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The U.S. Food and Drug Administration (FDA) recently updated its Recognized Consensus Standards database. This latest update, known as “List 63,” includes the following changes and others:
Newly recognized standards for medical device sterilization and interoperability
- ISO 11737-3 First edition 2023-06 Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing
- ISO 13004 First edition 2022-10 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD
- ISO/IEEE 11073-10701 First Edition, 2024-09 Health informatics — Device interoperability - Part 10701: Point-of-care medical device communication — Metric provisioning by participants in a Service-oriented Device Connectivity (SDC) system
New versions of existing recognized standards
- ANSI/AAMI ST24:2024 General-purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities
- ANSI/AAMI ST58:2024 Chemical sterilization and high-level disinfection in health care facilities
- AAMI TIR17:2024 Compatibility of materials subject to sterilization
- ASTM F1862/F1862M-24 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
Please check the Recognized Consensus Standards database for all of the updates. Go to “Sort” and select “Date of Entry (9-0).” Then click “Search.” The newest recognition decisions appear at the top of the list.
The next Federal Register notice announcing List 63 will be published later this year, though manufacturers may now cite these new and revised standards in device submissions.
Questions?
If you have questions about this update, contact the Division of Industry and Consumer Education.
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