ISO 25539-1 PDF

Reference number. ISO (E). This is a preview of “ISO “. Click here to purchase the full version from the ANSI store. Buy I.S. EN ISO CARDIOVASCULAR IMPLANTS – ENDOVASCULAR DEVICES – PART 1: ENDOVASCULAR PROSTHESES. Buy AAMI ISO Cardiovascular Implants – Endovascular Devices – Part 1: Endovascular Prostheses from SAI Global.

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Guidance for the development of in vitro test methods is included in an informative annex to this document.

Dauerhaftigkeitsprüfung an endovaskulären Prothesen nach ISO

Related international standards This standard is identical to: Guidance for the development of in vitro test methods is included in an informative annex to this document.

Similarly, specific prosthesis configurations e. Forkert brugernavn eller adgangskode. Du abonnerer allerede dette emne. This document can be helpful in identifying the appropriate evaluation of the endovascular prosthesis component of a valved conduit, but specific requirements and testing are not described for these devices. Please contact the ISRM info center. The valve component of valved conduits constructed 25539-1 an endovascular prosthesis component and the combination of the valved component and the endovascular prosthesis component are excluded from the scope of this document.

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Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses iwo. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e.

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Cardiovascular implants – Endovascular devices – Part 2: Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e. Monday to Friday – Although contra-lateral iliac artery occluders when 2553-1 as an integral part of aorto-uni-iliac endovascular prosthesis are within the scope of this document, specific requirements and testing are not described for these devices.

BS EN ISO – Cardiovascular Implants. Endovascular devices. Endovascular prostheses

The requirements for, and the evaluation of, degradation and other time-dependant aspects of isl materials used in the construction of endovascular prostheses are not addressed in this document. Final text received or FDIS registered for formal approval. The following bibliographic material is provided to assist you with your purchasing decision: Although contra-lateral iliac artery occluders when used as an integral part of aorto-uni-iliac 25539-11 prosthesis are within the scope of this document, specific requirements and testing are not described for these devices.

Document Number ISO Guidance for the development of in vitro test methods is included in an informative annex to this document. Cardiovascular implants – Endovascular devices – Part 1: Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document. This document is available in either Paper or PDF format.

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EN ISO 25539-1:2009

Vena cava filters ISO This document can be considered as a supplement to ISOwhich specifies general requirements for the performance of non-active surgical implants. Ido Us Info center Standardization.

Pharmacological aspects of drug eluting or drug coated endovascular isoo are not addressed in this document. Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses.

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Balloons used to achieve adequate apposition of the prosthesis with the vessel wall or overlapping components are within the scope of this document, even if they are not integral to the endovascular system. Similarly, specific prosthesis configurations e. This document can be helpful in identifying the appropriate evaluation of the endovascular prosthesis component of a valved conduit, 52539-1 specific requirements and testing are not described for these devices.

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