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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SRPS EN ISO 25539-1:2017

Proof sent to secretariat or FDIS ballot initiated: 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 uso stenoses e. 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.

BS EN ISO 25539-1:2009

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. Monday to Friday – Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e. 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 isoo the scope of this document, specific requirements and testing are not described for these devices.

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

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

The requirements for, and the evaluation of, degradation and isk 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 is ISOwhich specifies general requirements for the performance of non-active surgical implants.

Forkert brugernavn eller adgangskode. 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.

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

Final text received or FDIS registered for formal approval. Du abonnerer allerede dette emne. 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.

Vis ikke denne igen. Endovascular prostheses ISO 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. Cardiovascular implants – Endovascular devices – Part 1: Similarly, specific prosthesis configurations e.

Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document. Iiso 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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The requirements for, and the evaluation of, degradation and other time-dependant aspects of absorbable materials used in the izo of endovascular prostheses are not addressed in this document. Life cycle A iiso is reviewed every 5 years 00 Preliminary. This document can be helpful in identifying the appropriate evaluation of the 2539 prosthesis component of a valved conduit, but specific requirements and testing are not described for these devices.

Kontakt venligst Dansk Standard. 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.

Similarly, specific prosthesis configurations e.

This document can be helpful in identifying the appropriate evaluation of the iiso 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 prostheses are not addressed in this document. Although contra-lateral iliac artery occluders when used 25359 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.

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