TABLE I. (Continued) Current Standards Related to End-Effector Devices.
| Standard | Description | ||||
|---|---|---|---|---|---|
| Electrical Specifications | IEC 60601-1:2005+AMD1:2012, ANSI/AAMI ES60601-1:2005/(R)2012, IEC 80601-2-78:2019 | General safety | |||
| IEC 60601-2-10:2012+AMD1:2016 | Stimulator safety | ||||
| IEC 60601-2-40:2016 | EMG safety | ||||
| IEC 60601-1-2:2014, ETSI EN 301 489-1, ETSI EN 301 489-3 , BS EN 50561-1:2013 | Electromagnetic | ||||
| IEC 62304:2006+AMD1:2015 | Software | ||||
| IEC 60601-1-10:2007+AMD1:2013 | Closed-loop control | ||||
| ANSI/AAMI HA60601-1-11:2015 | Devices for home healthcare | ||||
| ANSI/IEC 60529-2004 | Electrical enclosure | ||||
| UL 1642 5th Ed. | Lithium Batteries | ||||
|
ISO/WD 7176-14, ISO 7176-4:2008 |
Wheelchair power/controls | ||||
| IEEE 1856 | Prognostics & Health Management of Electronic Systems | ||||
| Mechanical |
ISO 10328:2016, ISO 15032:2000, ISO 22675:2016, ISO/TR 22676:2006, ISO/TS 16955:2016, ISO 22523:2006 , |
Requirements and testing | |||
| ISO 7176-6:2001, ISO 7176-2:2017 | Wheelchair speed and dynamics | ||||
| General | ISO 14971:2007 | Risk management | |||
| ISO 13485:2016, ISO 9001:2015 | Quality management of medical devices | ||||
| ISO 15223-1:2016 | Labeling | ||||
| ISO 10993-1:2009 , ISO 10993-10:2010 , ISO 10993-5:2009 | Biocompatibility | ||||
| AAMI ANSI HE75:2009/(R)2013 | Human factors engineering | ||||
| AAMI TIR49:2013 | Instructional materials | ||||
| AAMI ANSI IEC 62366-1:2015 | Application and usability | ||||
| ISO 14001:2015 | Environmental management | ||||
| WHO standards for prosthetics and orthotics. Geneva: World Health Organization; 2017. License: CC BY-NC-SA 3.0 IGO. | Global standards for prosthetics and orthotics | ||||
| Definition & Terminology |
ISO 8548-1:1989
,
ISO 8548-2:1993
,
ISO 8548-3:1993 , ISO 8548-4:1998 , ISO 8548-5:2003 , |
Limb deficiencies | |||
|
ISO 8549-1:1989
,
ISO 8549-2:1989
,
ISO 8549-3: 1989 , ISO 8549-4:2014 |
Prosthetics & orthotics vocabulary | ||||
|
ISO 8551:2003
,
ISO 21065:2017
,
ISO 29781:2008 , ISO 29782:2008 |
Functional deficiencies & rehabilitation | ||||
| ISO 29783-1:2008 , ISO 29783-2:2015 , ISO 29783-3:2016 | Human gait | ||||
|
ISO 13404:2007, ISO 13405-1:2015, ISO 13405-2:2015, ISO 21064:2017, ISO 21063:2017 |
Prosthetics & Orthotics components | ||||
|
IEEE 1872-2015
,
IEEE P1872.1
,
IEEE 7007 , IEEE 7008 |
Robotics | ||||
| IoT | IEEE 1451-99 | Harmonization and Security | |||
| IEEE 2413 | Architectural Framework | ||||
| Standard | Description | ||||
| IEEE 2510 | Sensor performance & Quality | ||||
| Virtual Reality & Augmented Reality | IEEE 2048.1 | Definitions | |||
| IEEE 2048.2 , 2048.3 , 2048.7 , 2048.8 | Visual | ||||
| IEEE 2048.9 , 2048.10 | Audio | ||||
| IEEE 2014.6 | Interface | ||||
| IEEE 3333.1.1-2015 | User Experience | ||||
| IEEE 2048.4 | Person Identify | ||||
| IEEE 2048.5 | Safety | ||||
| IEEE 2048.12 | Content ratings | ||||
| Implants (e.g., Osseointegrated Devices) | Materials | ISO 5832-3:2016 | Wrought titanium 6-aluminium 4-vanadium alloy | ||
| ASTM F136-13 | Wrought titanium-6 aluminum-4 vanadium ELI (extra low interstitial) | ||||
| ASTM F67-13 | Unalloyed titanium | ||||
| ASTM F899-12b | Wrought Stainless Steels | ||||
| Mechanical | ASTM F88/F88M-09 | Seal strength | |||
| ISO 10993-18:2005 | Chemical Characterization | ||||
| ISO 11607-2:2006 | Forming, Sealing & Assembly processes | ||||
| ASTM F1929-12 | Detecting seal leaks | ||||
| General | ISO 14971:2007 | Risk Management | |||
| ISO 15223-1:2016 | Labeling | ||||
| ISO 14644-1:2015 | Controlled Environments | ||||
| IEC 62366-1:2015 | Usability | ||||
| BS EN 1041 | Device Information | ||||