Medical Device Sterilization Methods

Firms may elect to comply with these standards.

Medical device sterilization methods.

Choosing a sterilization method is one of the most important steps in developing a medical device. Electron beam sterilization e beam sterilization is a safe effective and efficient processing technology used to sterilize a wide variety of disposable medical devices. A list of recognized sterilization standards appears at fda s center for devices and radiological health cdrh s web site. 27 28 ethylene oxide treatment is generally carried out between 30 and 60 c 86 and 140 f with relative humidity above 30 and a gas concentration between 200.

E beam s medical sterilization methods are the most efficient and proven solutions in the industry offering many advantages over other processes such as ethylene oxide. Ethylene oxide treatment is the most common chemical sterilization method used for approximately 70 of total sterilizations and for over 50 of all disposable medical devices. At best using an insufficient or inappropriate sterilization method can prevent your medical device from getting marketing clearance from regulatory bodies like the fda. With a wealth of experience providing sterilization for medical devices steris ast has been providing a first.

However since 1950 there has been an increase in medical devices and instruments made of materials e g plastics that require low temperature sterilization. Medical devices are sterilized in a variety of ways including using moist heat steam dry heat radiation ethylene oxide gas vaporized hydrogen peroxide and other sterilization methods for. Medical devices are complex so the choice of sterilization technology must take into consideration the device s design material product packaging and final packaging. Sterilization by ionizing radiation primarily by cobalt 60 gamma rays or electron accelerators is a low temperature sterilization method that has been used for a number of medical products e g tissue for transplantation pharmaceuticals medical devices.

At worst poor sterilization can lead to transmission of infectious diseases causing patient illness and even death. Medical device as a manufacturer we understand your need to deliver trusted sterile medical devices to your customers and end users around the globe. While eto is a very effective sterilant cd has many benefits over eto for a variety of applications. However compliance to.