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# CDRH Adds Device Sterilization Standards
- URL: https://www.fdaweb.com/cdrh-adds-device-sterilization-standards/
- Published: 2023-07-25T12:00:00.000Z
- Updated: 2026-09-14T18:46:11.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154944

CDRH is announcing new steps to improve medical device sterilization. For one, the Center has updated its [Recognized Consensus Standards database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/Search.cfm?ref=fdaweb.com) to include the complete recognition of one sterilization standard ([ISO 22441:2022](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard%5F%5Fidentification%5Fno=44295&ref=fdaweb.com)). The new standard, *Sterilization of Health Care Products — Low Temperature Vaporized Hydrogen Peroxide — Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices*, supports use of the converted gas as an alternative sterilization method.

The other step is CDRH’s recognition of two “Technical Information Reports” associated with medical device sterilization — [AAMI TIR 17:2017/(R)2020](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard%5F%5Fidentification%5Fno=44569&ref=fdaweb.com) *Compatibility of Materials Subjected to Sterilization* and [AAMI TIR104:2022](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard%5F%5Fidentification%5Fno=44296&ref=fdaweb.com) *Guidance on Transferring Health Care Products Between Radiation Sterilization Sources*.

“CDRH remains committed to encouraging novel ways to sterilize medical devices while reducing adverse impacts on the environment and public health and to developing solutions that avert potential shortages of devices that the American public relies upon," Center Office of Strategic Partnerships and Technology Innovation director **Suzanne Schwartz** is quoted in a [release](https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announces-new-standards-recognition-support-innovation-medical-device-sterilization?ref=fdaweb.com) announcing the new standards.