FDA-Recognized Consensus Standards
FDA recognizes standards from AAMI, ASTM, ANSI, ISO, and IEC. Declaration of Conformity to recognized standards streamlines 510(k) and PMA review.
TIP
Search all FDA-recognized standards: accessdata.fda.gov
Electrical Safety
| Standard | Title |
|---|---|
| ANSI/AAMI ES60601-1:2005+A1:2012+A2:2020 | Medical electrical equipment — General requirements |
| IEC 60601-1-2:2014+AMD1:2020 | EMC requirements |
| IEC 60601-1-6:2010+AMD2:2020 | Usability |
| IEC 60601-1-8:2006+AMD1:2012+AMD2:2020 | Alarm systems |
| IEC 60601-1-9:2007+AMD1:2013 | Environmentally conscious design |
| IEC 60601-1-11:2015+AMD1:2020 | Home healthcare environment |
| IEC 60601-1-12:2014+AMD1:2020 | Emergency medical services environment |
| ANSI/AAMI PC69:2007 | Active implantable medical devices — EMC |
Biocompatibility
| Standard | Title |
|---|---|
| ISO 10993-1:2018 | Biological evaluation — Evaluation and testing within a risk management process |
| ISO 10993-5:2009 | Tests for in vitro cytotoxicity |
| ISO 10993-10:2021 | Tests for skin sensitization |
| ISO 10993-18:2020 | Chemical characterization of medical device materials |
| ISO 10993-23:2021 | Tests for irritation |
| ASTM F748 | Standard Practice for Selecting Generic Biological Test Methods |
Software & Cybersecurity
| Standard | Title |
|---|---|
| IEC 62304:2006+AMD1:2015 | Medical device software — Software life cycle processes |
| IEC 82304-1:2016 | Health software — General requirements for safety |
| IEC 81001-5-1:2021 | Health software and health IT systems safety — Cybersecurity |
| AAMI TIR57:2016 | Principles for medical device security — Risk management |
Risk Management
| Standard | Title |
|---|---|
| ISO 14971:2019 | Application of risk management to medical devices |
| ISO 24971:2020 | Guidance on the application of ISO 14971 |
Usability
| Standard | Title |
|---|---|
| IEC 62366-1:2015+AMD1:2020 | Medical devices — Application of usability engineering |
| AAMI HE75:2009/(R)2018 | Human factors engineering — Design of medical devices |
Sterilization
| Standard | Title |
|---|---|
| ISO 11135:2014 | Sterilization of health care products — Ethylene oxide |
| ANSI/AAMI ST67:2011/(R)2018 | Sterilization of health care products — "STERILE" label requirements |
| ISO 11137 series | Sterilization using radiation |
| ASTM F2132 | Accelerated Aging of Sterile Barrier Systems |
Quality Management
| Standard | Title |
|---|---|
| ISO 13485:2016 | Medical devices — Quality management systems |
| ANSI/AAMI/ISO 13485:2016 | US adoption of ISO 13485 |
Packaging
| Standard | Title |
|---|---|
| ASTM F2475 | Biocompatibility Evaluation of Medical Device Packaging Materials |
| ISO 11607 series | Packaging for terminally sterilized medical devices |