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1 Journal of Polish Safety and Reliability Association

1 2017

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Risk assessment system in the production process of medical devices on the basis of dynamics spine corrector

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Kaczmarek W. , Kamiński G. , Mianowski K. , Rosołek R. , Gołaszewski T. , Woch M. , Głyda K.

2017

tom Vol. 8, No. 1

67--72

The article presents the methodology involved in creating a risk analysis of medical devices. General regulations contained in the PN-EN ISO 14971 provide manufacturers of medical basis for the concretization of standards in the form of risk assessment system for a particular process and product. However, there is no top-down regulations defining the level of acceptable risk and the decision to determine its value rests with the manufacturer. Effectiveness of taken measures was tested on the example of a analysis of dynamics spine corrector – medical device that is allowing independent rehabilitation under the supervision of a physiotherapist and current control of the kinematics and dynamics of the human spine.