FprEN ISO 14630
(Main)Non-active surgical implants - General requirements (ISO/FDIS 14630:2024)
Non-active surgical implants - General requirements (ISO/FDIS 14630:2024)
Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO/FDIS 14630:2024)
Dieses Dokument legt allgemeine Anforderungen an nichtaktive chirurgische Implantate fest, die im Folgenden Implantate genannt.
Dieses Dokument gilt nicht für Zahnimplantate, Zahnrestaurations¬materialien, transendodontische und transradikuläre Implantate, intraokulare Linsen, und Implantate, die lebensfähiges tierisches oder menschliches Gewebe verwenden.
In Bezug auf die Sicherheit legt dieses Dokument Anforderungen an die beabsichtigte Funktion, an Konstruktionsmerkmale, Werkstoffe, Designprüfung, Herstellung, Sterilisation, Verpackung und die durch den Hersteller bereitgestellten Informationen fest sowie Prüfverfahren, um die Einhaltung dieser Anforderungen nachzuweisen.
Die Normen der Ebene 2 und Ebene 3 enthalten oder verweisen auf zusätzliche Anforderungen an spezifische Implantate oder Implantatfamilien.
ANMERKUNG 1 Dieses Dokument fordert vom Hersteller kein Qualitätsmanagementsystem. Allerdings fordern viele Zulassungsbehörden die Anwendung eines Qualitätsmanagementsystems, wie beispielsweise das in ISO 13485 beschriebene, um sicherzustellen, dass das Implantat seine beabsichtigte Funktion und Sicherheit erfüllt.
ANMERKUNG 2 Soweit nicht anderweitig festgelegt, bezieht sich die Benennung „Implantat“ in diesem Dokument auf jede einzelne Komponente eines Systems oder eines modularen Implantats, die gesondert oder als Komponentensatz bereitgestellt wird, sowie auf alle ergänzenden oder zugehörigen Implantate, die dafür ausgelegt sind, die beabsichtigte Funktion zu verbessern.
Implants chirurgicaux non actifs - Exigences générales (ISO/FDIS 14630:2024)
Neaktivni kirurški vsadki (implantati) - Splošne zahteve (ISO/FDIS 14630:2024)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 14630:2022
01-november-2022
Neaktivni kirurški vsadki (implantati) - Splošne zahteve (ISO/DIS 14630:2022)
Non-active surgical implants - General requirements (ISO/DIS 14630:2022)
Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO/DIS 14630:2022)
Implants chirurgicaux non actifs - Exigences générales (ISO/DIS 14630:2022)
Ta slovenski standard je istoveten z: prEN ISO 14630
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 14630:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 14630:2022
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oSIST prEN ISO 14630:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 14630
ISO/TC 150 Secretariat: DIN
Voting begins on: Voting terminates on:
2022-09-16 2022-12-09
Non-active surgical implants — General requirements
Implants chirurgicaux non actifs — Exigences générales
ICS: 11.040.40
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
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oSIST prEN ISO 14630:2022
ISO/DIS 14630:2022(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 14630
ISO/TC 150 Secretariat: DIN
Voting begins on: Voting terminates on:
Non-active surgical implants — General requirements
Implants chirurgicaux non actifs — Exigences générales
ICS: 11.040.40
This document is circulated as received from the committee secretariat.
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NATIONAL REGULATIONS.
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PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022
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oSIST prEN ISO 14630:2022
ISO/DIS 14630:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions .
...
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