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Sterilization for Medical Devices | FDA
- https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices
- 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...
- https://www.cdc.gov/infectioncontrol/guidelines/disinfection/sterilization/index.html
- Medical devices that have contact with sterile body tissues or fluids are considered critical items. These items should be sterile when used because any microbial …
Classify Your Medical Device | FDA
- https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device
- For Class III devices, a premarket approval application (PMA) will be required unless your device is a preamendments device (on the market prior to the passage of the medical …
Medical Device Classification (FDA & EU MDR)
- https://www.simplerqms.com/medical-device-classification/
- The US FDA’s classification of a medical device is based on its risk. Low and moderate-risk devices are classified as either Class I or Class II medical devices. These …
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