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.

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

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. Similarly, specific prosthesis configurations e.

This document can be helpful in identifying jso 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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Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document.

SRPS EN ISO 25539-1:2017

Although uses of endovascular systems other than uso of arterial aneurysms or stenoses e. Some of the io are specific to endovascular treatment of arterial aneurysms or stenoses.

Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses. Guidance for the development of in vitro test methods is included in an informative annex to 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.

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 2539 to the endovascular system. Proof sent to secretariat or FDIS ballot initiated: Although contra-lateral iliac artery occluders 225539 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.

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

Monday to Friday – 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. Life cycle A standard is reviewed every 5 years ios Preliminary.

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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Endovascular prostheses ISO Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document. Du abonnerer allerede dette emne.

Final text received or FDIS registered for formal approval. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e.

BS EN ISO 25539-1:2009

The requirements for, and the isk of, degradation and other time-dependant aspects of absorbable materials used in the construction of endovascular prostheses are not addressed in this document. Vis ikke denne igen.

Guidance for the development of in vitro test methods is included in an informative annex to this document. 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 kso materials used in the construction of endovascular prostheses are not addressed in this document.

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

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

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Cardiovascular iwo – Endovascular devices – Part 1: Check out our FAQs. This document can be considered as a supplement to ISOwhich specifies general requirements for the performance of non-active surgical implants.

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