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ONORM EN ISO 25539-2 : 2013

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS (ISO 25539-2:2012)
Withdrawn date

03-01-2021

Published date

01-12-2013

Dieser Teil der ISO 25539 legt auf der Grundlage des derzeitigen medizinischen Wissensstandes Anforderungen an Gefässstents fest. Im Hinblick auf die Sicherheit enthält sie Anforderungen an die beabsichtigte Funktion, Konstruktionsmerkmale, Werkstoffe/Materialien, die Bewertung der Konstruktion, die Herstellung, die sterile Verpackung sowie die Bereitstellung von Informationen durch den Hersteller. Sie sollte als Ergänzung zur ISO 14630 angesehen werden, die allgemeine Anforderungen an die Funktion nichtaktiver chirurgischer Implantate festlegt.

DevelopmentNote
Supersedes ONORM EN 14299. (01/2009)
DocumentType
Standard
PublisherName
Osterreichisches Normungsinstitut/Austrian Standards
Status
Withdrawn
SupersededBy

Standards Relationship
EN ISO 25539-2:2012 Identical
ISO 25539-2:2012 Identical

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ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
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ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

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