Please see this list of FDA consensus standards (updated last month). Of note are the items below including AAMI TIR45 on AGILE practices in software development, and the updated Common Vulnerability Scoring System (CVSS), noting that both 3.1 and 4.0 are recognised, but that the period for which 3.1 is recognised is 7 months then 4.0 is recognised. As usual, if recognition is partial refer to the FDA database Recognized Consensus Standards: Medical Devices for the explanation of the degree of recognition etc.
General I (QS/RM
| 5-145 | Complete | IEC | 60417:2025 DB | Graphical symbols for use on equipment |
General II (ES/EMC)
| 19-54 | Complete | IEC | 60086-5 Edition 5.0 2021-09 | Primary batteries – Part 5: Safety of batteries with aqueous electrolyte [Including: Corrigendum 1 (2022)] |
| 19-55 | Complete | IEC | 62133-2 Edition 5.0 2021-09 | Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells and for batteries made from them for use in portable applications – Part 2: Lithium systems |
| 19-56 | Complete | IEC | 60086-4 Edition 6.0 2025-01 | Primary batteries – Part 4: Safety of lithium batteries |
IVD
| 7-328 | Partial | CLSI | M100 35th Edition | Performance Standards for Antimicrobial Susceptibility Testing |
| 7-329 | Complete | CLSI | EP06-EG 2nd Edition | Developer Validation of Linearity Establishment Guide |
| 7-330 | Partial | CLSI | M38M51S 3rd Edition | Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi |
| 7-331 | Complete | CLSI | AUTO02-A2 | Laboratory Automation: Bar Codes for Specimen Container Identification – Second Edition |
| 7-332 | Complete | CLSI | AUTO01-A | Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard |
| 7-333 | Complete | CLSI | AUTO04-A | Laboratory Automation: Systems Operational Requirements Characteristics and Information Elements; Approved Standard |
| 7-334 | Complete | CLSI | AUTO05-A | Laboratory Automation: Electromechanical Interfaces; Approved Standard |
| 7-335 | Complete | CLSI | POCT01-A2 | Point-of-Care Connectivity – Second Edition |
| 7-336 | Complete | CLSI | LIS02-A2 | Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard-Second Edition. |
| 7-337 | Complete | CLSI | AUTO08-A | Managing and Validating Laboratory Information Systems; Approved Guideline |
| 7-338 | Complete | CLSI | AUTO10-A | Autoverification of Clinical Laboratory Test Results; Approved Guideline |
| 7-339 | Complete | CLSI | AUTO09-A | Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard |
| 7-340 | Complete | CLSI | LIS01-A2 | Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems – Second Edition. |
| 7-341 | Complete | CLSI | AUTO03-A2 | Laboratory Automation: Communications with Automated Clinical Laboratory Systems Instruments Devices and Information Systems; Approved Standard – Second Edition |
| 7-342 | Complete | CLSI | AUTO12-A | Specimen Labels: Content and Location Fonts and Label Orientation; Approved Standard |
| 7-343 | Complete | CLSI | AUTO07-A | Laboratory Automation: Data Content for Specimen Identification; Approved Standard |
| 7-344 | Complete | CLSI | AUTO11-A2 | Information Technology Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard – Second Edition. |
| 7-345 | Complete | CLSI | AUTO13-A2 (Formerly GP19-A2) | Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation Operation and Monitoring; Approved Guideline – Second Edition |
Software and Infomatics
| 13-140 | Complete | FIRST | CVSS v4.0 | Common Vulnerability Scoring System version 4.0 |
| 13-142 | Complete | FIRST | CVSS v3.1 | Common Vulnerability Scoring System version 3.1 |
| 13-143 | Complete | AAMI | TIR45:2023 | Guidance on the use of AGILE practices in the development of medical device software |
| 13-144 | Complete | IEEE | Std 11073-10425-2023 | Health informatics – Device Interoperability Part 10425: Personal Health Device Communication – Device Specialization – Continuous Glucose Monitor (CGM) |
| 13-144 | Complete | ISO IEEE | 11073-10425 Edition 3 2024-09 | Health informatics – Device interoperability Part 10425: Personal health device communication – Device specialization – Continuous Glucose Monitor (CGM) |
| 13-145 | Complete | IEEE | Std 11073-10419:2023 | Health informatics – Device Interoperability Part 10419: Personal health device communication – Device Specialization – Insulin Pump |
| 13-148 | Complete | IEEE | Std 11073-10417-2023 | Health informatics – Device Interoperability Part 10417: Personal health device communication – Device Specialization – Glucose Meter |
Sterility
| 14-610 | Complete | ISO | 11138-7 First edition 2019-03 | Sterilization of health care products – Biological indicators – Part 7: Guidance for the selection use and interpretation of results |
| 14-611 | Complete | ISO | 11137-1 Second edition 2025-04 | Sterilization of health care products – Radiation – Part 1: Requirements for the development validation and routine control of a sterilization process for medical devices |
