Quality Assurance - be bionic steeper Technical Manual

6.2 Quality Assurance

Steeper / 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 Steeper / SteeperUSA
meet the appropriate international quality standards for design, manufacture and supply of prosthetic products
and user software.
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 prosthetics and
orthotics products.
MHRA Registration N°: CA001031
FCC Registration N° : QOQBLE113
Model N°: RSL-RP608
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
BS EN 60601-1-2006
BS EN 60950-1-2006
ETSI 300 440-2 V1.3.1 (2009-03)
ETSI 301 489-3 V1.4.1 (2002-08)
Additional internal and external test results and associated project documentation can be found in the
Technical File RP609.
8747
FDA Registration N° : 9612243
IC : 5123A-BGTBLE113
Electromagnetic Compatibility for Electronic Hand (EMC)
Medical Electrical Essential requirements for Safety
Information Technology Equipment for Safety
Electromagnetic Compatibility for RF Module
Electromagnetic Compatibility for RF Module
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