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FDA |
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FDA APPROVAL Before a medical device can be marketed and be used in the USA, FDA clearance required to obtain. Therefore, the three classifications will be inspected. The three classifications are as follow: Class I devices: The medical devices that are not harmful to the patient. It means that the medical devises that are the simple and their failure is not poses risk. Class II devices: Those medical devices which are more complicated and possibly are susceptible to more risk than Class I. However, are not life threatening they need to follow all specific FDA standards guidelines. Class III devices: life depending medical devises such that their failure is life threatening. [8] RPC will stand in the category of class I because there is not no direct contact with blood and its failure is not harmful. The saline is hypoallergenic and has been approved by FDA. Also, the tubing is a Synthetic Polymer (Silicone Peristaltic, hypoallergenic) its color is White Translucent and is approved by FDA. Its dynamic operating temperature is from -20°C to +80°C which in our case the range of operation is from 0°C to 37°C. It can be autoclaved at up to 135°C or sterilized by gamma radiation or ethylene glycol. Basically, it has been specified for pharmaceutical and medical use. [4,5,8] Tube is Available in Two Forms Peroxide Cured Silicone |
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