FDA added three standards to the US Consensus Standards list in September for sterility.
| Date of Entry |
Specialty Task Group Area |
Recognition Number |
Extent of Recognition |
Standards Developing Organization |
Standard Designation Number and Date |
Standard Title (click for recognition information) |
| 09/09/2024 | Sterility | 14-460 | Complete | ISO | 11140-1 Third edition 2014-11-01 | Sterilization of health care products – Chemical indicators – Part 1: General requirements |
| ANSI AAMI ISO | 11140-1:2014 | Sterilization of health care products – Chemical indicators – Part 1: General requirements | ||||
| 09/09/2024 | Sterility | 14-604 | Complete | ISO | 11737-3 First Edition 2023-06 | Sterilization of health care products – Microbiological methods – Part 3: Bacterial endotoxin testing |
| 09/09/2024 | Sterility | 14-605 | Complete | ISO | 13004 First edition 2022-10 | Sterilization of health care products – Radiation – Substantiation of selected sterilization dose: Method VDmaxSD |
| ANSI AAMI ISO | 13004:2022 | Sterilization of health care products – Radiation – Substantiation of selected sterilization dose: Method VDmaxSD |
