FDA-Recognized Consensus Standards
FDA recognizes standards from AAMI, ASTM, ANSI, ISO, and IEC. Use of recognized standards streamlines 510(k) and PMA review.
Electrical Safety
| Standard | Title |
|---|---|
| ANSI/AAMI ES60601-1:2005+A1:2012 | Medical electrical equipment — General |
| IEC 60601-1-2:2014+AMD1:2020 | EMC requirements |
| IEC 60601-1-6:2010+AMD2:2020 | Usability |
Biocompatibility
| Standard | Title |
|---|---|
| ISO 10993-1:2018 | Biological evaluation — Part 1 |
| ISO 10993-5:2009 | Cytotoxicity tests |
Software
| Standard | Title |
|---|---|
| IEC 62304:2006+AMD1:2015 | Medical device software lifecycle |
| IEC 82304-1:2016 | Health software — General requirements |
Risk Management
| Standard | Title |
|---|---|
| ISO 14971:2019 | Risk management for medical devices |
Sterilization
| Standard | Title |
|---|---|
| ISO 11135:2014 | EO sterilization |
| ANSI/AAMI ST67:2011 | Sterilization of health care products |
TIP
Search all FDA-recognized standards: accessdata.fda.gov