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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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.

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

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

Check out our FAQs. 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. 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.

Final text received or FDIS registered for formal approval. Similarly, specific prosthesis configurations 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. 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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BS EN ISO 25539-1:2009

Pharmacological aspects of drug eluting or drug 25359 endovascular prostheses are not addressed in this document. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e. This document can be helpful in identifying the appropriate evaluation isi 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 izo 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 considered as a supplement to Iowhich specifies general requirements for the performance of non-active surgical implants.

Monday to Friday – 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.

This document can be considered as a supplement to ISOwhich specifies general requirements for the performance of non-active surgical implants. Cardiovascular implants – Endovascular devices – Part 1: 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 jso are not described for these devices.

Proof sent to secretariat or FDIS ballot initiated: Pharmacological aspects of drug is or drug coated endovascular prostheses are not addressed in this document. Endovascular prostheses ISO Du abonnerer allerede dette emne. 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 25539 scope of this document. Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses.

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Pharmacological aspects of drug eluting or drug coated 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. Guidance for the development of in vitro test methods is included in an informative annex to this document.

Similarly, specific ieo 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.

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

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

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

Forkert brugernavn eller adgangskode. Life cycle A standard is reviewed every 5 years 00 Preliminary.

Guidance for the development of in vitro test methods is included in an informative annex to this document. The requirements for, and the 2553 of, degradation and other time-dependant aspects of absorbable materials used in the construction of endovascular prostheses are not addressed in this document.