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FDA Recognizes Additional Standards to Advance Innovation in Sterilization Processes

The U.S. Food and Drug Administration (FDA) recently recognized the following sterilization standards to help advance innovation in medical device sterilization processes:

• ISO 11737-3:2023 Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing
• ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements

• ISO 13004:2022 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD 

By promoting the techniques in these international standards, the FDA is facilitating the adoption of sterilization of medical devices, enhancing quality and advancing international harmonization.

Citing FDA-recognized standards with a declaration of conformity generally reduces the amount of supporting documentation needed in a device submission. Learn more at the Division of Standards and Conformity Assessment’s web page.

Questions?

If you have questions about standards, contact the Division of Industry and Consumer Education.