Table 6.
Standards recommended by the FDA
| Category | Standard |
|---|---|
| Electrical | |
| Software (Entire lifecycle) | IEC 62304 Ed. 1.1 2015–06 |
| EMC/EMI | AAMI/ANSI/IEC 60601-1-2:2014 |
| Electrical safety testinga | IEC 60601-1:2005 (ReWalk™) ANSI/AAMI ES60601-1:2005/(R)20I2 (Indego) |
| Medical electrical equipment (Home use) | ANSI/AAMI HA60601-1-11:20I5 |
| Mechanical | |
| Durability testing (used in prosthetics) | ISO 10328:2006 |
| Cyclic loading testing (used in prosthetics) | ISO 22675:2006 |
| Particle ingress | ANSI IEC 60529:2004 |
| General | |
| Risk management | ISO 14971:2007 |
| Quality management | ISO 13485:2003 |
| Labeling | ISO 15223-1:20I2 |
| Biocompatibility | ISO 10993-1:2009 |
| Human factors engineering | AAMI ANSI HE75:2009/(R)2013 |
| Training | AAMI TIR49:2013 |
| Application of usability | AAMI ANSI IEC 62366-1:2015 |
| Lithium batteries | UL 1642 5th ed. |
Notes: While the FDA has not recommended any standards specifically applicable to powered exoskeletons, we include current related standards that FDA recommends for Class II medical devices and lower limb prostheses.
According to the AAMI website, AAMI 60601-1 3rd ed. is identical to IEC 60601-1 but includes deviations to comply with US National Electric Code (http://www.aami.org/productspublications/ProductDetail.aspx?ItemNumber=1578). These two standards are followed by Indego and ReWalk, respectively.
Abbreviations: AAMI, Association for the Advancement of Medical Instrumentation; ANSI, American National Standards Institute; EMC, electromagnetic compatibility; EMI, electromagnetic interference; FDA, US Food and Drug Administration; IEC, International Electrotechnical Commission; ISO, International Organization for Standardization.