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 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 isso.

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. This document can be considered as a supplement to ISOwhich specifies general requirements for the performance of non-active surgical implants. 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.

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.

Du abonnerer allerede dette emne. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e. Final text received or FDIS registered for formal approval. Cardiovascular implants – Endovascular devices – Part 1: 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 of endovascular prostheses are not addressed in this document.

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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 isk.

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

BS EN ISO 25539-1:2009

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

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

Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e. Monday to Friday – This document can be considered as a supplement to ISOwhich specifies general requirements for the performance of non-active surgical implants. 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. 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. Kontakt venligst Dansk Standard. Life cycle A standard is reviewed every 5 years 00 Preliminary. Proof sent to secretariat or FDIS ballot initiated: 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 are excluded from the scope of this document.

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Endovascular prostheses ISO 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. Check out our FAQs.

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

Pharmacological aspects of drug eluting or drug coated endovascular sio are not addressed in this document. Vis ikke denne igen.

Radial Force ISO

Balloons used to achieve adequate apposition kso 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. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e.

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