Der Begriff Medizinprodukte:
\nBezeichnet Instrumente, Ger\u00e4te, Vorrichtungen, Materialien oder sonstige Gegenst\u00e4nde, die einzeln oder in Kombination am menschlichen K\u00f6rper angewendet werden, einschlie\u00dflich der erforderlichen Software. Die Wirkung auf die menschliche K\u00f6rperoberfl\u00e4che und in vivo wird nicht durch pharmakologische, immunologische oder metabolische Mittel erzielt, diese k\u00f6nnen jedoch beteiligt sein und eine gewisse unterst\u00fctzende Funktion erf\u00fcllen. Die Anwendung dient folgenden Zwecken:
\n(1) Pr\u00e4vention, Diagnose, Behandlung, \u00dcberwachung und Remission von Krankheiten.<\/p>\n
(2) Diagnose, Behandlung, \u00dcberwachung, Linderung und Entsch\u00e4digung bei Verletzungen oder Behinderungen.<\/p>\n
(3) Das Studium, die Ersetzung und die Anpassung anatomischer oder physiologischer Prozesse.<\/p>\n
(4) Schwangerschaftskontrolle<\/p>\n
Der Unterschied zwischen einem Arzneimittel und einem Medizinprodukt l\u00e4sst sich im Allgemeinen anhand des Verwendungszwecks sowie der beabsichtigten Hauptwirkung und -methode des Produkts definieren. Insbesondere die erwartete Funktion und Methode des Produkts sind wichtig. Diese Informationen lassen sich anhand der vom Hersteller bereitgestellten Produktetiketten, der in der Gebrauchsanweisung aufgef\u00fchrten Inhaltsstoffe und des Wirkmechanismus des Produkts analysieren.<\/p>\n
Grundlegende Qualit\u00e4tsmerkmale von Medizinprodukten:
\n1. Sicherheit
\n(1) Medizinische Ger\u00e4te mit elektrischem Antrieb: Die Sicherheit dieser Art von Ger\u00e4ten betrifft haupts\u00e4chlich die elektrische Sicherheit, einschlie\u00dflich des Schutzes vor Stromschl\u00e4gen und mechanischen Gefahren usw., die in speziellen Sicherheitsnormen f\u00fcr medizinische elektrische Ger\u00e4te festgelegt sind.<\/p>\n
(2) Medizinische Ger\u00e4te ohne Stromversorgung: Die wichtigsten Aspekte sind die Sicherheitsanforderungen hinsichtlich bakterieller Infektionen und Biokompatibilit\u00e4t. Nat\u00fcrlich gibt es bei manchen medizinischen elektrischen Ger\u00e4ten auch Probleme hinsichtlich Sterilit\u00e4t und Biokompatibilit\u00e4t im menschlichen K\u00f6rper, und diese Sicherheitsaspekte m\u00fcssen ber\u00fccksichtigt werden.<\/p>\n
2. Wirksamkeit.
\nDer Kernpunkt ist: Kann es wirklich den in der Gebrauchsanweisung beschriebenen Zweck einer wirksamen Diagnose, Behandlung und Krankheitsvorbeugung erreichen?<\/p>","protected":false},"excerpt":{"rendered":"
The concept of medical devices: Refers to the instruments, equipment, appliances, materials or other items used alone or in combination 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