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

BS EN ISO 25539-1:2009

Proof sent to secretariat or FDIS ballot initiated: 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.

Some of the requirements are specific to isi 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 isoo this document, even if they are not integral to the endovascular system.

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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 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 is 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.

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

Final text received or FDIS registered for formal approval. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e. 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 255399 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. 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.

Monday to Friday – 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. Life cycle A standard is reviewed every 5 years 00 Preliminary. Vis ikke denne igen. 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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Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document.

SRPS EN ISO 25539-1:2017

Guidance for the development of in vitro test methods is included in an informative annex to this document. Similarly, specific prosthesis configurations 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. 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: Forkert brugernavn eller adgangskode.

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

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

This document can be considered as a supplement 225539 ISOwhich specifies general requirements for the performance of non-active surgical implants. Endovascular prostheses Iiso 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.

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