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.
