- Tytuł:
- Risk assessment system in the production process of medical devices on the basis of dynamics spine corrector
- Autorzy:
-
Kaczmarek, W.
Kamiński, G.
Mianowski, K.
Rosołek, R.
Gołaszewski, T.
Woch, M.
Głyda, K. - Powiązania:
- https://bibliotekanauki.pl/articles/2068890.pdf
- Data publikacji:
- 2017
- Wydawca:
- Uniwersytet Morski w Gdyni. Polskie Towarzystwo Bezpieczeństwa i Niezawodności
- Tematy:
-
risk assessment
dynamics spine corrector
Risk Priority Number
scoliosis
rehabilitation of the spine - Opis:
- 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.
- Źródło:
-
Journal of Polish Safety and Reliability Association; 2017, 8, 1; 67--72
2084-5316 - Pojawia się w:
- Journal of Polish Safety and Reliability Association
- Dostawca treści:
- Biblioteka Nauki
Artykuł