生產(chǎn)中應(yīng)用很廣。手工清洗方法主要是手工持清洗工具，按預(yù)定的要求清洗產(chǎn)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(shè)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(dǎo)致清洗工藝存在一定的不可控性，因此條件允許時應(yīng)當(dāng)盡量采取自動清洗方式。手工清洗時，應(yīng)當(dāng)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(yīng)當(dāng)考慮相應(yīng)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(yīng)當(dāng)根據(jù)產(chǎn)品的生產(chǎn)工藝、預(yù)期用途等確定清洗過程所在生產(chǎn)環(huán)境，且環(huán)境級別的設(shè)臵應(yīng)當(dāng)符合法規(guī)要求具體要求。對于無菌和植入性醫(yī)療器械外殼，末道清洗過程的環(huán)境控制應(yīng)當(dāng)符合無菌和植入性醫(yī)療器械附錄的相關(guān)要求。對于產(chǎn)品非末道清洗過程（如粗洗），其所在的生產(chǎn)環(huán)境無特殊要求，可根據(jù)產(chǎn)品要求確定適宜的生產(chǎn)環(huán)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.

醫(yī)療器械外殼清洗方法的選擇相關(guān)內(nèi)容就是這樣了，您有什么疑惑或者需求就來我們這里http://www.ddpl.com.cn咨詢吧！

This is the selection of cleaning methods for medical device shells. If you have any doubts or needs, please come here http://www.ddpl.com.cn Consult!