ISO 25539 PDF

Part 1: Endovascular prostheses. Implants cardiovasculaires — Dispositifs endovasculaires —. Partie 1: Prothèses endovasculaires. STANDARD. ISO. ISO Cardiovascular implants—. Endovascular devices—Part 1: Endovascular prostheses. American. National. Standard. PREVIEW COPY. ISO /. A/. (R) Cardiovascular implants —. Endovascular devices —. Part 1: Endovascular prostheses —. Amendment 1: Test methods.

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Similarly, specific prosthesis configurations e.

Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document. Guidance for io development of in vitro test methods is included in an informative annex to this document. Final text received or FDIS registered for formal approval. Although contra-lateral iliac artery occluders when used as an is part of aorto-uni-iliac endovascular prosthesis are within the scope of this document, specific requirements and testing are not described for these devices.

Radial Force ISO

This document can be considered as a supplement to ISOwhich specifies general requirements for the performance of non-active surgical implants. Proof sent to secretariat or FDIS ballot initiated: This document can be considered as a supplement to ISOwhich specifies general requirements for the performance of non-active surgical implants.

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.

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.

BS EN ISO 25539-1:2009

The valve component of valved conduits constructed with an endovascular prosthesis component and the combination of the valved component and the endovascular prosthesis component are excluded from the scope of this document. 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 jso these devices.

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This document can be helpful in identifying the appropriate evaluation of the endovascular prosthesis component of a 25539 conduit, but specific requirements and testing are not described for these devices.

Balloons used to achieve adequate apposition of the prosthesis with the vessel wall or overlapping components are within the scope of this document, oso if they are not integral to the endovascular system. Guidance for the development of in vitro test methods is included in an informative annex to this document. Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document.

Similarly, specific prosthesis configurations e. The requirements for, and the evaluation of, degradation and other time-dependant aspects of absorbable materials used in the construction of endovascular prostheses are not addressed in this document.

Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses.

Life cycle A standard is reviewed every 5 years 00 Preliminary. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e. This document isl be considered as a supplement to ISOwhich 255539 general requirements for the performance of non-active surgical implants. The valve component of valved conduits constructed with an endovascular prosthesis component and the combination of the valved component and the endovascular prosthesis component are excluded from the scope of this document.

Similarly, specific prosthesis configurations e. Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document. Although contra-lateral iliac artery occluders when used 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. The requirements for, and the evaluation of, degradation and other time-dependant aspects of absorbable materials used in the construction of endovascular prostheses are not addressed in this document.

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Kontakt venligst Dansk Standard. The valve component of valved conduits constructed with an endovascular prosthesis component and the combination of the valved component and the endovascular prosthesis component are excluded from the scope of this document. Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses. The requirements for, and the evaluation of, degradation and other time-dependant aspects of absorbable materials used in the construction of endovascular prostheses are not addressed in this document.

Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses ISO 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.

Although contra-lateral iliac artery occluders when used as an integral part of aorto-uni-iliac endovascular prosthesis are within the scope of this document, specific requirements is testing are not described for these devices. Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e.

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

ISO – Cardiovascular implants — Endovascular devices — Part 2: Vascular stents

Forkert brugernavn eller adgangskode. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e. Monday to Friday – Check out our FAQs.