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S-Charge User Guide
Quality Assurance
Steeper/SteeperUSA operate a quality management
system that fully complies with the requirements of
BS EN ISO 13485:2016. This certifies that Steeper/
SteeperUSA meet the appropriate international
quality standards for design, manufacture and supply
of prosthetic products.
Steeper is registered with both the Medicines and
Healthcare Regulatory Authority in the UK, and the
Food and Drugs Administration of the United States
Government for the manufacture and supply of
prosthetic and orthotic products.
MHRA Registration N°: 0000006617
FDA Registration N°: 9612243
Model N°: STP-RP616
Continued compliance with the standard is
monitored by a program of internal and external
audits.
Applied Standards:
Test Certification
The S-Charge System and its associated components
listed within this document have been tested
and certified to the following standards and
requirements:
• Medical Safety Testing:
• IEC 60601-1: 2005/AMD1:2012
• IEC 60601-1-11: 2015; Includes meeting
requirements: ISO 14971:2019
• IEC 60601-2: 2014
• IP22 to BS EN 60529: 1992+ A2: 2013, when the
S-Charge display is sealed using the silicone
sealant during fitting.
• IEC62133-2:2017
• UN38.3
