BeBionic bebionic3, Technical Information, Page: 58 / 68

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6.4 Quality Assurance
RSLSteeper / SteeperUSA operate a UKAS approved quality management system and fully complies
with the requirements of BS EN ISO 9001:2008, ISO27001:2005 & TickIT Issue 5. This certifies that
RSLSteeper / SteeperUSA meet the appropriate international quality standards for design, manufacture
and supply of prosthetic products and user software.
RSLSteeper 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
prosthetics and orthotics products.
MHRA Registration N°: CA001031 FDA Registration N° : 9612243
FCC Registration N° : PBBGC350616 IC : 10634A-RSLRFBB
Model N°: RSL-RP609
Continued compliance with the standard is monitored by a programme of internal and external audits.
All individual products are marked indicating that they comply with the requirements of the Medical
Devices Directive 93/42/EEC (MDD).
The mark may be applied on packaging, accompanying literature or an enclosure, rather than the
product itself.
The bebionic hand and its associated components listed in this document are covered by test
certificates for:-
BS EN 60601-1-2-2007 Electromagnetic Compatibility for Electronic Hand (EMC)
BS EN 60601-1-2006 Medical Electrical Essential requirements for Safety
BS EN 60950-1-2006 Information Technology Equipment for Safety
ETSI 300 440-2 V1.3.1 (2009-03) Electromagnetic Compatibility for RF Module
ETSI 301 489-3 V1.4.1 (2002-08) Electromagnetic Compatibility for RF Module
Additional internal and external test results and associated project documentation can be found in the
Technical File RP609.
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