Safety assurance: certification
Security systems in medical robotics
Article REF: SE3781 V1
Safety assurance: certification
Security systems in medical robotics

Authors : Jérémie GUIOCHET, Gilles MOTET, Bertrand TONDU, Claude BARON

Publication date: April 10, 2007 | Lire en français

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5. Safety assurance: certification

The purpose of certification is to provide a customer with a guarantee that a product conforms to its specification, particularly in terms of safety. In our case, safety specifications are at the heart of the matter. This certification is generally issued by a third-party organization such as G-MED in the medical field, which has been focusing on medical robots for some years now. This section summarizes how medical robotics systems deal with certification.

5.1 Certification and risk

Although risk analysis alone is not enough to obtain certification, it nevertheless forms the core of today's main certification requirements. To harmonize and ensure a high level of safety, three European directives, [1]

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