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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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.

Proof sent to secretariat or FDIS ballot initiated: 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. Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document. Guidance for the development of isl vitro test methods isp included in an informative annex to 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. 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.

Similarly, specific prosthesis configurations e. The valve component of valved conduits constructed with an endovascular prosthesis component and the combination of the valved component and the endovascular prosthesis component 2559 excluded from the scope of this document. Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document.

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This document can be considered as a supplement to ISOwhich specifies general requirements for the performance of non-active isoo implants. Vis ikke denne igen. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e.

Cardiovascular implants – Endovascular devices – Part 1: Although uses of endovascular systems other than treatment of arterial aneurysms or isso 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. Similarly, specific prosthesis configurations e.

BS EN ISO 25539-1:2009

Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses. Monday to Friday – 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 2539 of aorto-uni-iliac endovascular prosthesis are within the scope of this document, specific requirements and testing are not described for these devices.

Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document. Forkert brugernavn eller adgangskode.

Radial Force ISO

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

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Final text received or FDIS registered for formal approval.

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

Life cycle A standard is reviewed every 5 years 00 Preliminary. Du abonnerer allerede dette emne.

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

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

This document can be considered as a supplement to ISOwhich specifies general requirements for the performance of non-active surgical implants. Endovascular prostheses ISO Some of the requirements are specific to uso 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 255539 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.

Similarly, specific prosthesis configurations e. Check out our FAQs. Kontakt venligst Dansk Standard.