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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

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

Journal of Polish Safety and Reliability Association

2017

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.