|
 
The U.S. Food and Drug Administration (FDA) updated its Recognized Consensus Standards database. This latest update, known as “List 62,” includes new standards and new versions of recognized standards, as well as a revision to one standard’s extent of recognition.
Facts About the List 62 Updates
-
Two new Technical Information Reports (TIRs) related to medical device sterilization:
- AAMI TIR12:2020 (R2023) – Designing, Testing, And Labeling Medical Devices Intended for Processing By Health Care Facilities: A Guide for Device Manufacturers. This TIR provides direction to manufacturers to develop instructions for processing steps to accompany reusable and single-use medical devices processed by health care facilities prior to clinical use.
- AAMI TIR28:2016/(R)2020 Product Adoption and Process Equivalence for Ethylene Oxide. This TIR provides assistance to manufacturers and sterilizers when adding new or modified products to an existing validated ethylene oxide (EO) sterilization process. It also augments the FDA-recognized ANSI/AAMI/ISO 11135 standard.
-
Accreditation Scheme for Conformity Assessment
- An additional standard in the Basic Safety and Essential Performance scope of ASCA: ISO 80601-2-85:2021 (Edition 1.0) Medical electrical equipment: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment.
- New versions for five existing ASCA Basic Safety and Essential Performance standards
-
One standard changed from partial to complete recognition:
- ISO 5367 Fifth edition 2014-10-15 Anaesthetic and respiratory equipment – Breathing sets and connectors.
-
Interoperability Standards for Digital Health:
- Two new standards and six new versions of interoperability standards in the ISO/IEEE and IEEE 11073 series
The next Federal Register notice announcing List 62 will be published later in 2024, though manufacturers may now cite these new and revised standards in device submissions.
For more information, check the Recognized Consensus Standards database and the relevant Supplementary Information Sheets. To view the latest revisions to the database, click the “Search” button without entering anything. The results will automatically sort by date of entry.
To subscribe to CDRH’s new standards newsletter, visit the Subscribe to CDRH Email Lists web page. Sign up for the CDRH Industry or Science email distribution list.
Questions?
If you have questions, contact the Division of Industry and Consumer Education.
|
|
|
|
