Auszug
Eine Zusammenstellung harmonisierter Normen ist in der ISO 10993 gegeben, welche vom technischen Komitee 194 der Internationale Standard Organisation (ISO) erarbeitet wurde. Die ISO 10993 ist unterteilt in verschiedene Unternormen. ISO 10993-1 — Guidance on selection of tests — umfasst Richtlinien zur Betrachtung der Sicherheit von medizinischen Instrumenten und Implantaten. Diese können wie folgt zusammengefasst werden:
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1.
Charakterisierung der Materialien bezüglich ihrer chemischen Zusammensetzung, möglichen Verunreinigungen und Extraktionsstoffen.
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2.
Untersuchung des potentiellen Auftretens von herausgelösten Substanzen und Degradationsprodukten aus einem medizinischen Instrument oder Implantat.
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3.
Toxizitätsuntersuchung zur Ermittlung der toxischen Wirkung von herausgelösten Substanzen und Degradationsprodukten.
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4.
Durchführung der Tests gemäss GLP (good laboratory practice), ausgeführt von kompetenten und informierten Personen.
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5.
Die experimentell ermittelten Daten sollten den Behörden zur Verfügung gestellt werden können.
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6.
Bei Änderung der chemischen Zusammensetzung der Materialien oder der Herstellungsbedingungen sowie bei Einsatz für zusätzliche Indikationen sollte ein potentieller toxikologischer Effekt in Patienten aufgrund dieser Änderung untersucht werden.
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7.
Alle relevanten Daten, inklusive Informationen von nicht klinischen Quellen, klinischen Studien und Markterfahrungen sollte bei der Evaluation eines Medizinproduktes berücksichtigt werden.
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Wintermantel, E., Shah-Derler, B., Bruinink, A., Petitmermet, M., Blum, J., Ha, S.W. (2008). Biokompatibilität. In: Medizintechnik Life Science Engineering. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-540-74925-7_3
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