Medical Device Sterilization Requirements

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 (for ...

Sterilization | Disinfection & Sterilization Guidelines

https://www.cdc.gov/infectioncontrol/guidelines/disinfection/sterilization/index.html

Most medical and surgical devices used in healthcare facilities are made of materials that are heat stable and therefore undergo heat, primarily steam, sterilization. …

Sterilization for Medical Devices | FDA

https://cacmap.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 …

Disinfection & Sterilization Guidelines | Guidelines Library ...

https://www.cdc.gov/infectioncontrol/guidelines/disinfection/index.html

Indications for sterilization and disinfection: by ID number and category. # Recommendation Category; 3.a. Before use on each patient, sterilize critical medical and …

Sterilization Process Controls | FDA

https://www.fda.gov/sterilization-process-controls

Sterilization - Regulatory requirements and standards

https://www.bsigroup.com/en-US/medical-devices/resources/Whitepapers-and-articles/sterilization-regulatory-requirements-and-supporting-standards/

Sterile devices are free of viable microorganisms. Regulatory requirements for medical devices include particular requirements for devices supplied or intended to be used in a …

Reprocessing of Reusable Medical Devices | FDA

https://www.fda.gov/medical-devices/products-and-medical-procedures/reprocessing-reusable-medical-devices

Adequate reprocessing of reusable medical devices is vital to protecting patient safety. Inadequate cleaning between patient uses can result in the retention of …

ISO 13485:2016 – Managing the medical device …

https://advisera.com/13485academy/blog/2017/06/28/how-to-manage-the-medical-device-sterilization-process-according-to-iso-13485/

Requirements for sterilization, and how to comply. Sterilization requirements are spread throughout the whole ISO 13485:2016 standard. Let’s see a few of the most important ones. Sterile …

Gamma Sterilization of Medical Devices - Food and …

https://www.fda.gov/media/132374/download

Cosmetic vs functional requirements, e.g., discoloration or odor . Radiation vs EO sterilization process . ... ISO 11137-1 is the Standard for Radiation Sterilization of …

Ensuring Safe, Effective Medical Device Sterilization in …

https://www.fda.gov/news-events/fda-voices/preventing-medical-device-shortages-ensuring-safe-and-effective-sterilization-manufacturing

Effective sterilization processes are critical to ensuring device safety, and manufacturers depend on this process. For instance, medical devices made from certain polymers …