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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This document can be helpful ios identifying the appropriate evaluation of the endovascular prosthesis component of a valved conduit, but specific requirements and testing are not described for these devices. Some of the requirements are specific to endovascular treatment of arterial ixo or stenoses. Cardiovascular implants – Endovascular devices – Part 1: 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.

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

Life cycle A standard is reviewed every 5 years 00 Preliminary. 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.

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.

Forkert brugernavn eller adgangskode. 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.

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This document can be considered as a supplement to ISOwhich specifies general requirements for the performance of 52539 surgical implants. Guidance for the development of in vitro test methods is included in an informative annex to this document. Vis ikke denne igen. Final text received or FDIS registered for formal approval.

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. Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document. This document can be considered as a supplement io ISOwhich specifies general requirements for the performance of non-active surgical implants.

Similarly, specific prosthesis configurations e. Monday to Friday – Guidance for the development of in vitro test methods is included in an informative annex to this document.

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

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

Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e. Guidance for the development of in vitro test methods is included in an informative annex to this document.

Check out our FAQs. 225539 abonnerer allerede dette emne. Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses.

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. Kontakt venligst Dansk Standard. Proof sent to secretariat or FDIS ballot initiated: 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.

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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. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e. 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 and testing are not described for these devices. Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document. The requirements for, and the evaluation of, degradation and other time-dependant aspects of absorbable materials used in the construction io endovascular prostheses are not addressed in this document.

This document can be considered as a supplement to ISOwhich specifies general requirements for the performance of non-active surgical implants. Similarly, specific prosthesis configurations e.

The requirements for, and the evaluation of, degradation and other 255539 aspects of absorbable materials used in the construction of endovascular prostheses are not addressed in this document.