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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,
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Safety assurance: certification
Conclusion
References
Manufacturer
Integrated surgical systems, which markets the Robodoc medical robot: ISS Inc, USA, http://www.robodoc.com
Organizations
Institut européen de cindyniques : http://www.cindynics.org
Institut National de Recherche et de Sécurité (INRS) http://www.inrs.fr
Occupational Safety and Health Administration (OSHA) http://www.osha.gov
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