Medical Device Sterility Requirements

Sterilization for Medical Devices | FDA

https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices

Sterilization for Medical Devices | FDA Sterilization for Medical Devices Medical devices are sterilized in a variety of ways including using moist heat (steam), dry heat,...

Sterilization | Disinfection & Sterilization Guidelines

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

However, since 1950, there has been an increase in medical devices and instruments made of materials (e.g., plastics) that require low-temperature sterilization. …

Sterilization Process Controls | FDA

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

Sterility and Infection Control Program: Research on …

https://www.fda.gov/medical-devices/medical-device-regulatory-science-research-programs-conducted-osel/sterility-and-infection-control-program-research-medical-devices

Sterility and Infection Control Program: Research on Medical Devices The Sterility and Infection Control Program in the FDA’s Center for Devices and Radiological …

Sterilization - Regulatory requirements and standards

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

Regulatory requirements and supporting standards Sterile devices are free of viable microorganisms. Regulatory requirements for medical devices include particular …

Reprocessing of Reusable Medical Devices | FDA

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

Reusable medical devices are devices that health care providers can reuse to diagnose and treat multiple patients. Examples of reusable medical devices include …

Sterility Testing of Medical Devices: An Overview

https://cdnmedia.eurofins.com/corporate-eurofins/media/12154151/9433_sterlity-test-medical-devices_web-ready.pdf

devices is required during the sterilization validation process and routine release testing. According to ISO 11737-2 (Sterilization of medical devices -- Microbiological methods -- …

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/

Particular requirements for sterile medical devices (Clause 7.5.5) sets two direct requirements: Records of process parameters of sterilization of each batch – Sterilization process parameters need to …

Designating of medical devices as sterile and the MDR

https://compliancenavigator.bsigroup.com/en/medicaldeviceblog/designating-of-medical-devices-as-sterile-and-the-mdr/

Sterile devices are free of viable microorganisms. The EN 556 series of standards defines requirements for designating devices as sterile. Parts 1 and 2 of EN …

ISO 11607 : Requirements for Sterile Medical Device …

https://www.qualitymeddev.com/2021/02/18/iso-11607/

General Requirements according to ISO 11607 Section 4 of ISO 11607 explains the general requirements associated to sterile packaging for medical devices. It complies of different subsections and …