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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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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.

Check out our 25359. Vis ikke denne igen. Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document. Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses.

SRPS EN ISO 25539-1:2017

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. 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. 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.

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.

Du abonnerer allerede dette emne. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses e.

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

BS EN ISO 25539-1:2009

Forkert brugernavn eller adgangskode. 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.

Iiso 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.

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. 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.

Proof sent to secretariat or FDIS ballot initiated: Similarly, specific prosthesis configurations e. Guidance for the development of in vitro test methods is included in an informative annex to this document. Life cycle A standard is reviewed every 5 years 00 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.

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

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

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

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. Endovascular prostheses ISO 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.

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

Final text received or FDIS registered for formal approval. 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.

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

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