Sterile Medical Device 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...

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. …

Temperature and Humidity Requirements – Guidance for …

https://www.jointcommission.org/standards/standard-faqs/ambulatory/infection-prevention-and-control-ic/000001275/

ASHRAE Standard 170- 2008 Table 7.1 ventilation requirements for sterile storage in CENTRAL MEDICAL AND SURGICAL SUPPLY areas includes the following: …

Quality System Regulation Labeling Requirements | FDA

https://www.fda.gov/medical-devices/device-labeling/quality-system-regulation-labeling-requirements

ISO 11607 : Requirements for Sterile …

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

The design of packaging which is able to maintain sterility of the device through its entire lifetime it is essential during the design and development phase of the …

Clean or Sterile medical device: How clean …

https://starfishmedical.com/blog/clean-or-sterile-medical-device/

A SAL of 10-6 or better is recommended for devices that penetrate normally sterile tissue, breached skin, implanted devices, etc. SAL’s of 10-3 are used for …

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 13485:2016 – Managing the medical …

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

Sterilization requirements are spread throughout the whole ISO 13485:2016 standard. Let’s see a few of the most important ones. Sterile Medical Device …

Class I and Class II Device Exemptions | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/class-i-and-class-ii-device-exemptions

Devices which may not be subject to 510 (k) requirements include: Preamendments devices (please refer to FDA’s guidance “ Intent to Exempt Certain …

Shelf Life of Medical Devices | FDA

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/shelf-life-medical-devices

The purpose of this document is to: inform readers of the Food and Drug Administration (FDA) regulations and policies relating to shelf life of medical devices. discuss the …