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

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. Balloons used to achieve adequate apposition of the prosthesis with the vessel wall or overlapping components are within isk scope of this document, even if they are not integral to the endovascular system.

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. sio

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

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Guidance for the development of in vitro test methods is included in an informative annex to this document. Du abonnerer allerede dette emne.

Monday to Friday – 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.

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

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.

Kontakt venligst Dansk Standard. 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 – Cardiovascular Implants. Endovascular devices. Endovascular prostheses

Vis ikke denne igen. 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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Final text received or FDIS registered for formal approval. 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 is 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.

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

SRPS EN ISO 25539-1:2017

This document can be considered as a isp to ISOwhich specifies general requirements for the performance of non-active surgical implants. Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses.

Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document. Proof sent to secretariat or FDIS ballot initiated: Endovascular prostheses ISO Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document. 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.

Cardiovascular implants – Endovascular devices – Part 1: